Comparison 1: Perineal local cooling compared with no pain relief or usual care

Five trials (744 women) were included in the comparison of localized perineal cooling compared with no intervention or usual care. One trial compared ice packs with usual care. Two three-arm trials compared ice packs versus cold gel packs versus no intervention (and for this comparison women allocated to any of the cooling interventions were analysed together). Another trial compared cold gel packs with hygienic, absorbent maternity pads.

Maternal outcomes

Relief of symptoms: It is uncertain whether perineal local cooling reduces perineal pain within 4–6 hours of birth, within 24 hours of birth, or 24–48 hours after birth (using a scale of 0 = no pain to 10 = worst possible pain), when compared with no intervention (very low-certainty evidence). It is uncertain whether perineal local cooling reduces moderate or severe perineal pain within 24 hours of birth, when compared with no intervention (very low-certainty evidence). Low-certainty evidence suggests perineal local cooling may reduce moderate or severe perineal pain 24–48 hours after birth, when compared with no intervention (1 trial, 316 women; RR 0.73, 95% CI 0.57 to 0.94). However, these results should be considered with caution due to the high rate of attrition (29.8%). Low-certainty evidence suggests perineal local cooling may make little or no difference to perineal oedema within 24 hours of birth, when compared with no intervention (1 trial, 316 women; RR 1.00, 95% CI 0.87 to 1.16). It is uncertain whether perineal local cooling reduces perineal oedema 24–48 hours after birth, when compared with no intervention (very low-certainty evidence). Low-certainty evidence suggests perineal local cooling may make little or no difference to perineal bruising within 24 hours of birth (1 trial, 316 women; RR 0.98, 95% CI 0.81 to 1.19); it is uncertain whether perineal local cooling reduces perineal bruising 24–48 hours after birth, when compared with no intervention (very low-certainty evidence). It is uncertain whether perineal local cooling effects the composite score including perineal redness, oedema, bruising, discharge, and wound gaping within 24 hours of birth, or 24–48 hours after birth, when compared with no intervention (very low-certainty evidence).

Health service use: It is uncertain whether perineal local cooling affects the use of additional non-prescription or prescription analgesia for relief of perineal pain within 24 hours, or 24–48 hours after birth, when compared with no intervention (very low-certainty evidence).

Maternal functioning/well-being: Low-certainty evidence suggests perineal local cooling may make little or no difference to women’s self-assessed moderate and severe perineal pain associated with sitting within 24 hours (1 trial, 312 women; RR 1.03, 95% CI 0.98 to 1.09) or 24–48 hours after birth (1 trial, 312 women; RR 1.00, 95% CI 0.95 to 1.05), compared with no intervention. Low-certainty evidence suggests perineal local cooling may make little or no difference to women’s self-assessed moderate and severe pain associated with walking within 24 hours (1 trial, 312 women; RR 1.00, 95% CI 0.94 to 1.08) or 24–48 hours after birth (1 trial, 312 women; RR 1.01, 95% CI 0.93 to 1.09), when compared with no intervention. It is uncertain whether perineal local cooling affects women’s self-assessed moderate and severe pain associated with feeding the baby within 24 or 24–48 hours after birth, when compared with no intervention (very low-certainty evidence).

Experience of postnatal care: Low-certainty evidence suggests perineal local cooling may make little or no difference to maternal satisfaction with overall perineal care at day 10 after birth, when compared with no intervention (1 trial, 308 women; RR 1.07, 95% CI 0.97 to 1.18).

Adverse effects directly related to the use of cooling techniques (e.g. cold burn) were not reported in the systematic review.

Newborn outcomes

Breastfeeding status: It is uncertain whether perineal local cooling affects the number of women providing any breastmilk to the baby 24–48 hours after birth (very low-certainty evidence).

Comparison 2: Perineal local cooling compared with other forms of non-pharmacological perineal pain relief

Additional considerations

Whether the effects of the interventions differed by type of perineal trauma (episiotomy versus tear) is unknown, as no such subgroup analyses were included in the systematic review (included subgroup analyses were parity and mode of birth).

Additional considerations

Non-pharmacological interventions such as local cooling are relatively inexpensive where the necessary infrastructure and facilities already exist.

Additional considerations

Access to clean water, refrigeration, ice, cold storage and gel pads is limited in many low-income countries.

Table 3.1

Main resource requirements for local cooling for perineal pain relief.

Table 3.2

Summary of judgements: Local cooling compared with no pain relief or usual care.

Table 3.3

Summary of judgements: Local cooling compared with other forms of non-pharmacological perineal pain relief.

Comparison 1: Single-dose oral analgesic (any dose) compared with placebo

Comparison 2: Single-dose oral analgesic compared with a higher single dose of the same analgesic

Comparison 3: Single-dose oral analgesic compared with a single dose of an alternative oral analgesic

Additional considerations

Other forms of pharmacological perineal pain relief were not considered, including rectal analgesics (54, 55) and topically applied anaesthetics for treating perineal pain after childbirth (56).

Additional considerations

Some women may decline paracetamol due to fears of harmful effects on the baby through breastmilk. Women who use paracetamol need clear information about the dose of paracetamol in any concurrent medications, to help avoid inadvertent overdose or toxicity (51). Generally, it is anticipated that women will accept single-dose, oral analgesics with clear information about safety.

Table 3.4

Main resource requirements of oral analgesia for perineal pain relief.

Additional considerations

Generally, oral analgesics are widely-available at low cost. Aspirin is contraindicated during breastfeeding, but may be considered for use in non-breastfeeding women. The only non-opioid and non-steroidal anti-inflammatory medicines listed in the WHO Model List of Essential Medicines are acetylsalicylic acid (aspirin) (tablet: 100 mg to 500 mg; suppository: 50 mg to 150 mg), ibuprofen (tablet: 200 mg, 400 mg, 600 mg), and paracetamol (tablet: 100 mg to 500 mg; suppository: 100 mg) (58).

Table 3.5

Summary of judgements: Single-dose oral analgesic (any dose) compared with placebo.

Table 3.6

Summary of judgements: Single-dose oral analgesic compared with a higher single dose of the same analgesic.

Table 3.7

Summary of judgements: Single-dose oral analgesic compared with a single dose of an alternative oral analgesic.

Comparison 1: Paracetamol (oral, single-dose) compared with placebo

Maternal outcomes

Relief of symptoms: It is uncertain whether paracetamol (650 mg) provides adequate pain relief for uterine cramping/involution when compared with placebo (very low-certainty evidence).

Health service use: It is uncertain whether paracetamol (1000 mg) affects the need for additional pain relief for uterine cramping/involution when compared with placebo (very low-certainty evidence).

Adverse effects: It is uncertain whether paracetamol has any effect on adverse effects when compared with placebo (very low-certainty evidence). Subgroup analyses according to dose of paracetamol (650 mg or 1000 mg) showed the same level of uncertainty.

Maternal functioning/well-being and experience of postnatal care were not reported in the included trials.

Newborn outcomes

Breastfeeding status and adverse effects were not reported in the included trials.

Additional considerations

Paracetamol is considered safe during breastfeeding (59). Although a single case of a rash on the upper trunk of a breastfeeding infant has been described, the American Academy of Pediatrics considers paracetamol compatible with breastfeeding. No other adverse effects of paracetamol exposure through breastmilk have been reported. Following the mother’s treatment with 1000 mg of paracetamol, it has been estimated that the maximum dose her infant is exposed to is less than 2% of the maternal dose (59).

Additional considerations

Women should be informed of the effects (desirable and undesirable) of the respective available pharmacological options to relieve pain due to uterine cramping/involution.

Additional considerations

Some women may decline paracetamol due to fears of harmful effects on the baby through breastmilk. Women who use paracetamol need clear information about the dose of paracetamol in any concurrent medications to help avoid inadvertent overdose or toxicity (51). Generally, it is anticipated that women will accept single-dose, oral analgesics with clear information about safety.

Additional considerations

Generally, paracetamol is widely available at low cost. Paracetamol (tablet: 100 mg to 500 mg; suppository: 100 mg) is listed in the WHO Model List of Essential Medicines (58).

Table 3.8

Main resource requirements for paracetamol (oral, single-dose).

Table 3.9

Summary of judgements: Paracetamol (oral, single-dose) compared with placebo.

Comparison 2: NSAIDs compared with placebo

Maternal outcomes

Relief of symptoms: Low-certainty evidence suggests NSAIDs may provide adequate pain relief for uterine cramping/involution when compared with placebo (11 trials, 946 women; RR 1.66, 95% CI 1.45 to 1.91). Subgroup analyses according to the type of NSAIDs showed:

• Aspirin 650 mg: Low-certainty evidence suggests aspirin 650 mg may provide adequate pain relief for uterine cramping/involution when compared with placebo (6 trials, 282 women; RR 1.33, 95% CI 1.09 to 1.61).
• Other NSAIDs: It is uncertain whether naproxen 275 mg, 300 mg, 550 mg or 600mg, flurbiprofen 50 mg, ketorolac 5 mg or 10 mg, or fenoprofen 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg or 300 mg provides adequate pain relief for uterine cramping/involution when compared with placebo (very low-certainty evidence).

Health service use: It is uncertain whether NSAIDs reduce the need for additional pain relief for uterine cramping/involution when compared with placebo (very low-certainty evidence). Subgroup analyses according to type of NSAIDs (aspirin 650 mg; ketorolac 5 mg or 10 mg; naproxen 275 mg, 300 mg, 550 mg and 600 mg) showed the same level of uncertainty.

Adverse effects: It is uncertain whether NSAIDs affect adverse effects when compared with placebo (very low-certainty evidence). Subgroup analyses according to type of NSAIDs (aspirin 650 mg; fenoprofen 200 mg; flurbiprofen 50 mg; ketorolac 5 mg or 10 mg; naproxen 275 mg, 300 mg, 550 mg and 600 mg) showed the same level of uncertainty.

Maternal functioning/well-being and experience of postnatal care were not reported in the included trials.

Newborn outcomes

Breastfeeding status and adverse effects were not reported in the included trials.

Table 3.10

Main resource requirements for NSAIDs.

Additional considerations

Additional considerations around equity are the same as for Comparison 1: Paracetamol (oral, single-dose) compared with placebo.

Additional considerations

Some women may decline to use medications due to fears of harmful effects on the baby through breastmilk. Women who use medications to relieve pain need clear information about dosage and contraindications. Generally, it is anticipated that women will accept single-dose, oral analgesics with clear information about safety.

Additional considerations

Generally, NSAIDs are widely available at low cost.

The only non-steroidal anti-inflammatory medicines listed in the WHO Model List of Essential Medicines are acetylsalicylic acid (aspirin) (tablet: 100 mg to 500 mg; suppository: 50 mg to 150 mg) and ibuprofen (tablet: 200 mg; 400 mg; 600 mg) (58).

Table 3.11

Summary of judgements: NSAIDs compared with placebo.

Comparison 3: Opioids compared with placebo

Maternal outcomes

Relief of symptoms: It is uncertain whether opioids provide adequate pain relief for uterine cramping/involution when compared with placebo (very low-certainty evidence). Subgroup analyses according to dose of opioid (codeine 60 mg or 120 mg) showed the same level of uncertainty.

Health service use: It is uncertain whether opioids affect the need for additional pain relief for uterine cramping/involution when compared with placebo (very low-certainty evidence). Subgroup analyses according to type and dose of opioid (codeine 60 mg or 120 mg, and nalbuphine 15 mg) showed the same level of uncertainty.

Adverse effects: It is uncertain whether opioids affect adverse effects when compared with placebo (very low-certainty evidence). Subgroup analyses according to dose of opioid (codeine 60 mg or 120 mg) showed the same level of uncertainty.

Maternal functioning/well-being and experience of postnatal care were not reported in the included trials.

Newborn outcomes

Breastfeeding status and adverse effects were not reported in the included trials.

Table 3.12

Main resource requirements for opioids.

Additional considerations

While in some high-resource settings oral opioid drugs are considered relatively inexpensive, these drugs may not be accessible in all settings and may not be affordable in some LMICs.

Additional considerations

Additional considerations around equity are the same as in the previous comparisons.

Additional considerations

Some women may decline opioids due to fears of adverse effects and harmful effects on the baby through breastmilk. Some women may decline opioids due to the need to rely on health workers to administer the medication.

Feasibility

See Box 3.3 in section 3.A.2: Interventions for common physiological signs and symptoms.

Table 3.13

Summary of judgements: Opioids compared with placebo.

Additional considerations

In lower-resource settings, where opioids are not widely available and used, there are likely to be financial implications as well as additional training requirements for their administration and the management of potential maternal and neonatal adverse effects. It is likely that the type of opioid used in different settings and countries would be influenced by the cost of the medication.

Codeine phosphate (tablet: 30 mg) is listed in the WHO Model List of Essential Medicines (58).

Comparison 1: Lower dose of an oral analgesic compared with a higher dose of the same analgesic

Additional considerations

There is no large variation in cost based on dosage of the same class of analgesic.

Additional considerations

Women should be informed of the effects (desirable and undesirable) of the respective available pharmacological options to relieve pain due to uterine cramping/involution.

Table 3.14

Main resource requirements for the oral analgesics.

Additional considerations

Some women may decline medications due to fears of harmful effects on the baby through breastmilk. Women who use medications to relieve pain need clear information about dosage and contraindications. Generally, it is anticipated that women will accept single-dose, oral analgesics with clear information about safety. Women may prefer to use the lowest dose possible to relief pain due to uterine cramping/involution.

Additional considerations

Health workers would generally prefer to prescribe analgesics using the lowest dose possible, and to prescribe those associated with fewer adverse effects.

In lower-resource settings, where opioids are not widely available and used, there are likely to be financial implications as well as additional training requirements for their administration and the management of potential maternal and neonatal adverse effects. It is likely that the type of opioid used in different settings and countries would be influenced by the cost of the medication.

The only non-opioids and non-steroidal anti-inflammatory medicines listed in the WHO Model List of Essential Medicines are acetylsalicylic acid (aspirin) (tablet: 100 mg to 500 mg; suppository: 50 mg to 150 mg), ibuprofen (tablet: 200 mg; 400 mg; 600 mg), and paracetamol (tablet: 100 mg to 500 mg; suppository: 100 mg) (58).

The opioid codeine phosphate (tablet: 30 mg) is listed in the WHO Model List of Essential Medicines (58).

Table 3.15

Summary of judgements: Lower dose of an oral analgesic compared with a higher dose of the same analgesic.

Comparison 2: An oral analgesic compared with an alternative oral analgesic of the same class

Additional considerations

Additional considerations around the effects of the medications on pain due to uterine cramping/involution are the same as for Comparison 1: Lower dose of an oral analgesic compared with a higher dose of the same analgesic.

Additional considerations

Additional considerations around equity are the same as for Comparison 1: Lower dose of an oral analgesic compared with a higher dose of the same analgesic.

Additional considerations

Additional considerations around acceptability are the same as for Comparison 1: Lower dose of an oral analgesic compared with a higher dose of the same analgesic.

Additional considerations

Additional considerations around feasibility are the same as for Comparison 1: Lower dose of an oral analgesic compared with a higher dose of the same analgesic.

Table 3.16

Summary of judgements: An oral analgesic compared with an alternative oral analgesic of the same class.

Comparison 3: An oral analgesic compared with an alternative oral analgesic from a different class

Comparison 3c: NSAIDs compared with herbal analgesia

Maternal outcomes

Relief of symptoms: Moderate-certainty evidence suggests NSAIDs probably provide adequate pain relief for uterine cramping/involution when compared with herbal analgesia (4 trials, 394 women; RR 0.96, 95% CI 0.78 to 1.18). Subgroup analyses according to the type and dose of analgesic showed the following.

• It is uncertain whether mefenamic acid 250 mg provides adequate pain relief for uterine cramping/involution when compared with pimpinella anisum, apium graveolens and crocus sativus 500 mg, Melissa officinalis 395 mg, or fennel 300 mg (very low-certainty evidence).
• It is uncertain whether ibuprofen 400 mg provides adequate pain relief for uterine cramping/involution when compared with fennel essence 20% (very low-certainty evidence).

Health service use: It is uncertain whether NSAIDs affect the need for additional pain relief for uterine cramping/involution when compared with herbal analgesia (very low-certainty evidence). Subgroup analyses according to type and dose of analgesic (ibuprofen 400 mg versus fennel essence 20%) showed the same level of uncertainty

Adverse effects: It is uncertain whether NSAIDs have any effect on adverse effects when compared with herbal analgesia (very low-certainty evidence). Subgroup analyses according to type and dose of analgesic (mefenamic acid 250 mg versus pimpinella anisum, apium graveolens and crocus sativus 500 mg) showed the same level of uncertainty.

Health service use, maternal functioning/well-being and experience of postnatal care were not reported in the included trials.

Newborn outcomes

Breastfeeding status and adverse effects were not reported in the included trials.

Values

See Box 3.1 in section 3.A.2: Interventions for common physiological signs and symptoms.

Resources

No economic evaluations of pharmacological treatments for relieving pain due to uterine cramping/involution were identified.

Table 3.17

Main resource requirements for the oral analgesics assessed.

Equity

No direct evidence was identified on the impact on health equity of pharmacological treatments for the relief of pain due to uterine cramping/involution. Other evidence around equity is the same as for the previous comparisons.

Additional considerations

Additional considerations around equity are the same as for the previous comparisons.

Additional considerations

Additional considerations around acceptability are the same as for the previous comparisons.

Additional considerations

Additional considerations around feasibility are the same as for the previous comparisons.

Table 3.18

Summary of judgements: An oral analgesic compared with an alternative oral analgesic from a different class.

Comparison 1: Postnatal PFMT compared with no intervention or usual care for (mixed) prevention or treatment of incontinence

Relief of symptoms: Low-certainty evidence suggests PFMT may improve urinary incontinence in the early postnatal period (0–3 months) when compared with no PFMT (2 trials, 321 women; RR 0.54, 95% CI 0.44 to 0.66). It is uncertain whether PFMT affects urinary incontinence in the mid-postnatal period (> 3–6 months) when compared with usual care (very low-certainty evidence). Low-certainty evidence suggests PFMT may have little or no effect on urinary incontinence in the late postnatal period (> 6–12 months) when compared with no PFMT or usual care (3 trials, 826 women; RR 0.88, 95% CI 0.71 to 1.09). It is uncertain whether PFMT affects faecal incontinence in the early postnatal period (0–3 months) or faecal incontinence in the late postnatal period (> 6–12 months) when compared with no PFMT (very low-certainty evidence).

Maternal functioning/well-being: It is uncertain whether PFMT affects postnatal quality of life (related to urinary incontinence) when compared with no PFMT (very low-certainty evidence).

Long-term maternal morbidity and adverse effects were not reported in the included trials. Experience of postnatal care was not reported in the systematic review.

Comparison 2: Postnatal PFMT compared with no intervention or usual care for treatment of incontinence

Relief of symptoms: It is uncertain whether PFMT affects urinary incontinence in the late postnatal period (> 6–12 months) following childbirth compared with control (very low-certainty evidence). It is uncertain whether PFMT affects faecal incontinence in the late postnatal period (> 6–12 months).

Long-term maternal morbidity: Low-certainty evidence suggests PFMT may make little or no difference to urinary incontinence in the long term (> 5–10 years) when compared with usual care (1 trial, 516 women; RR 0.96, 95% CI 0.88 to 1.05). Low-certainty evidence suggests PFMT may make little or no difference to urinary incontinence in the very long term (> 10 years) when compared with usual care (1 trial, 471 women; RR 1.03, 95% CI 0.94 to 1.12). It is uncertain whether PFMT affects faecal incontinence in the long term (> 5–10 years), or faecal incontinence in the very long term (> 10 years), when compared with usual care (very low-certainty evidence).

Maternal functioning/well-being: It is uncertain whether PFMT affects urinary incontinence-specific quality of life when compared with usual care (very low-certainty evidence).

Adverse effects were not reported in the included trials. Experience of postnatal care was not reported in the systematic review.

Additional considerations

Additional evidence from the Cochrane systematic review (48) suggests beginning PFMT early in pregnancy probably prevents urinary incontinence in late pregnancy and reduces the risk of incontinence during the postpartum period, in particular at three to six months postpartum. There is insufficient evidence on the effects beyond six months postpartum.

Additional considerations

The Cochrane systematic review identified one protocol for an ongoing economic evaluation conducted alongside a RCT (240 pregnant and/or postpartum women with stress urinary incontinence; anticipated completion December 2020) (60). For PFMT programmes with a supervised component (either as part of initial training or for the full duration on the programme), PFMT provided as part of a group may be more cost-effective than providing individual sessions (60).

Table 3.19

Main resource requirements for postnatal PFMT for pelvic floor strengthening.

Additional considerations

An interpretive synthesis of individual, professional and service issues associated with the implementation of PFMT for childbearing women (61) reported PFMT may not be easily accessible to non-English speaking women or women with low health literacy. Some women may feel a sense of shame because of symptoms of urinary incontinence and may refrain from disclosing the issue to their care providers (61).

Feasibility

A qualitative evidence synthesis of women’s experiences of postnatal care found no direct evidence relating to women’s views on the feasibility of using PFMT for the prevention or treatment of urinary or faecal incontinence (28). Indirect evidence indicates that women may find it difficult to accommodate a PFMT programme as they struggle with competing demands on their time and prioritize the needs of their baby (high confidence in the evidence).

A qualitative evidence synthesis of health workers’ experiences of postnatal care found no direct evidence relating to views on the feasibility of using PFMT for the prevention or treatment of urinary or faecal incontinence (29). However, indirect evidence suggests that lack of personnel, resources and training may limit the offer PFMT, provision of information, and counselling on potential pelvic floor problems in the postnatal period (moderate confidence in the evidence).

An interpretive synthesis of individual, professional and service issues associated with the implementation of PFMT for childbearing women (61) reported women lack knowledge of urinary incontinence and PFMT that may diminish their likelihood of engaging with such training. As there may be some taboo and fatalism surrounding urinary incontinence following childbirth, some women may not feel comfortable discussing symptoms or treatment with their care providers (61). Likewise, health workers may be reluctant to raise the issue with women as part of routine care (61). The synthesis noted a lack of training and support for midwives to complete requisite training to enable delivery of PFMT as part of maternity care, and limited access to specialist physiotherapists in some regions (61). The synthesis also reported that postnatal women performing PFMT would value assessment to confirm whether they are carrying out pelvic floor muscle contractions correctly. However, objective assessment may not be a part of regular service provision, and the acceptability of such an assessment to midwives and women is unknown (61).

Table 3.20

Summary of judgements: Postnatal PFMT compared with usual care or no intervention.

Comparison 1: Cabbage leaf extract cream compared with placebo

One trial (39 women) compared a 1% cabbage leaf extract cream versus a placebo cream.

Maternal outcomes

Relief of symptoms: It is uncertain whether the use of a cream with 1% cabbage leaf extract reduces breast pain or breast engorgement (measured using a six-point, self-rated scale developed by Hill and Humenick)⁶ when compared with placebo cream (very low-certainty evidence).

Adverse effects and maternal functioning/well-being were not reported in the included trial. Short-term maternal morbidity, health service use and experience of postnatal care were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status was not reported in the included trial. Adverse effects were not reported in the systematic review.

Additional considerations

Health workers would generally place high value on promoting breastfeeding and on interventions that may help them to provide better advice and support to breastfeeding women.

Resources

No economic evaluations of non-pharmacological interventions for treating breast engorgement following childbirth were identified.

Table 3.21

Main resource requirements for cabbage leaf extract cream.

Additional considerations

Even though the health, emotional, psychosocial and societal benefits of breastfeeding to women and children is recognized, breastfeeding rates worldwide are suboptimal, especially among low-income women. Increasing breastfeeding initiation and duration among low-income women, including prevention of breast problems that may affect breastfeeding continuation, would not only offer improved health benefits to the mother and infant, but would lessen the economic burden on this group within the community (65, 66).

Additional considerations

Most women would probably accept a simple intervention involving application of cream to the breasts to reduce engorgement and potentially prevent complications such as mastitis. However, some breastfeeding women may be reluctant to apply a cream directly to the breast, if they are concerned about their baby ingesting the cream while feeding and/or if they have to remove the cream before breastfeeding.

Additional considerations

Application of cream is a simple and easy intervention that is expected to be feasibly implemented in most settings.

Table 3.22

Summary of judgements: Cabbage leaf extract cream compared with placebo.

Comparison 2: Cold cabbage leaves applied directly to the breast compared with usual care

One three-arm trial (228 women) compared the use of cold cabbage leaves applied directly to the breast with either usual care (including daily, in-house postnatal classes during rounds conducted by lactation consultants, and brochures in the hospital) or cold gel packs. The cold cabbage leaves versus standard care arm is considered in this comparison.

Maternal outcomes

Relief of symptoms: Moderate-certainty evidence suggests cold cabbage leaves probably reduce breast pain when compared with usual care (1 trial, 152 women; MD 1.03 lower, 95% CI 1.53 lower to 0.53 lower). Moderate-certainty evidence suggests cold cabbage leaves probably reduce breast hardness (measured using a breast engorgement assessment scale) when compared with usual care (1 trial, 152 women; MD 0.58 lower, 95% CI 0.82 lower to 0.34 lower).

Maternal functioning/well-being: Moderate-certainty evidence suggests cold cabbage leaves probably increase women’s satisfaction (satisfied or very satisfied) when compared with usual care (1 trial 152 women; RR 1.42, 95% CI 1.22 to 1.64).

Adverse effects were not reported in the included trial. Short-term maternal morbidity, health service use and experience of postnatal care were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding duration: Low-certainty evidence suggests cold cabbage leaves may make little or no difference to the risk of cessation of breastfeeding before six months when compared with usual care (1 trial, 108 women; RR 1.75, 95% CI 0.93 to 3.30).

Adverse effects were not reported in the systematic review.

Additional considerations

Additional considerations around the values of health workers are the same as for Comparison 1: Cabbage leaf extract cream compared with placebo.

Resources

No economic evaluations of non-pharmacological interventions for treating breast engorgement following childbirth were identified.

Table 3.23

Main resource requirements for cold cabbage leaves applied directly to the breast.

Additional considerations

Additional considerations around equity are the same as for Comparison 1: Cabbage leaf extract cream compared with placebo.

Additional considerations

Most women would probably accept a simple intervention such as application of cold cabbage leaves to the breasts to reduce engorgement and potentially prevent complications such as mastitis.

Additional considerations

Access to refrigeration and clean water is limited in many low-income settings. Access to fresh produce may also be limited in some settings.

Table 3.24

Summary of judgements: Cold cabbage leaves compared with usual care.

Comparison 3: Cold gel packs applied directly to the breast compared with usual care

One three-arm trial (228 women) compared the use of cold cabbage leaves directly applied to the breast with either standard care or cold gel packs. The cold gel packs (chilled gel pack applied to each breast for 2 hours followed by half hour break before repeat application) plus usual care, versus usual care alone (including daily in-house postnatal classes during rounds conducted by lactation consultants, brochures in the hospital) is considered in this comparison. Another trial (88 women) compared breast-shaped cold gel packs (worn 15–20 minutes after two consecutive feeds) with usual care. Results of this trial were not included in the summary tables of the review due to high rates of crossover among groups.

Maternal outcomes

Relief of symptoms: Low-certainty evidence suggests cold gel packs may make little or no difference to breast pain when compared with usual care (1 trial, 151 women; MD 0.4 lower, 95% CI 0.91 lower to 0.11 higher). Moderate-certainty evidence suggests cold gel packs probably reduce the number of women with breast hardness when compared with usual care (1 trial, 151 women; MD 0.34 lower, 95% CI 0.6 lower to 0.08 lower).

Maternal functioning/well-being: Low-certainty evidence suggests cold gel packs may make little or no difference to women’s satisfaction (the number of women who were satisfied or very satisfied) when compared with usual care (1 trial, 151 women; RR 1.17, 95% CI 0.97 to 1.40).

Adverse effects were not reported in the included trial. Short-term maternal morbidity, health service use and experience of postnatal care were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status: Low-certainty evidence suggests cold gel packs may make little or no difference to cessation of breastfeeding before six months when compared with usual care (1 trial, 109 women; RR 1.03, 95% CI 0.50 to 2.14).

Adverse effects were not reported in the systematic review.

Additional considerations

Additional considerations around the values of health workers are the same as for the previous comparisons.

Equity

No direct evidence was identified on the impact on health equity of pharmacological interventions for treating breast engorgement following childbirth. The impact of cold gel packs on health equity is likely to vary across settings. These treatments require access to refrigeration and cold storage, which is limited in many low-income countries. Availability of gel pads may also be limited in these settings.

Table 3.25

Main resource requirements for cold gel packs applied directly to the breasts.

Additional considerations

Additional considerations around equity are the same as for the previous comparisons.

Additional considerations

Most women would probably accept a simple intervention such as application of gel packs to the breasts to reduce engorgement and potentially prevent complications such as mastitis.

Additional considerations

Access to refrigeration and gel pads is limited in many low-income countries.

Table 3.26

Summary of judgements: Cold gel packs applied directly to the breasts compared with usual care.

Comparison 4: Warm herbal compresses compared with usual care (including warm compresses without herbs)

Three trials (610 women) compared warm or hot herbal compresses with usual care (including warm compresses without herbs). One trial compared hot herbal compress balls (with Cassumunar ginger, turmeric and camphor) with compress balls without herbs (500 women). Another trial compared warm compresses followed by hollyhock leaf compresses with warm compresses alone (40 women). The last trial compared warm ginger compresses with routine care (76 women), but results were reported per individual breast and therefore were not included in the systematic review.

Maternal outcomes

Relief of symptoms: Moderate-certainty evidence suggests herbal compress balls probably reduce breast pain when compared with usual care (including warm compress balls without herbs) (1 trial, 500 women; MD 1.8 lower, 95% CI 2.07 lower to 1.53 lower). It is uncertain whether hollyhock leaf compresses have any effect on breast engorgement when compared with usual care (including warm compresses without herbs).

Adverse effects: It is uncertain whether herbal compress balls have any effect on adverse effects when compared with usual care (very low-certainty evidence).

Maternal functioning/well-being was not reported in the included trials. Short-term maternal morbidity, health service use and experience of postnatal care were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status was not reported in the included trial. Adverse effects were not reported in the systematic review.

Additional considerations

The trial reported that two women in the herbal compress balls group experienced skin irritation compared with none in the control group (2/250 and 0/250, respectively).

Additional considerations

Additional considerations around the values of health workers are the same as for the previous comparisons.

Additional considerations

A herbalist may be required to prepare hollyhock solution. In some settings, women might be able to prepare this and other herbal solutions themselves at home.

Additional considerations

Additional considerations around equity are the same as for the previous comparisons.

Additional considerations

Most women would probably accept a simple intervention such as application of a warm herbal compress applied to the breasts to reduce engorgement and potentially prevent complications such as mastitis.

Additional considerations

Feasibility may be limited in settings where the materials can only be provided by a herbalist or similar and cannot be accessed locally and/or prepared at home.

Table 3.27

Main resource requirements for warm compresses (with or without herbs).

Table 3.28

Summary of judgements: Warm compresses (with or without herbs) compared with usual care.

Comparison 5: Breast massage compared with usual care (without breast massage)

One trial compared Oketani breast massage⁷ versus usual care (education on proper breastfeeding techniques, frequent breastfeeding and hot compress). The trial was excluded from the analyses as the results were reported per individual breast rather than per woman.

Another three-arm trial (200 women) compared breast massage alternating with cactus and aloe cold compresses, with cactus and aloe cold compresses alone, as well as with breast massage alone. Review authors only presented in this comparison the arms evaluating massage therapy plus cactus and aloe compresses versus cactus and aloe compresses alone; the arms comparing breast massage only versus cactus and aloe compresses alone were not presented in the review.

Additional considerations

The Cochrane systematic review included two trials considering ultrasound therapy and one on electromechanical massage. These trials were not included in this framework as ultrasound therapy was considered technically demanding and not feasible at the global level.

Additional considerations

Additional considerations around the values of health workers are the same as for the previous comparisons.

Additional considerations

The cost of breast massage provided by professional massage therapists could be relatively high, depending on location and setting.

Table 3.29

Main resource requirements for breast massage.

Additional considerations

Additional considerations around equity are the same as for the previous comparisons.

Additional considerations

Feasibility may be limited in settings where breast massage can only be performed by a specialist massage therapist. Where maternity staff can access training to provide breast massage, or massage is self-administered, the intervention may be feasible.

Table 3.30

Summary of judgements: Breast massage compared with usual care.

Comparison 1: Subcutaneous oxytocin compared with placebo

One trial (45 women) compared daily oxytocin 2.5 IU given subcutaneously until breasts became soft versus placebo.

Maternal outcomes

Relief of symptoms: It is uncertain whether the use of subcutaneous oxytocin has any effect on breast engorgement at three days of treatment when compared with placebo (very low-certainty evidence).

Adverse effects were not reported in the included trial. Short-term maternal morbidity, health service use, maternal functioning/well-being, and experience of postnatal care were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status and adverse effects were not reported in the systematic review.

Additional considerations

No trials assessed the effects and safety of other forms of oxytocin (oral or nasal spray) on breast engorgement.

Additional considerations

Health workers would generally place high value on promoting breastfeeding and on interventions that may help them to provide better advice and support to breastfeeding women.

Resources

No economic evaluations of pharmacological interventions for treating breast engorgement were identified.

Table 3.31

Main resource requirements for subcutaneous oxytocin.

Additional considerations

Even though the health, emotional, psychosocial and societal benefits of breastfeeding to women and children are recognized, breastfeeding rates worldwide are suboptimal, especially among low-income women. Increasing breastfeeding initiation and duration among low-income women, including prevention of breast problems that may affect breastfeeding continuation, would not only offer improved health benefits to the mother and infant, but would lessen the economic burden on this group within the community (65, 66).

Additional considerations

An invasive and painful procedure involving a daily injection may not be acceptable to many women, especially given limited evidence on its effects, and where other pharmacological and nonpharmacological treatment options are available.

Additional considerations

Resource constraints may influence effective use of oxytocin in LMICs. Inconsistent supplies and reservations about oxytocin storage in areas with limited/inconsistent electricity hinder utilization. However, injectable oxytocin may be available in health facilities as it is already widely used globally for other indications (e.g. the prevention and treatment of postpartum haemorrhage, and induction of labour).

Oxytocin (10 IU in 1 ml for injection) is listed in the WHO Model List of Essential Medicines (58).

Table 3.32

Summary of judgements: Subcutaneous oxytocin compared with placebo.

Comparison 2: Proteolytic enzymes compared with placebo

Additional considerations

Included trials reported no adverse effects in either the protease, serrapeptase, or placebo group.

Bromelain and serrapeptase are also marketed as dietary/nutritional supplements and are widely available for purchase without a prescription. A systematic review of the evidence around use of serratiopeptidase concluded there is insufficient evidence to support its use as an analgesic and health supplement (71).

Equity

No direct evidence was identified on the impact on health equity of pharmacological interventions for treating breast engorgement following childbirth. Proteolytic enzymes may be prohibitively expensive for some women, and therefore may decrease equity. Their availability is also likely to vary by region. However, proteolytic enzymes may have no effect on or may increase equity where the treatments are provided by health facilities.

Table 3.33

Main resource requirements for proteolytic enzymes.

Additional considerations

Additional considerations around equity are the same as for Comparison 1: Subcutaneous oxytocin compared with placebo.

Additional considerations

It is anticipated that swallowing tablets containing ingredients to assist the body in breaking down protein would be an acceptable intervention for most women. However, with limited information about the safety profile of proteolytic enzymes, such as the long-term safety of serrapeptase (71), it is unlikely that breastfeeding women will accept this intervention.

Additional considerations

Proteolytic enzymes are available in some settings, over-the-counter or online, as a dietary supplement.

Indicative prices suggest these supplements might be prohibitively expensive for some women.

No proteolytic enzymes are listed in the WHO Model List of Essential Medicines (58).

Table 3.34

Summary of judgements: Proteolytic enzymes compared with placebo.

Comparison 1: Probiotics compared with placebo

Probiotics were given daily in the form of capsules containing Lactobacillus fermentum 3 in one trial (625 women). Results of the largest trial conducted in Australia (639 women) are unavailable due to a contractual agreement between the probiotics supplier and the trialists.

Maternal outcomes

Prevention of symptoms: It is uncertain whether probiotics reduce the number of women with nipple damage within six months postpartum, or breast pain (very low-certainty evidence).

Short-term maternal morbidity: Low-certainty evidence suggests probiotics may make little or no difference to the risk of mastitis when compared with placebo (1 trial, 291 women; RR 0.58, 95% CI 0.33 to 1.02).

Maternal functioning/well-being and adverse effects were not reported in the included trials. Health service use and experience of postnatal care was not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status was not reported in the included trials and adverse effects were not reported in the systematic review.

Additional considerations

The largest trial evaluating probiotics (639 women), which compared probiotics with placebo, was the trial for which no data were available due to restrictions imposed on the trial authors by the intervention manufacturer. With only one other trial included in this comparison, it is likely that the inclusion of these data would substantially impact the overall results.

Another Cochrane systematic review on the effectiveness and safety of treatments for breast engorgement during lactation – including 21 trials (2170 women) – was updated in 2020 (49). While mastitis was a pre-specified outcome for the review, trials did not include mastitis as an outcome.

Additional considerations

Health workers would generally place high value on promoting breastfeeding and on interventions that may help them to provide better advice and support to breastfeeding women.

Additional considerations

Even though the health, emotional, psychosocial and societal benefits to women and children of breastfeeding are recognized, breastfeeding rates worldwide are suboptimal, especially among low-income women. Increasing breastfeeding initiation and duration among low-income women, including prevention of breast problems that may affect breastfeeding continuation, would not only offer improved health benefits to the mother and infant, but would lessen the economic burden experienced by this group within the community (65, 66).

Table 3.35

Main resource requirements for probiotics.

Additional considerations

It is anticipated that probiotics as sachets, tablets or capsules would be an acceptable intervention to most women.

Additional considerations

Probiotics may be prohibitively expensive for some women. Some probiotics may require refrigeration or must be stored below a certain temperature (e.g. below 25 °C), which may not be feasible in some settings. The shelf-life of probiotics must also be considered.

Table 3.36

Summary of judgements: Probiotics compared with placebo.

Comparison 2: Hydrothermally processed cereal with anti-secretory factor-inducing properties compared with standard cereal (serving as a placebo)

The trial (40 women) contributing to this comparison considered hydrothermally processed cereals (which induce the production of anti-secretory factor [AF] in human milk) versus non-treated cereal (as a placebo).

Maternal outcomes

Short-term maternal morbidity: It is uncertain whether hydrothermally processed cereal reduces the incidence of mastitis within six months postpartum, or within 12 months postpartum, when compared with standard cereal (very low-certainty evidence).

Maternal functioning/well-being was not reported in the included trial. Prevention of symptoms, health service use, experience of postnatal care, and adverse effects were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status was not reported in the included trial and adverse effects were not reported in the systematic review.

Additional considerations

Additional considerations around the values of health workers are the same as for Comparison 1: Probiotics compared with placebo.

Equity

No direct evidence was identified on the impact on health equity of non-pharmacological interventions for preventing mastitis following childbirth. The impact on equity of AF-inducing foods is likely to vary by their regional availability and cost. However, AF-inducing foods may decrease equity as they are unlikely to be supplied by health facilities and may be prohibitively expensive for many women.

Other considerations around equity are the same as for Comparison 1: Probiotics compared with placebo.

Table 3.37

Main resource requirements for hydrothermally processed cereal with AF-inducing properties.

Additional considerations

Additional considerations around equity are the same as for Comparison 1: Probiotics compared with placebo.

Additional considerations

It is anticipated that AF-inducing foods such as treated cereals would be an acceptable intervention for most women.

Additional considerations

AF-inducing foods such as treated cereals may be prohibitively expensive for many women. Their regional availability is likely to vary.

Table 3.38

Summary of judgements: Hydrothermally processed cereal with AFinducing properties compared with standard cereal (serving as a placebo).

Comparison 3: Specialist breastfeeding education compared with usual care

The trial (211 women) contributing to this comparison considered in-hospital specialist breastfeeding education (a 30-minute personal session with a lactation consultant and a nurse) versus usual care (early breastfeeding, advice on breastfeeding techniques and support in case of difficult breastfeeding).

Maternal outcomes

Prevention of symptoms: It is uncertain whether specialist breastfeeding education reduces the risk of breast pain (defined in the trial as sore nipples) at hospital discharge, at 7 days and at 30 days, when compared with usual care (very low-certainty evidence). It is uncertain whether specialist breastfeeding education reduces the risk of breast engorgement at any of these time points when compared with usual care (very low-certainty evidence).

Short-term maternal morbidity: It is uncertain whether specialist breastfeeding education reduces the risk of women developing mastitis at hospital discharge, at 7 days and at 30 days, when compared with usual care (very low-certainty evidence).

Maternal functioning/well-being was not reported in the included trial and health service use, experience of postnatal care, and adverse effects were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status: Low-certainty evidence suggests specialist breastfeeding education may make little or no difference to exclusive breastfeeding at seven days (1 trial, 169 women; RR 1.03, 95% CI 0.90 to 1.18). It is uncertain whether specialist breastfeeding education affects exclusive breastfeeding at 30 days (very low-certainty evidence).

Adverse effects were not reported in the systematic review.

Additional considerations

For the purpose of the comparisons in this evidence summary, early breastfeeding and breastfeeding advice and/or support (not including specialist advice) was deemed usual care. Such advice should be the minimum standard for quality postnatal care in all facilities.

Another Cochrane systematic review of 21 trials (2170 women) on the effectiveness and safety of treatments for breast engorgement during lactation was updated in 2020 (49). While mastitis was a pre-specified outcome for the review, trials did not include mastitis as an outcome.

Additional considerations

Qualitative evidence on breastfeeding counselling has shown that both women and health workers highly value breastfeeding counselling (76). It has also shown that women wanted more counselling and stressed the importance of follow-up. When provided or proactively sought out by women, counselling is highly valued and increased satisfaction.

Additional considerations

The cost of lactation specialists could be relatively high, depending on location and setting. Where midwives and nurses can gain the necessary training to provide specialist lactation support, costs may be lowered. However, the cost of training itself may also be considerable.

Additional considerations

Additional considerations around equity are the same as for the previous comparisons.

Additional considerations

Another systematic review of qualitative studies on breastfeeding counselling found that breastfeeding counselling was highly valued by women and health workers. It was acknowledged that health workers may be reticent to counsel if not properly trained and allocated sufficient time for counselling (76). Variability in acceptability was judged as minor.

Table 3.39

Main resource requirements for specialist breastfeeding education.

Additional considerations

To enable quality counselling, the provision of appropriate training, coaching, and support for health workers and lay/non-lay counsellors by skilled trainers is essential. Trained counsellors need sufficient time for counselling. Health workers would prefer to have more time and resources, in order to provide better quality counselling (76). The feasibility of specialist breastfeeding education is therefore likely to vary based on access to personnel, resources and training.

Table 3.40

Summary of judgements: Specialist breastfeeding education compared with usual care.

Comparison 4: Acupoint massage compared with usual care

The trial (400 women) contributing to this comparison considered breast acupoint massage⁸ with usual care (early breastfeeding, breastfeeding advice on positioning and attachment and breastfeeding on-demand).

Maternal outcomes

Prevention of symptoms: Moderate-certainty evidence suggests acupoint massage probably reduces the risk of breast pain when compared with usual care (1 trial, 400 women; RR 0.13, 95% CI 0.07 to 0.23). Moderate-certainty evidence suggests acupoint massage probably reduces the risk of breast engorgement when compared with usual care (1 trial, 400 women; RR 0.49, 95% CI 0.37 to 0.65).

Short-term maternal morbidity: Moderate-certainty evidence suggests acupoint massage probably reduces the incidence of mastitis within six months postpartum when compared with usual care (1 trial, 400 women; RR 0.38, 95% CI 0.19 to 0.78).

Maternal functioning/well-being: Moderate-certainty evidence suggests acupoint massage probably improves women’s perception of milk supply (moderate or better) when compared with usual care (1 trial, 400 women; RR 1.26, 95% CI 1.13 to 1.40).

Health service use, experience of postnatal care, and adverse effects were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status: Moderate-certainty evidence suggests that acupoint massage probably increases exclusive breastfeeding (at 42 days postpartum) when compared with usual care (1 trial, 400 women; RR 1.90, 95% CI 1.58 to 2.29).

Adverse effects were not reported in the systematic review.

Additional considerations

The cost of acupoint massage provided by professional massage therapists could be relatively high, depending on location and setting.

Equity

No direct evidence was identified on the impact on health equity of non-pharmacological interventions for preventing mastitis following childbirth. Accupoint breast massage may decrease equity, as it can be difficult for women to access due to limited service availability and potential out-of-pocket costs, in particular if the service is provided by specialist personnel. Where acupoint breast massage can be performed by midwives or other health personnel, or self-administered with instruction, it may have no effect on or may increase equity.

Table 3.41

Main resource requirements for acupoint massage.

Additional considerations

Additional considerations around equity are the same as for the previous comparisons.

Additional considerations

It is anticipated that acupoint massage would be acceptable for most women. Although pressure is applied to the breast, the amount of pressure applied should never induce pain.

Additional considerations

Accupoint breast massage may be feasible in settings where midwives or other health personnel can access the necessary training and provide it, but this will vary across health facilities. Accupoint massage may also be self-administered following instructions from trained personnel.

Table 3.42

Summary of judgements: Acupoint massage compared with usual care.

Comparison 1: Oral prophylactic antibiotics compared with placebo or usual care

Comparison 2: Topical prophylactic antibiotics compared with usual care (breastfeeding advice)

This comparison includes data from arm three of the four-arm trial (84 women) described above.

Maternal outcomes

Short-term maternal morbidity: Low-certainty evidence suggests that topical fusidic acid ointment (1 trial, 40 women; RR 0.77, 95% CI 0.27 to 2.22) may make little or no difference to the incidence of mastitis within six months postpartum when compared with usual care. Low-certainty evidence suggests that topical mupirocin ointment (1 trial, 48 women; RR 0.39, 95% CI 0.12 to 1.35) may make little or no difference to the incidence of mastitis within six months postpartum when compared with usual care.

Maternal functioning/well-being and adverse effects were not reported in the included trial. Health service use and experience of postnatal care were not reported in the systematic review.

Newborn/infant outcomes

Breastfeeding status was not reported in the included trial and adverse effects were not reported in the systematic review.

Additional considerations

Another Cochrane systematic review on the effectiveness and safety of treatments for breast engorgement during lactation including 21 trials (2170 women) was updated in 2020 (49). While mastitis was a pre-specified outcome for the review, trials did not include mastitis as an outcome.

A 2013 Cochrane systematic review on the effectiveness of antibiotic therapies for relieving symptoms for breastfeeding women with mastitis with or without laboratory investigation found insufficient evidence to confirm or refute the effectiveness of antibiotic therapy for the treatment of lactational mastitis (77).

Additional considerations

Most women may prefer to avoid the inconvenience and adverse effects of antibiotic use.

Table 3.43

Main resource requirements for pharmacological interventions to prevent mastitis.

Health workers and policy-makers are likely to place a high value on the potential impact of antibiotic use on antibiotic resistance. There may be no variation in this value across settings.

Additional considerations

Even though the recognized health, emotional, psychosocial and societal benefits of breastfeeding to women and children, breastfeeding rates worldwide are sub-optimal, especially among low-income women. Increasing breastfeeding initiation and duration among low-income women, including prevention of breast problems that may affect breastfeeding continuation, would not only offer improved health benefits to the mother and infant, but would lessen the economic burden experienced by this group within the community (65, 66).

Additional considerations

One trial in the Cochrane systematic review was ceased prematurely due to difficulties in recruitment arising from the demands of motherhood and reluctance to take antibiotics among some women (50).

Given concerns about adverse effects and antibiotic resistance, it is possible that many women and health workers will be reluctant to take/prescribe antibiotics in the absence of a confirmed infection, and without clear evidence of benefit.

Some breastfeeding women may be reluctant to apply a cream directly to the breast, if they are concerned about their baby ingesting the cream while feeding and/or if they have to remove the cream before breastfeeding.

Feasibility

A qualitative evidence synthesis of women’s experiences of postnatal care found no direct evidence relating to women’s views on the feasibility of using prophylactic antibiotics to treat mastitis (28). Indirect evidence from the same review indicates that some women in LMICs may be less likely to seek help for this type of problem if they perceive that health facilities lack the resources to offer appropriate treatments or if they believe the preventive strategy will incur additional costs (moderate confidence in the evidence).

Table 3.44

Summary of judgements: Oral prophylactic antibiotics compared with placebo or usual care.

Additional considerations

The antibiotics listed under the WHO Model List of Essential Medicines “access group antibiotics” (those that have wide activity against pathogens and lower resistance potential) that are suitable for skin and soft tissue infections are amoxicillin plus clavulanic acid (as a first-choice treatment), cloxacillin (as a first-choice treatment) and cephalexin (as a second-choice treatment) (58). Oral administration is preferred for cloxacillin due to better bioavailability (58).

Table 3.45

Summary of judgements: Topical prophylactic antibiotics versus usual care (breastfeeding advice).

Comparison: Laxatives compared with placebo

Two eligible trials (755 women) examined the effectiveness and safety of a laxative versus placebo. These trials were published in 1960 and 1980, and compared active senna or dioctyl-sodium succinate plus active senna versus placebo.

Maternal outcomes

Symptoms of constipation – time to first bowel movements (days): Low-certainty evidence suggests laxatives may result in more women having their first bowel movement less than 24 hours after birth when compared with placebo (1 trial, 471 women; RR 2.90, 95% CI 2.24 to 3.75). It is uncertain whether laxatives affect the number of women having their first bowel movement on day 1 after birth (very low-certainty evidence). Low-certainty evidence suggests laxatives may result in fewer women having their first bowel movement on day 2 after birth (1 trial, 471 women; RR 0.23, 95% CI 0.11 to 0.45). It is uncertain whether laxatives affect the number of women having their first bowel movement on day 3 or on day 4 after birth (both very low-certainty evidence). None of the trials reported on other symptoms of constipation, such as pain or straining during defecation, incidence of postpartum constipation as per self-report or stool consistency.

Health service use: It is uncertain whether laxatives affect the number of postpartum enemas given (very low-certainty evidence).

Adverse effects: It is uncertain whether laxatives affect the incidence of abdominal cramps (very low-certainty evidence).

Maternal functioning/well-being was not reported in the included trials and experience of postnatal care was not reported in the systematic review.

Newborn/infant outcomes

Adverse effects: It is uncertain whether laxatives affect the incidence of neonatal loose stools and diarrhoea (very low-certainty evidence).

Additional considerations

None of the trials assessed non-pharmacological interventions, such as dietary advice and modification, promotion of healthy physical activities, correct bodily positioning for defecation, use of herbs, or traditional and complementary medicine.

There is some concern around the use of dioctyl-sodium succinate, which was evaluated together with senna in one of the eligible trials. The drug is reported to be ineffective and potentially unsuitable for use during breastfeeding (74). Some laxatives may interfere with the body’s absorption of vitamins and mineral supplements (16).

Acceptability

A qualitative evidence synthesis of women’s experiences of postnatal care found no direct evidence relating to women’s views on pharmacological or nonpharmacological treatments for preventing/relieving postpartum constipation (28). Indirect evidence from this review suggests that women may appreciate any techniques or treatments that provide relief from constipation (high confidence in the evidence) as they are likely to aid comfort, mobility and psychosocial well-being (high confidence in the evidence). However, findings from the same review also indicate that, in specific contexts, women may be reluctant to use either pharmacological or non-pharmacological interventions as they adhere to strict dietary routines associated with traditional postnatal practices (low confidence in the evidence).

Table 3.46

Main resource requirements for prevention of postpartum constipation.

Additional considerations

Indirect evidence from a qualitative evidence synthesis exploring uptake of antenatal care (80) indicates that women in a variety of LMICs are more likely to turn to traditional healers, herbal remedies, or traditional birth attendants to treat constipation (moderate confidence).

Feasibility

A qualitative evidence synthesis of women’s experiences of postnatal care found no direct evidence relating to women’s views on the feasibility of using pharmacological or non-pharmacological interventions for preventing constipation (28).

Table 3.47

Summary of judgements: Laxatives compared with placebo.

A qualitative evidence synthesis of health workers’ experiences of postnatal care found no direct evidence relating to views on the feasibility of using pharmacological or non-pharmacological interventions for preventing constipation (29). However, indirect evidence suggests a lack of personnel, resources and training may limit the offer of dietary advice and pharmacological treatments to address this problem (moderate confidence in the evidence).

Additional considerations

The only laxative drug listed in the WHO Model List of Essential Medicines is senna (58), recommended for use only if dietary interventions have been ineffective (81).

It is anticipated that moderate changes to diet would be feasible for most women.

Table 3.48

Summary of judgements: Nonpharmacological intervention (diet and lifestyle advice) compared with no intervention.

Comparison: Screening for common mental disorders (depression, anxiety) in the postpartum period compared with no screening or usual care

Maternal outcomes

Mental health condition

Postpartum depression

• Evidence from RCTs: Low-certainty evidence suggests screening for common mental disorders in postpartum women may reduce the rate of postpartum depression when compared with usual care (4 trials, 3164 women; OR 0.53, 95% CI 0.45 to 0.62).
• Evidence from quasi-RCTs: Low-certainty evidence suggests screening for common mental disorders in postpartum women may reduce the rate of postpartum depression when compared with usual care (2 trials, 5010 women; OR 0.30, 95% CI 0.24 to 0.48).

Postpartum anxiety

• Evidence from RCTs: High-certainty evidence suggests screening for common mental disorders in postpartum women reduces postpartum anxiety when compared with usual care (1 trial, 565 women; MD 0.28 fewer, 95% CI 0.44 fewer to 0.11 fewer).
• Evidence from quasi-RCTs: It is uncertain whether screening for common mental disorders in postpartum women affects the postpartum anxiety rate when compared with usual care (very low-certainty evidence).

Maternal functioning/well-being

• Evidence from RCTs: Low-certainty evidence suggests screening for common mental disorders in postpartum women may improve quality of life when compared with usual care (2 trials, 2068 women; MD 0.24, 95% CI 0.11 to 0.38). Moderate-certainty evidence suggests screening for common mental disorders in postpartum women probably makes little or no difference to marital satisfaction when compared with usual care (2 trials, 1017 women; OR 0.56 lower, 95% CI 0.21 to 1.53).
• Evidence from quasi-RCTs: It is uncertain whether screening for common mental disorders in postpartum women affects quality of life when compared with usual care (very low-certainty evidence).

Short-term maternal morbidity

• Evidence from RCTs: High-certainty evidence suggests screening for common postpartum mental disorders reduces parental stress when compared with usual care (3 trials, 1582 women; OR 0.57, 95% CI 0.45 to 0.74).
• Evidence from quasi-RCTs: It is uncertain whether screening for common mental disorders in postpartum women affects parental stress when compared with usual care (very low-certainty evidence).

Health service use

• Evidence from RCTs: Low-certainty evidence suggests screening for common postpartum mental disorders may increase treatment seeking practices when compared with usual care (2 trials, 1017 women; OR 3.45, 95% CI 2.52 to 4.70).

Adverse effects: The review authors were not able to pool results for adverse effects reported in two studies (4546 women). One trial (462 women) reported no adverse effects. The other trial (4084 women) reported no hospital or psychiatric admissions due to adverse events. Contacts with other mental health or social workers were rare in the screening group.

Experience of postnatal care was not reported in the included trials, and subgroup analyses were not possible due to the limited number of studies.

Additional considerations

The systematic review reported additional neonatal/infant outcomes that were not included in this evidence summary. Infant outcomes were reported in three studies, showing a small improvement in child socioemotional development in the intervention group (SMD = −0.10, 95% CI −0.16 to −0.04, 4050 infants, I² = 0%). No improvement was perceived in physical development of the infants (SMD = 0.09, 95% CI −0.02 to 0.19, 1486 infants, I² = 0%). One study reported an improvement in parent-child interaction (SMD = 0.32, 95% CI 0.13 to 0.52, n = 565, I² = 26.52%). The number of doctor visits for the child increased among the intervention group (SMD = 0.19, 95% CI 0.01 to 0.34, n = 462). However, no differences were noted in number of hospitalizations (SMD = 0.06, 95% CI −0.13 to 0.24, n = 462).

The primary publication of this systematic review included three trials (914 women) where screening for common postpartum mental disorders was conducted during pregnancy. It revealed a reduction in rates of depressive symptoms among women in the postpartum period (OR 0.68, 95% CI 0.48 to 0.96).

Resources

The systematic review identified one study (high quality) evaluating cost-effectiveness of screening programmes (89). General screening for postpartum depression was done either face-to-face or through postal questionnaires. The women who screened positive for postpartum depression were either offered treatment based on cognitive behavioural approaches or non-directive counselling. In the case of severe symptoms such as suicidality, women were referred for psychiatric support. The intervention group reported a greater number of quality-adjusted life-year (QALY) (+0.003, 95% CI 0.001 to 0.006) and fewer total costs (−36.035, 95% CI −68.423 to −3.646). The trial arm receiving cognitive behavioural approaches reported a higher rise in QALYs, was more cost-effective and also reported fewer contacts with health services. When QALYs were considered to range between £20 000 and £30 000, the probability for cost-effectiveness was over 70% for this group.

Table 3.49

Main resource requirements for screening for common mental disorders (depression, anxiety) in the postpartum period.

Additional considerations

Women affected by social inequalities have an increased risk of many common postpartum mental disorders and their adverse consequences (90).

Additional considerations

Several qualitative studies exploring women’s perceptions of screening tools for postnatal depression (92) suggest that tools like the EPDS are useful to women as long as they are not used as an end point, simply to confirm or rule out depression, but rather as a starting point for a genuine conversation about psychosocial well-being. For some women there was a perception that mental health screening might be viewed as a test for so called normality, leading to subsequent concerns about feeling stigmatized. Other women felt that screening could be intrusive and insensitive and highlighted the importance of kind, well trained staff in the screening process.

Additional considerations

Screening for postpartum depression can be embedded in routine health-care information systems or in population-based screening at community level through household surveys.

After screening for common postpartum mental disorders, provision of diagnosis and treatment should be a priority for health systems. The preferred choice and acceptability for delivery agents should also be explored. In some settings, seeking treatment from general practitioners for mental health conditions may not be accepted due to the belief that general practitioners are more suitable for treating physical conditions (89).

Table 3.50

Summary of judgements: Screening for common mental disorders (depression, anxiety) in the postpartum period compared with no screening or usual care.

Comparison: Interventions to prevent common mental disorders (depression, anxiety) in the postpartum period, delivered at any time, compared with no intervention or usual care

Maternal outcomes

Mental health condition

Postpartum depression

Moderate-certainty evidence suggests interventions to prevent common postpartum mental disorders, with components delivered at any time point, probably reduce the rate of postpartum depression when compared with no interventions or usual care (9 trials, 1831 women; OR 0.61, 95% CI 0.38 to 0.99). Low-certainty evidence suggests interventions to prevent common postpartum mental disorders, with components delivered at any time point, may reduce postpartum depression severity when compared with no interventions or usual care (38 trials, 20 569 women; SMD 0.29 lower, 95% CI 0.44 lower to 0.15 lower).

Postpartum anxiety

Moderate-certainty evidence suggests interventions to prevent common postpartum mental disorders, with components delivered at any time point, probably reduce the rate of postpartum anxiety (4 trials; OR 0.20, 95% CI 0.04 to 0.89), and postpartum anxiety severity (9 trials, 1796 women; SMD 0.79 lower, 95% CI 1.30 lower to 0.28 lower), when compared with no interventions or usual care.

Maternal functioning/well-being: Moderate-certainty evidence suggests interventions to prevent mental disorders, with components delivered at any time point, probably reduce marital discord (7 trials, 1563 women; SMD 0.33 lower, 95% CI 0.54 lower to 0.12 lower), and probably improve maternal infant attachment (6 trials, 2078 women; SMD 0.11 lower, 95% CI 0.20 lower to 0.02 lower), when compared with no intervention or usual care. Low-certainty evidence suggests interventions to prevent mental disorders, with components delivered any time point, may have little or no effect on perceived social support (9 trials, 8416 women; SMD 0.002 higher, 95% CI 0.05 lower to 0.05 higher), exclusive breastfeeding (1 trial, 2438 women; OR 1.02, 95% CI 0.81 to 1.27), or breastfeeding initiation practices (2 trials, 1210 women; OR 1.10, 95% CI 0.90 to 1.33), when compared with no intervention or usual care.

Short-term maternal morbidity: Low-certainty evidence suggests interventions to prevent mental disorders with components delivered at any time point may have little or no effect on paternal stress when compared with no intervention or usual care (4 trials, 592 women; SMD 0.07 higher, 95% CI 0.21 lower to 0.34 higher).

Experience of postnatal care: Low-certainty evidence suggests interventions to prevent mental disorders, with components delivered at any time point, may reduce maternal dissatisfaction when compared with no intervention or usual care (8 trials, 4007 women; SMD 0.36 lower, 95% CI 0.60 lower to 0.12 lower).

Health service use: It is uncertain whether interventions to prevent maternal mental disorders, with components delivered antenatally, have an effect on treatment seeking practices when compared with no interventions or usual care (very low-certainty evidence).

Adverse effects were not reported in the included trials.

Outcomes by time of intervention (antenatal only, antenatal and postpartum, postpartum only)

Mental health condition

Postpartum depression

• Interventions delivered in the antenatal period only: It is uncertain whether interventions to prevent common postpartum mental disorders with components delivered antenatally have an effect on the rate of postpartum depression when compared with no intervention or usual care (very low-certainty evidence).
• Interventions with components delivered in both, antenatal and postpartum periods: Low-certainty evidence suggests interventions to prevent mental disorders with components delivered both antenatally and postnatally may have little or no effect on the rate of postpartum depression when compared with no intervention or usual care (5 trials 594 women; OR 0.57, 95% CI 0.27 to 1.18).
• Interventions delivered in the postpartum period only: Moderate-certainty evidence suggests interventions to prevent common postpartum mental disorders with components delivered postnatally probably have little or no effect on the rate of postpartum depression when compared with no intervention or usual care (2 trials, 1012 women; OR 0.82, 95% CI 0.48 to 1.41).

Postpartum depression severity

• Interventions delivered in the antenatal period only: Low-certainty evidence suggests interventions to prevent common postpartum mental disorders with components delivered antenatally may reduce postpartum depression severity when compared with no intervention or usual care (9 trials, 3006 women; MD 0.70 lower, 95% CI 1.17 lower to 0.24 lower).
• Interventions with components delivered in both antenatal and postpartum periods: Moderate-certainty evidence suggests interventions to prevent common postpartum mental disorders with components delivered both antenatally and postnatally probably reduce postpartum depression severity when compared with no intervention or usual care (14 trials, 3485 women; MD 0.10 lower, 95% CI 0.20 lower to 0.01 lower).
• Interventions delivered in the postpartum period only: It is uncertain whether interventions to prevent common postpartum mental disorders with components delivered postnatally have an effect on postpartum depression severity when compared with no intervention or usual care (very low-certainty evidence).

Postpartum anxiety severity

• Interventions delivered in the antenatal period only: It is uncertain whether interventions to prevent common postpartum mental disorders with components delivered in the antenatal period have an effect on severity of postpartum anxiety when compared with no intervention or usual care (very low-certainty evidence).
• Interventions with components delivered in both antenatal and postpartum periods: Low-certainty evidence suggests that interventions to prevent common postpartum mental disorders with components delivered both antenatally and postnatally may have little or no effect on postpartum anxiety severity when compared with no intervention or usual care (3 trials, 171 women, MD 0.20 lower, 95% CI 0.50 lower to 0.11 higher).
• Interventions with components delivered in the postpartum period only: Moderate-certainty evidence suggests that interventions to prevent common postpartum mental disorders with components delivered postnatally probably reduce the severity of postpartum anxiety when compared with no interventions or usual care (4 trials, 1193 women; MD 0.45 lower, 95% CI 0.88 lower to 0.02 lower).

Additional considerations

Additional analyses were performed to evaluate the effectiveness of included interventions in improving postpartum depressive symptoms, by type of intervention and population focus. Twenty-one studies targeted populations with risk factors or prodromal symptoms of depression, and 20 of these focused on universal populations. Interventions designed for universal populations had a greater effect on postpartum depressive symptoms (SMD = −0.33, 95% CI −0.57 to −0.10) than their counterparts (SMD = −0.21, 95% CI −0.33 to −0.09). However, this subgroup analysis did not achieve statistical significance (P = 0.64). Twenty-six studies reported on the effectiveness of psychosocial interventions for depressive symptoms while 15 were underpinned by a psychological theory. Psychological interventions had a greater effect on postpartum depressive symptoms (SMD = −0.44, 95% CI −0.77 to −0.10) than their counterparts (SMD = −0.22, 95% CI −0.40 to −0.05). However, this subgroup analysis did not achieve statistical significance (P = 0.20).

Resources

The systematic review identified two studies evaluating cost-effectiveness of prevention interventions for common postpartum mental disorders. One study (high quality) presented a cost-effectiveness analysis for a volunteer-based programme for the prevention of postpartum depression among high risk women in Canada, and reported a mean cost per woman of Can$ 4497 in the peer support group and Can$ 3380 in the usual care group (difference of Can$ 1117, P < 0.0001) (95). There was a 95% probability that the programme would cost less than Can$ 20 196 per case of postpartum depression averted. Although this was a volunteer-based programme, it resulted in a net cost to the health system and society. However, this cost was within the range for other accepted interventions for this population (95). Another study (moderate quality) evaluated the psychoeducational intervention for postpartum women “What Were We Thinking”, reporting no difference in costs between the intervention recipients and their control counterparts (96). The incremental cost-effectiveness ratios were AU$ 36 451 per QALY gained and AU$ 152 per percentage point reduction in 30-day prevalence of depression, anxiety, and adjustment disorders. The estimate lies under the unofficial cost-effectiveness threshold of AU$ 55 000 per QALY; however, there was considerable variability surrounding the results, with a 55% probability that the programme would be considered cost-effective at that threshold (96).

Table 3.51

Main resource requirements for interventions to prevent common mental disorders (depression, anxiety) in the postpartum period.

Additional considerations

Women affected by social inequalities have increased risk of many common postpartum mental disorders and their adverse consequences (90).

Additional considerations

Several qualitative studies (97–99) exploring women’s postpartum mental health indicate that women sometimes struggle to identify mental health conditions and/or don’t know who to approach or how to access support. They may feel overwhelmed or inadequate and develop coping strategies or engage in self-denial to disguise mental health concerns. Findings also indicate that women appreciate regular home visits from health workers provided the support offered is empowering rather than undermining or patronizing.

Additional considerations

Integrating psychosocial and psychological interventions for prevention of common postpartum mental disorders into routine maternal and child health service will enhance feasibility. Delivery of interventions by trained non-specialists also enhances feasibility.

Table 3.52

Summary of judgements: Interventions to prevent common mental disorders (depression, anxiety) in the postpartum period, delivered at any time, compared with no intervention or usual care.

Comparison: Universal newborn screening for abnormalities of the eye compared with no screening

Newborn/infant outcomes

Severe neonatal/infant morbidity: Low-certainty evidence suggests universal screening for abnormal eye conditions in maternity wards may increase the proportion of newborns with congenital cataract referred from maternity wards or well-baby clinics in the first year after birth compared with no screening (1 study, 394 438 infants; RR 9.83, 95% CI 1.36 to 71.20). It is uncertain whether universal screening for abnormal eye conditions in well-baby clinics has any effect on the proportion of newborns with congenital cataract referred from maternity wards or well-baby clinics in the first year after birth compared with no screening (very low-certainty evidence). It is uncertain whether universal screening for abnormal eye conditions has any effect on the proportion of newborns with congenital cataract referred from any health facility (maternity ward, well-baby clinic, by a paediatrician, or other) in the first year after birth compared with no screening, when screening is done in either maternity wards or well-baby clinics (very low-certainty evidence). Low-certainty evidence suggests universal screening for abnormal eye conditions in maternity wards may increase the proportion of newborns with congenital cataract referred within 42 days of birth when compared with no screening (1 study, 394 438; RR 4.61, 95% CI 1.12 to 19.01). It is uncertain whether universal screening for abnormal eye conditions in well-baby clinics has any effect on the proportion of newborns with congenital cataract referred within 42 days of birth when compared with no screening (very low-certainty evidence).

Health service use: Low-certainty evidence suggests universal screening for abnormalities of the eye in maternity wards may increase the proportion of newborns with congenital cataract operated on within 42 days of birth compared with no screening (1 study, 394 438 infants; RR 8.23, 95% CI 1.13 to 59.80). It is uncertain whether universal screening for abnormalities of the eye in well-baby clinics has any effect on the proportion of newborns with congenital cataract operated on within 42 days of birth compared with no screening (very low-certainty evidence).

Adverse effects: Low-certainty evidence suggests that universal screening for abnormal eye conditions using red reflex testing may increase the occurrence of clinical conjunctivitis compared with no screening (1 study, 18 870; OR 1.22, 95% CI 1.01 to 1.47). It is uncertain whether universal screening for abnormal eye conditions using red reflex testing increases the occurrence of bacterial conjunctivitis compared with no screening (very low-certainty evidence).

Neonatal/infant mortality and neurodevelopment were not reported in the included studies.

Maternal outcomes

Experience of postnatal care and cost were not reported in the included studies.

Data analyses for the pre-specified subgroups were not possible as the data were not available.

Additional considerations

One study (7641 healthy newborns) demonstrated high specificity (96.0%, 95% CI 95.6 to 96.5%) of red reflex testing using a direct ophthalmoscope for anterior segment and posterior segment conditions, and all conditions combined, when compared with the gold standard of a comprehensive eye examination (including digital imaging and indirect ophthalmoscopy or ultrasound as required) (119), but sensitivity was 0% for posterior segment conditions and 66.7% (with wide confidence intervals) for anterior segment conditions.

A comparative study based on data from the Paediatric Cataract Register (PECARE) found that, among all the congenital cataract cases operated in the first year after birth, 13 per 100 000 children (561 743 newborns) were referred within 42 days (that is, by eight weeks) of birth when screened by early red reflex testing compared with 1.3 per 100 000 (population 308 181 newborns) who were screened using torch light examination (120).

Additional considerations

One study included in the systematic review assessed the cost-effectiveness of universal eye screening using red reflex testing in well-baby clinics and maternity units, compared with maternity unit screening only (121). As universal screening was not compared with no screening, the study did not provide data relevant to this evidence summary.

Table 3.53

Main resource requirements for universal newborn screening for abnormalities of the eye.

Additional considerations

Evidence from a systematic review suggests that girls with bilateral cataract are less likely to access cataract surgery than boys in some regions, particularly in South Asia and East Asia, and the Pacific (126). There is also variation in age and stage at presentation of retinoblastoma by country-income groups, with children in HICs presenting at lower median age and with lower rates of advanced stage VI disease compared with LMICs (127). Early screening, identification and counselling will raise awareness among parents and may help to increase access to services.

Additional considerations

A pilot study in the United Republic of Tanzania showed that including an eye care module in the child health training programme for 60 primary child health-care workers on red reflex testing using the Arclight™ increased health workers’ knowledge, was acceptable and that they were able to implement it within routine care (128).

In another study in the United Republic of Tanzania, 24 nurses were trained to screen the eyes of children aged 0–5 years using Arclight™ red reflex testing and reported that that parents were happy and willing to let their children be screened (129).

Additional considerations

A study in the United Republic of Tanzania assessed the feasibility of Arclight red reflex screening for children aged 0–5 years in primary health-care settings by trained nurses (129). Most nurses reported they could differentiate a normal from an abnormal red reflex very easily or easily, that examining newborns less than four weeks old was more difficult and that the examination took less than 3 minutes. However, screening interfered with their day-to-day activities because of staff shortages, large numbers of children and multiple responsibilities. Care is needed in extrapolating some these findings to newborns who are more difficult to screen using the red reflex test than older children.

Table 3.54

Summary of judgements: Universal eye screening compared with no screening.

Comparison: UNHS compared with no screening or selective screening (no UNHS)

Newborn/infant outcomes

Severe neonatal/infant morbidity: Low-certainty evidence suggests UNHS may make little or no difference to the proportion of infants identified with PBHL when compared with no UNHS (3 studies, 1 023 497 newborns; RR 1.01, 95% CI 0.89 to 1.14). Low-certainty evidence suggests UNHS may improve the proportion of infants identified with PBHL early (before 9 months of age) when compared with no UNHS (1 study, 156 733 newborns; RR 3.28, 95% CI 1.84 to 5.85). It is uncertain whether UNHS in newborns with bilateral hearing loss improves the mean age of identification of PBHL when compared with no UNHS (very low-certainty evidence).

Neurodevelopment: It is uncertain whether UNHS in newborns with PBHL has any effect on mean receptive language at 3–8 years of age (z score and development quotient), mean expressive language at 3–8 years of age (z score and development quotient), mean literacy at 5–11 years of age (z score) and mean literacy at 13–19 years of age (z score) when compared with no UNHS (very low-certainty evidence).

Adverse effects were not reported in the systematic review.

Maternal outcomes

Experience of postnatal care and cost were not reported in the systematic review.

Additional considerations

Evidence reviews indicated that infants with PBHL identified through UNHS have significantly earlier referral, diagnosis and treatment, and improve communication outcomes than those identified through means other than UNHS (131, 132).

A systematic review of 32 study populations in HICs (1 799 863 screened infants) found high sensitivity, specificity, positive and negative predictive values for AABR and OAE, used alone or in combination. Sensitivity and specificity ranged from 89% to 100% and from 92% to 100%, respectively, positive predictive values ranged from 2% to 84%, with all negative predictive values 100% (115).

Additional considerations

The systematic review of economic evaluations described above identified eleven modelling evaluations that concluded UNHS was cost-effective compared with no screening or selective screening in Australia, China, Chinese Taipei, Germany, Philippines, Spain, the United Kingdom and the USA (133).

One additional modelling evaluation published after the publication of the above-mentioned systematic review found that a two-stage screening protocol (OAE-AABR maternity) was cost-effective for implementation in Albania (137).

Table 3.55

Main resource requirements for universal newborn hearing screening (UNHS).

Additional considerations

Some studies have reported that risk factors for infant hearing loss or impairment include low maternal education (140), minority race (141) and living in poorer urban neighbourhoods (141). Low socioeconomic status has also shown to be related to non-participation in newborn hearing screening programmes (142).

Additional considerations

Several individual qualitative research studies exploring parental experiences of UNHS programmes indicate that parents may experience anxiety related to newborn hearing screening, often feel unprepared for the positive and/or inconclusive results of a newborn hearing test and may need additional support and information from knowledgeable, sensitive health workers (143–145). A cross-sectional observational study among 48 mothers in Nigeria reported poor awareness of newborn hearing screening. However, the majority of mothers (92%) expressed a willingness to accept hearing screening for their child. Willingness to accept screening was associated with socioeconomic status and maternal education (146).

Additional considerations

Implementation of selective hearing screening programmes (e.g. risk factor and opportunistic screening) requires training of health workers in the important risk factors for hearing loss and the behaviour of babies who have hearing loss. These programmes also require a personal level of awareness from busy health workers on a day-to-day basis.

A national evaluation of the UNHS programme in the USA from 2005 to 2006 (147) found that the screening programme was effective but barriers to follow-up including a lack of service-system capacity, lack of health workers knowledge and information gaps limited overall success in a number of states. Low follow-up presents a challenge to UNHS programmes, particularly in low- to middle-income settings.

Table 3.56

Summary of judgements: UNHS compared with no screening or selective screening (no UNHS).

Comparison: Universal screening for identification of neonatal hyperbilirubinaemia by TcB at discharge compared with clinical screening (visual inspection and/or assessment of risk factors), followed by TcB or TSB if required

Newborn/infant outcomes

Severe neonatal morbidity

Severe hyperbilirubinaemia

• Evidence from RCTs: Low-certainty evidence suggests universal screening by TcB for hyperbilirubinaemia may lead to a reduction in proportion of newborns with severe hyperbilirubinaemia when compared with clinical screening (1 trial, 1858 newborns; RR 0.27, 95% CI 0.08 to 0.97).
• Evidence from non-RCTs: Low-certainty evidence suggests universal screening by TcB for hyperbilirubinaemia may lead to a reduction in the proportion of newborns with severe hyperbilirubinaemia when compared with clinical screening (1 study, 358 086 newborns; RR 0.25, 95% CI 0.12 to 0.52).

Jaundice requiring exchange transfusion

• Evidence from RCTs: It is uncertain whether universal screening by TcB for hyperbilirubinaemia has any effect on the proportion of newborns with jaundice requiring exchange transfusion when compared with clinical screening (very low-certainty evidence).
• Evidence from non-RCTs: Low-certainty evidence suggests universal screening by TcB for hyperbilirubinaemia may reduce the proportion of newborns with jaundice requiring exchange transfusion when compared with clinical screening (1 study, 358 086 newborns; OR 0.28, 95% CI 0.19 to 0.42).

Kernicterus/BIND

• It is uncertain whether universal screening by TcB for hyperbilirubinaemia has any effect on the proportion of cases of BIND/kernicterus when compared with clinical screening (RCT; very low-certainty evidence).

Health service use

Readmission for jaundice

• Evidence from RCTs: Moderate-certainty evidence suggests universal screening by TcB for hyperbilirubinaemia probably reduces readmission for jaundice when compared with clinical screening (1 trial, 1858 newborns; OR 0.24, 95% CI 0.13 to 0.46).
• Evidence from non-RCTs: It is uncertain whether universal screening by TcB for hyperbilirubinaemia has any effect on readmission for jaundice when compared with clinical screening (very low-certainty evidence).

Neonatal mortality, neurodevelopment and adverse effects were not reported in the systematic review.

Maternal outcomes

Experience of postnatal care and cost were not reported in the systematic review.

Additional considerations

One before-and-after study in a well-baby nursery (28 908 newborns) identified as part of the systematic review above compared universal TcB screening (daily TcB in hospital and post discharge in the community) with clinical screening (visual inspection by a public health nurse). The study reported that universal TcB screening decreased severe hyperbilirubinaemia (OR 0.45, 95% CI 0.31 to 0.65) and readmission for jaundice (OR 0.91, 95% CI 0.81 to 1.04) in healthy newborns ≥ 35 weeks’ gestation, while the mean length of pre-discharge hospital stay was unchanged (40.8±22.3 hours in the universal TcB screening group compared with 40.3±21.5 hours in the visual inspection group; MD 0.5 higher, 95% CI 0 to 1 higher) (150).

There are concerns that TcB screening may overestimate TSB levels in newborns with dark skin colour/tone (151, 152), but evidence in this regard is conflicting (153). The same applies to factors such as gestational age, postnatal age and TSB levels.

Additional considerations

In a before-and-after study evaluating the implementation of universal TcB screening in a tertiary centre in Canada, McLean and colleagues estimated the cost per TcB screen to be Can$ 3.54 and Can$ 3.76 in hospital and community settings, respectively (154).

Table 3.57

Main resource requirements of universal screening for neonatal hyperbilirubinaemia by TcB.

Additional considerations

The authors of a qualitative study on parents’ decision-making in newborn screening (156) found that parents supported newborn screening for treatable disorders but suggested optional screening for other disorders. They also suggested that the variable influences on parents’ decision-making could provide critical perspectives and help screening programmes to address parents’ preferences and meet relevant information needs, if parents were included in the decision-making regarding screening policies.

Additional considerations

Indirect evidence from a qualitative evidence synthesis exploring provision and uptake of routine antenatal services (80) suggests the initial cost and maintenance of screening equipment as well as the lack of suitably trained health workers may be prohibitive factors in some resource-limited settings (high confidence in the evidence).

As TcBs are portable, easy to use and generate instantaneous results (157), universal screening with this method was considered probably feasible, where funding for capital outlay is available.

Table 3.58

Summary of judgements: Universal TcB compared with clinical screening.

Comparison: Universal screening of TSB before discharge compared with clinical screening (visual inspection and/or risk factor assessment)

Newborn/infant outcomes

Severe neonatal morbidity: It is uncertain whether universal pre-discharge TSB screening for neonatal hyperbilirubinaemia has any effect on the number of neonates with severe hyperbilirubinaemia or jaundice requiring exchange transfusion when compared with clinical screening.

Health service use: It is uncertain whether universal pre-discharge TSB screening for neonatal hyperbilirubinaemia has any effect on readmissions for jaundice when compared with clinical screening.

Neonatal mortality, neurodevelopment and adverse effects of screening were not reported in the systematic review.

Maternal outcomes

Experience of postnatal care and cost were not reported in the systematic review.

Additional considerations

Estimated costs per TSB screen performed in health facilities in HICs varied. McLean and colleagues estimated the cost per TSB screen to be Can$ 15.82 in hospital settings, and Can$ 50.21 and Can$ 65.03 in urban and rural community settings, respectively (154). No information on the costs of TSB screening in LMICs was identified.

A 2012 modelling study evaluated the incremental cost-effectiveness of a system-based approach involving universal TSB screening and the management of neonatal jaundice and prevention of kernicterus in infants > 35 weeks’ gestation. It considered the traditional practice of visual inspection and selective TSB screening, and found that increased costs associated with universal TSB screening were partially offset by reduced emergency room visits, readmissions, and cases of kernicterus (158).

Equity

No direct evidence was identified on the impact on health equity of universal screening for neonatal hyperbilirubinaemia by TSB before discharge from health facilities among term newborns. Universal TSB screening of newborns could improve detection of neonatal hyperbilirubinaemia and prompt early intervention to prevent severe hyperbilirubinaemia in LMICs, where jaundice-related death and disability is more prevalent (155), but more evidence is needed. The PICO question guiding this evidence summary was expressly concerned with universal TSB screening before discharge from health facilities. Therefore, given pre-discharge TSB screening (and follow-up testing and management, where required) would be equally accessible to all facility-born newborns, it is anticipated that this intervention would probably have no impact on health equity.

Table 3.59

Main resource requirements for universal screening for neonatal hyperbilirubinaemia by TSB.

Additional considerations

TSB screening requires a blood draw via heel prick, which is an invasive, painful procedure for newborns that may not be acceptable to parents. In settings where TSB can be included in a routine metabolic screen, thus not requiring an additional standalone heel prick, parents may find universal TSB more acceptable.

Additional considerations

TSB is not available in all facilities, and capacity to procure TSB analysis via external laboratories varies across facilities and settings. Where TSB can be included in a routine metabolic screen, it may be more feasible.

Table 3.60

Summary of judgements: Universal TSB compared with clinical screening.

Comparison 1: Delayed first bath (after 24 hours) compared with early first bath (at or before 24 hours)

Newborn/infant outcomes

Neonatal/infant mortality: Low-certainty evidence suggests a delayed first bath (after 24 hours) may reduce infant mortality (all-cause) when compared with an early bath (at or before 24 hours) (1 study, 789 newborns; RR 0.46, 95% CI 0.28 to 0.76).

Short-term neonatal morbidity: Low-certainty evidence suggests that a delayed first bath (after 24 hours) may reduce neonatal hypothermia when compared with an early bath (at or before 24 hours) (1 study, 660 newborns; RR 0.50, 95% CI 0.28 to 0.88).

Breastfeeding status: It is uncertain whether a delayed first bath (after 24 hours) has any effect on exclusive breastfeeding at discharge when compared with an early bath (at or before 24 hours) (very low-certainty evidence).

Severe neonatal/infant morbidity was not reported in the systematic review.

Maternal outcomes

Experience of postnatal care was not reported in the systematic review.

Comparison 2: Delayed first bath (after 6 hours; i.e. at or after 9, 12 or 24 hours) compared with early first bath (at or before 6 hours)

Newborn/infant outcomes

Neonatal/infant mortality: It is uncertain whether a delayed first bath (after 6 hours) has any effect on neonatal mortality when compared with an early bath (at or before 6 hours) (very low-certainty evidence).

Short-term neonatal morbidity: Low-certainty evidence suggests a delayed first bath (after 6 hours; that is, at or after 9, 12 or 24 hours) may reduce neonatal hypothermia when compared with an early bath (at or before 6 hours) (4 studies, 2711 newborns; OR 0.47, 95% CI 0.36 to 0.61). Low-certainty evidence suggests a delayed first bath (after 6 hours; that is, after 12 or 24 hours) may reduce neonatal hypoglycaemia when compared with an early bath (at or before 6 hours) (3 studies, 2775 newborns; RR 0.39, 95% CI 0.23 to 0.66).

Breastfeeding status: Low-certainty evidence suggests a delayed first bath (after 6 hours; that is, after 9, 12 or 24 hours) may increase exclusive breastfeeding at discharge when compared with an early bath (at or before 6 hours) (6 studies, 6768 newborns; OR 1.20, 95% CI 1.08 to 1.34).

Severe neonatal/infant morbidity was not reported in the systematic review.

Maternal outcomes

Experience of postnatal care was not reported in the systematic review.

Equity

A before-and-after evaluation of Malawi’s Community-Based Maternal and Newborn Care programme using household surveys indicated increases in the coverage of delayed bathing (defined as first bath at 6 or more hours after birth) at endline compared with baseline across wealth quartiles. A small but statistically significant increase in equity was observed between baseline and endline for delayed bathing (171). Another community-based newborn care package in Nepal demonstrated an increase in coverage of delayed bathing (defined as first bath at 6 or more hours after birth) across wealth quartiles at endline compared with baseline, though there was no statistically significant increase in equity for this specific component of the care package (172).

Table 3.61

Main resource requirements for delayed first bath compared with early first bath.

Interventions that improve newborn and infant outcomes, including rates of breastfeeding, could assist to address health equity. Delaying the timing of first neonatal bath is a simple intervention with no additional ongoing cost implications for facilities or families. Provided the necessary training and support is available to alter current practice, this intervention would probably increase health equity.

Additional considerations

In one study included in the systematic review (170) assessing the effect of delaying newborn bathing for 24 hours, nurses felt more supported by their peers to delay the first bath by 24 hours during post-implementation surveys than before the intervention (173). However, the acceptability among families of delayed bathing may vary across populations, particularly where early bathing is culturally normative (174).

Additional considerations

In one study included in the systematic review (173) assessing the effect of delaying newborn bathing for 24 hours, more nurses reported feeling comfortable identifying the benefits of delayed bathing, its contraindications, and encouraging families and their nursing peers to delay the first bath by 24 hours during post-implementation surveys than before the intervention. There was no increase in workload.

Table 3.62

Summary of judgements: Delayed first bath compared with early first bath.

Comparison: Topical emollients compared with no intervention or skin care without emollients

Newborn/infant outcomes

Short-term neonatal/infant morbidity: Low-certainty evidence suggests skin care with topical emollients may have little or no effect on atopic dermatitis in term, healthy newborns when compared with no intervention or skin care without emollients (2 trials, 1408 newborns; RR 1.29, 95% CI 0.96 to 1.72). It is uncertain whether skin care with emollients has any effect on food allergies, allergic sensitization to food allergens, allergic sensitization to inhalation allergens, dryness or skin problems in healthy newborns when compared with no intervention or skin care without emollients (very low-certainty evidence).

Adverse effects: Only two trials reported provided information on adverse effects. One trial (115 newborns) reported that oils may impede the development of lamellar lipid structures of the permeability barrier from birth. The other trial (2397 newborns) reported one slippage of the baby in the emollient group compared with none in the control.

Maternal outcomes

Maternal functioning/well-being was not reported in the systematic review.

Additional considerations

The systematic review included seven trials (894 newborns, one trial did not report the number of participants) including newborns at risk of atopic dermatitis, defined in most studies as having at least one first-degree relative with parent-reported or physician-diagnosed eczema, allergic rhinitis or asthma. The results suggest that the use of emollients reduces the risk of atopic dermatitis with little or no effect on food allergy, allergic sensitization with food allergens, allergic sensitization with inhaled allergens, skin dryness and skin problems. In one trial (1394 newborns), parents reported an increase in doctor-diagnosed skin infections. There was no difference in infant slippages within 1 hour of applying emollients.

Additional considerations

One trial (176) evaluating emollient application during the first year for preventing atopic eczema in high-risk infants will report cost-effectiveness and cost-utility at 24 months.

Feasibility

A qualitative evidence synthesis of women’s experiences of postnatal care found no direct evidence relating to women’s views on the feasibility of using emollients for skin care in term newborns (28). Indirect evidence from the same review indicates some women in LMICs may be less likely to use these products if they perceive that health facilities lack the resources to offer advice and support or if they believe that utilization will incur unnecessary additional costs (moderate confidence in the evidence).

Table 3.63

Main resource requirements for topical emollients for skin care in term, healthy newborns.

A qualitative evidence synthesis of health workers’ experiences of postnatal care found no direct evidence relating to views on the feasibility of using emollients for skin care in term newborns (29). However, indirect evidence suggests that lack of personnel, resources and training may limit the provision of information and counselling on the use of emollients for skin care in term newborns during the postnatal period (moderate confidence in the evidence).

Additional considerations

A study included in the systematic review on effectiveness evaluated whether emollient use from birth is feasible for reducing the atopic dermatitis in high-risk neonates. All participating families found the intervention acceptable, and the majority reported applying emollients at least five days per week at six months (162).

Emollient use is a simple intervention, but application to an infant’s whole body daily or several times per week, across an extended period of time, may be demanding for some families.

Table 3.64

Summary of judgements: Topical emollients compared with no emollients.

Comparison: Routine application of chlorhexidine to the umbilical cord stump compared with dry cord care or usual care

Newborn/infant outcomes

Neonatal mortality: Moderate-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump probably makes little or no difference to neonatal mortality when compared with dry cord care or usual care (5 trials, 136 829 newborns; OR 0.90, 95% CI 0.78 to 1.04).

Subgroup analysis by the mortality rate reported in the trial is as follows.

• It is uncertain whether routine application of chlorhexidine to the umbilical cord stump has any effect on neonatal mortality in settings with neonatal mortality rates ≥ 30% when compared with dry cord care or usual care (very low-certainty evidence).
• High-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump has little or no effect on neonatal mortality in settings with neonatal mortality rates < 30% when compared with dry cord care or usual care (2 trials, 74 762 newborns; OR 0.99, 95% CI 0.79 to 1.25).

Subgroup analysis by place of birth is as follows.

• It is uncertain whether routine application of chlorhexidine to the umbilical cord stump has any effect on neonatal mortality in babies born at home when compared with dry cord care or usual care (very low-certainty evidence).
• Moderate-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump probably makes little or no difference to neonatal mortality in babies born in facilities when compared with dry cord care or usual care (5 trials, 50 644 newborns; OR 0.95, 95% CI 0.81 to 1.10).

Subgroup analysis by non-hygienic applications is as follows.

• Moderate-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump probably reduces neonatal mortality when compared with usual care that includes nonhygienic applications (5 trials, 27 817 newborns; OR 0.63, 95% CI 0.50 to 0.79).
• Moderate-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump probably makes little or no difference to neonatal mortality when compared with dry cord care or cord care that does not include nonhygienic applications (5 trials, 136 320 newborns; OR 0.89, 95% CI 0.77 to 1.03).

Neonatal mortality after 24 hours of age: Moderate-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump probably makes little or no difference to mortality in infants over 24 hours of age when compared with dry cord care or usual care (5 trials, 135 237 newborns; OR 0.91, 95% CI 0.82 to 1.02).

Severe neonatal/infant morbidity:¹² Moderate-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump probably reduces the risk of moderate omphalitis when compared with dry cord care or usual care (5 trials, 137 942 newborns; OR 0.77, 95% CI 0.71 to 0.83). Low-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump may reduce the risk of severe omphalitis when compared with dry cord care or usual care (5 trials, 137 942 newborns; OR 0.55, 95% CI 0.39 to 0.76). Low-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump may have little or no effect on any possible serious bacterial infection (PSBI) when compared with dry cord care or usual care (5 trials, 137 942 newborns; OR 0.91, 95% CI 0.76 to 1.10). Low-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump may have little or no effect on more specific PSBI when compared with dry cord care or usual care (5 trials, 137 942 newborns; OR 0.91, 95% CI 0.75 to 1.11). Moderate-certainty evidence suggests routine application of chlorhexidine to the umbilical cord stump probably makes little or no difference to more severe PSBI (5 trials, 137 942 newborns; OR 0.93, 95% CI 0.83 to 1.10).

The IPD meta-analysis did not report on health service use. Only narrative information on the adverse effects of chlorhexidine was available, which is summarized below under Additional considerations.

Maternal outcomes

The IPD meta-analysis did not report on experience of postnatal care.

Additional considerations

The five studies were reviewed by the IPD authors for data on adverse effects. One study did not state whether adverse effects were assessed. One study reported eight cases of mild local skin irritation and one case where the chlorhexidine was accidently applied to the conjunctiva, resulting in mild ocular irritation. No newborns in the other three trials were reported to have adverse effects.

In 2019, the WHO released an alert regarding serious eye injury as a result of chlorhexidine misadministration, with reports of chlorhexidine being mistakenly applied to the eye (as eye drops or ointment) (178). The alert urges all stakeholders involved in umbilical cord care to take steps to ensure correct use and administration of chlorhexidine. Reproductive health programmes and regulators were instructed to ensure clear and unique labelling of chlorhexidine products, and to provide parents and other caregivers with detailed, culturally appropriate written materials and counselling on chlorhexidine use (178).

Two hospital trials were included in the 2014 WHO recommendations on postnatal care of the mother and newborn (15) but were not included in the current IPD analysis as individual patient data were not available. Both trials examined infants for omphalitis and reported similar effects to the IPD analysis (890 newborns, RR 0.48, 95% CI 0.28 to 0.84). One trial examined infants for neonatal mortality and reported a large, non-significant reduction (120 newborns, RR 0.11, 95% CI 0.01 to 2.04).

Resources

No economic evaluations of the application of chlorhexidine to the umbilical cord stump were identified.

Table 3.65

Main resource requirements for the application of chlorhexidine to the umbilical cord stump.

Additional considerations

A 2010 household survey in rural Bangladesh found that most households were not willing to pay for chlorhexidine at the fixed price point, but indicated a willingness and capacity to borrow money to meet any shortfalls (179). Another study in Bangladesh (180) found that if the unit price of multi-dose chlorhexidine was any higher than 25 Bangladesh Taka (US$ 0.35), at least some households would need to borrow money in order to pay for it, thus potentially requiring subsidization (179).

Additional considerations

The WHO Model List of Essential Medicines for Children includes Chlorhexidine “solution or gel: 7.1% (digluconate) delivering 4% chlorhexidine (for umbilical cord care)” (181).

Table 3.66

Summary of judgements: Routine application of chlorhexidine to the umbilical cord stump compared with dry or usual cord care.

Comparison: Supine (back) sleep position compared with non-supine (prone or side) sleep position

Newborn/infant outcomes

Infant mortality: It is uncertain whether sleeping in a supine position has any effect on deaths due to SIDS in infants < 1 year of age when compared with sleeping in a non-supine (prone or side) position (very low-certainty evidence). Low-certainty evidence suggests that sleeping in a supine position may decrease SUDI when compared with sleeping in a non-supine (prone or side) position (1 study, 384 infants; OR 0.39, 95% CI 0.23 to 0.65).

Severe neonatal/infant morbidity: It is uncertain whether sleeping in a supine position has any effect on unexplained SIDS or severe ALTE in the neonatal period when compared with sleeping in a non-supine (prone or side) position (very low-certainty evidence).

Neurodevelopment: Compared with sleeping in a prone position, moderate-certainty evidence suggests sleeping in a supine position probably worsens gross motor development at 6 months of age, measured as odds of being 0.5 SD below the mean on the gross motor scale of the Denver Developmental Screening Test (DDST) (1 study, 2097 infants; OR 1.67, 95% CI 1.22 to 2.27). Compared with sleeping in a side position, moderate-certainty evidence suggests sleeping in a supine position probably has little or no effect on gross motor development at 6 months of age, measured as odds of being 0.5 SD below the mean on the gross motor scale of the DDST (1 study, 8012 infants; OR 1.02, 95% CI 0.91 to 1.15). Compared with sleeping in a prone position, low-certainty evidence suggests sleeping in a supine position may have little or no effect on gross motor development at 18 months of age, measured as odds of being 0.5 SD below the mean on the gross motor scale of the DDST (1 study, 1919 newborns; OR 1.16, 95% CI 0.96 to 1.43). Compared with sleeping in a side position, low-certainty evidence suggests sleeping in a supine position may have little or no effect on gross motor development at 18 months of age, measured as odds of being 0.5 SD below the mean on the gross motor scale of the DDST (1 study, 7503 newborns; OR 1.12, 95% CI 0.86 to 1.45).

Health service use: It is uncertain whether sleeping in a supine position has any effect on hospital admissions related to ALTE within 6 months of age¹³ when compared with sleeping in a non-supine (prone or side) position (very low-certainty evidence).

Adverse effects: Low-certainty evidence suggests sleeping in a supine position may increase positional plagiocephaly within 28 weeks of age¹⁴ when compared with sleeping in a non-supine position (prone or side) (2 studies, 471 newborns; OR 6.53, 95% CI 3.39 to 12.57).

Neonatal mortality was not reported in the included studies.

Maternal outcomes

Experience of postnatal care was not reported in the included studies.

Additional considerations

An analysis of trends in post-neonatal mortality and SIDS rates in Australia, Great Britain, the Netherlands, New Zealand, Norway, Sweden and the USA between 1980 and 1992 found that countries that experienced a rapid decline in prone sleeping also had reductions in SIDS rates of approximately 50% (182). There were no significant changes in the proportion of parents who smoked cigarettes or in breastfeeding rates during this time. There was no apparent increase in adverse events such as deaths due to aspiration or ALTE, though these data were considered preliminary.

The Back to Sleep campaign, a large public health programme in the USA aiming to promote the supine sleeping position, was launched in 1994. This campaign remains ongoing (though has now been renamed as the Safe to Sleep campaign).¹⁵ Significant increases in the supine sleep position from 13% to approximately 76% from 1992 to 2006, and a drop in the USA SIDS rate of about 50% over the same period, has subsequently been reported. The most dramatic declines occurred in the years immediately after the first non-prone sleep position recommendations (183, 184). A study evaluating the impact of the Back to Sleep campaign from 1990 to 2012 in Colorado, USA, also reported significant decreases in SIDS incidence from 1.99/1000 live births in the pre-Back to Sleep era (1990-1993) to 0.57/1000 live births in the post-Back to Sleep era (1997–2012) (P ≤ 0.001 for the trend) (185).

Values

See Box 3.10 in section 3.B.2: Preventive measures.

Table 3.67

Main resource requirements for supine (back) sleep position.

Additional considerations

The prevalence of SIDS is higher among socially and economically disadvantaged families (186). There are also clear disparities in newborn sleeping practices according to racial, demographic, economic and other factors. For example, supine sleep positioning appears less prevalent among Hispanic and non-Hispanic black populations compared with non-Hispanic white populations (187). Other studies have shown mothers with low levels of education are more likely to place their infant in a non-supine sleep position than mothers with higher levels of education (188, 189). Lower caregiver income has also been associated with decreased likelihood of awareness of infant sleep position recommendations (190).

Additional considerations

A qualitative evidence synthesis exploring decision-making for infant sleep environment among at-risk families (191) identified key issues that were prevalent among relatively deprived populations living in HICs. Parents were reluctant to accept health worker guidance on infant sleeping positions if they felt the advice was counter-intuitive or compromised their own experience (e.g. that placing infants in non-supine positions aid comfort, help with breathing or reduce the potential for choking). Parents wanted information and advice explained to them along with supporting evidence, rather than being told what to do in a didactic manner.

Additional considerations

A qualitative synthesis exploring decision-making for infant sleep environment among at-risk families (191) identified several key issues prevalent among relatively deprived populations living in HICs. Findings indicate that parents in these communities may not trust advice on sleeping positions given by health workers, especially where it conflicts with information provided by trusted family members or community networks.

Table 3.68

Summary of judgements: Supine (back) sleep position compared with non-supine (prone or side) sleep position.

Comparison: Vitamin A supplementation compared with placebo or no vitamin A supplementation (Campbell systematic review)

Newborn/infant outcomes

Neonatal/infant mortality: High-certainty evidence shows early vitamin A supplementation has little or no effect on all-cause neonatal mortality (0–28 days after birth) when compared with placebo (6 trials, 126 548 infants; RR 0.99, 95% CI 0.90 to 1.08). Moderate-certainty evidence suggests early vitamin A supplementation probably has little or no effect on all-cause infant mortality at 6 months of age when compared with placebo (12 trials, 154 940 infants; RR 0.98, 95% CI 0.89 to 1.07). High certainty evidence suggests that early vitamin A supplementation has little or no effect on all-cause infant mortality at 12 months of age when compared with placebo (8 trials, 118 376 infants; RR 1.04, 95% CI 0.94 to 1.14).

Adverse effects: Moderate-certainty evidence suggests vitamin A supplementation probably increases infant bulging fontanelle (within three days of dosing) when compared with placebo (6 trials, 100 256 infants; RR 1.53, 95% CI 1.12 to 2.09). High certainty evidence shows vitamin A supplementation has little or no effect on infants vomiting (within three days of dosing) when compared with placebo (5 trials, 99 582 infants; RR 1.00, 95% CI 0.93 to 1.07).

Severe neonatal morbidity was not reported in the included trials.

Maternal outcomes

Experience of postnatal care was not reported in the systematic review.

Comparison: Vitamin A supplementation compared with placebo or no vitamin A supplementation (IPD meta-analysis)¹⁶

Neonatal/infant mortality: Newborn vitamin A supplementation was associated with a variable effect from an 11% decrease to a 6% increase in the risk of death up to 6 months of age (11 trials; RR 0.97, 95% CI 0.89 to 1.06) and a variable effect from a 7% decrease to an 8% increase of death up to 12 months of age (10 trials; RR 1.00, 95% CI 0.93 to 1.08) when compared with placebo.

Univariate meta-regression and meta-analyses by study level characteristics

Meta-regression identified five variables as significantly associated with the effect of newborn vitamin A supplementation on mortality at six months, as presented below. Meta-analyses by study-level characteristics were subsequently conducted for these variables.

Geographic region: Until 6 months of age, newborn vitamin A supplementation was associated with a 13% lower risk of death in Asian countries (5 trials; RR 0.87, 95% CI 0.77 to 0.98), but in African countries the risk of death includes a variable effect from a 2% reduction to a 15% increase (6 trials; RR 1.06, 95% CI 0.98 to 1.15). Until 12 months of age, newborn vitamin A supplementation was associated with a variable effect from a 20% reduction to a 3% increase in the risk of death in Asian countries (4 trials; RR 0.91, 95% CI 0.80 to 1.03), and a variable effect from no effect to a 15% increase in African countries (6 trials; RR 1.07, 95% CI 1.00 to 1.15).

Maternal vitamin A deficiency: Until 6 months of age, and in study populations where the prevalence of maternal vitamin A deficiency was moderate or severe, newborn vitamin A supplementation was associated with a 13% lower risk of death (3 trials; RR 0.87, 95% CI 0.80 to 0.94). In study populations where there was no or mild maternal vitamin A deficiency, the risk of death includes a variable effect, from a 4% lower to a 15% higher risk of death (7 trials; RR 1.05, 95% CI 0.96 to 1.15). Until 12 months of age, and in study populations where the prevalence of maternal vitamin A deficiency was moderate or severe, newborn vitamin A supplementation was associated with a variable effect, from a 17% lower risk to no effect on the risk of death (2 trials; RR 0.91, 95% CI 0.83 to 1.00). In study populations where there was no or mild maternal vitamin A deficiency, the risk of death includes a variable effect, from a 2% lower risk to a 15% higher risk (7 trials; RR 1.06, 95% CI 0.98 to 1.15).

Early infant mortality: Newborn vitamin A supplementation was associated with a 9% lower risk of death up to 6 months of age in study populations where 6-month mortality in the control group was ≥ 30 per 1000 live births (6 trials; RR 0.91, 95% CI 0.85 to 0.98), but includes a variable effect from a 5% lower risk to a 24% higher risk of death in populations where 6-month mortality in the control group was under 30/1000 (5 trials; RR 1.08, 95% CI 0.95 to 1.24).

Ratio of 6-month to 12-month mortality in the control group: Newborn vitamin A supplementation was associated with a variable effect from a 16% lower to a 1% higher risk of death up to 6 months of age in study populations where 75% or more of infant mortality occurred in the first 6 months (6 trials; RR 0.92, 95% CI 0.84 to 1.01), but was associated with a variable effect from no effect to a 22% higher risk of mortality in populations where less than 75% of infant mortality occurred up to 6 months of age (4 trials; RR 1.11, 95% CI 1.00 to 1.22).

Maternal education: Newborn vitamin A supplementation was associated with a 12% lower risk of death up to 6 months of age in populations where ³ 32% of mothers had never been to school (4 trials; RR 0.88, 95% CI 0.80 to 0.96), but was associated with a variable effect from an 8% lower to an 18% higher risk of death in study populations where < 32% of mothers had never been to school (5 trials; RR 1.04, 95% CI 0.92 to 1.18).

Subgroup analysis by neonatal risk status (high risk or low risk)

Vitamin A given to < 2500 g newborns: Vitamin A supplementation in newborns whose birthweight was < 2500 g was associated with a variable effect from an 11% decrease to a 5% increase in the risk of death up to 6 months of age (8 trials; RR 0.97, 95% CI 0.89 to 1.05) and a variable effect from an 8% decrease to an 8% increase in the risk of death up to 12 months of age (7 trials; RR 0.99, 95% CI 0.92 to 1.08) when compared with placebo.

Vitamin A given to ≥ 2500 g newborns: Vitamin A supplementation in newborns whose birthweight was ≥ 2500 g was associated with a variable effect from an 11% decrease to a 4% increase in the risk of death up to 6 months of age (8 trials; RR 0.96, 95% CI 0.89 to 1.04) and a variable effect from a 7% decrease to a 7% increase in the risk of death up to 12 months of age (7 trials; RR 1.00, 95% CI 0.93 to 1.07) when compared with placebo.

Subgroup analysis by maternal risk of vitamin A deficiency

Vitamin A given to newborns of mothers with night blindness during pregnancy: Vitamin A supplementation in newborns whose mothers had night blindness during pregnancy was associated with a variable effect from a 35% decrease to a 33% increase in the risk of death up to 6 months of age (3 trials; RR 0.93, 95% CI 0.65 to 1.33) and a variable effect from a 36% decrease to a 37% increase of death up to 12 months of age (2 trials; RR 0.94, 95% CI 0.64 to 1.37) when compared with placebo.

Vitamin A given to newborns of mothers without night blindness during pregnancy: Vitamin A supplementation in newborns whose mothers did not had night blinding during pregnancy was associated with a 14% decrease in the risk of death up to 6 months of age (3 trials; RR 0.86, 95% CI 0.77 to 0.96) but a variable effect from a 23% decrease to no effect in the risk of death up to 12 months of age (2 trials; RR 0.88, 95% CI 0.78 to 1.00) when compared with placebo.

Subgroup analysis by initiation of breastfeeding

Vitamin A given to newborns initiating breastfeeding during the first hour after birth: Vitamin A supplementation in newborns who initiated breastfeeding during the first hour after birth was associated with a variable effect from a 6% decrease to a 14% increase in the risk of death up to 6 months of age (6 trials; RR 1.03, 95% CI 0.94 to 1.14) and a variable effect from a 5% decrease to a 12% increase in the risk of death up to 12 months of age (6 trials; RR 1.03, 95% CI 0.95 to 1.12), when compared with placebo.

Vitamin A given to newborns initiating breastfeeding 2–23 hours after birth: Vitamin A supplementation in newborns who initiated breastfeeding 2–23 hours after birth was associated with a variable effect from a 13% reduction to a 3% increase in the risk of death up to 6 months of age (6 trials; RR 0.94, 95% CI 0.87 to 1.03) and a variable effect from a 10% decrease to a 5% increase in the risk of death up to 12 months of age (6 trials; RR 0.97, 95% CI 0.90 to 1.05), when compared with placebo.

Vitamin A given to newborns initiating breastfeeding ≥ 24 hours after birth: Newborn vitamin A supplementation in newborns who initiated breastfeeding ≥ 24 hours after birth was associated with a variable effect from a 26% decrease to a 13% increase in the risk of death up to 6 months of age (6 trials; RR 0.92, 95% CI 0.74 to 1.13) and a variable effect from a 26% decrease to an 8% increase in the risk of death up to 12 months of age (6 trials; RR 0.90, 95% CI 0.74 to 1.08), when compared with placebo.

Subgroup analysis by newborn sex

Vitamin A given to male newborns: Vitamin A supplementation in male newborns was associated with a variable effect from an 8% decrease to an 8% increase in the risk of death up to 6 months of age (11 trials; RR 0.99, 95% CI 0.92 to 1.08) and a variable effect from a 7% decrease to a 7% increase in the risk of death up to 12 months of age (10 trials; RR 1.00, 95% CI 0.93 to 1.07), when compared with placebo.

Vitamin A given to female newborns: Newborn vitamin A supplementation in female newborns was associated with a variable effect from a 14% decrease to a 1% increase in the risk of death up to 6 months of age (11 trials; RR 0.93, 95% CI 0.86 to 1.01) and a variable effect from an 8% decrease to a 6% increase in the risk of death up to 12 months of age (10 trials; RR 1.01, 95% CI 0.92 to 1.06), when compared with placebo.

Additional considerations

The Campbell review reported non-pooled results on long term neurodevelopment outcomes. One trial (2067 infants) (206) suggested neonatal vitamin A supplementation had no adverse effect on development (assessed using Bayley Scales of Infant Development at 3 years of age, having had vitamin A supplementation as neonates) irrespective of the presence or absence of bulging fontanelle (assessed by palpation of the anterior fontanelle), or any other signs or symptoms (e.g. fever, irritability, vomiting or diarrhoea) or an increase in intracranial pressure, as reflected by the resistive index. Neonatal vitamin A supplementation had a positive effect on all developmental scores. Another trial (15 937 infants) (207) found no evidence of a difference on neurodevelopment (intelligence, memory and motor function) at eight years post vitamin A supplementation in neonates or pregnant women; however, when the neonates and their mothers were both supplemented with vitamin A versus placebo, it increased their performance in reading, spelling and maths calculations.

Additional considerations

In general, health workers, policy-makers and parents, caregivers and family members in all settings are likely to place a high value on the survival of infants and young children and on safe interventions that lead to improved survival without causing morbidity.

Additional considerations

Operational research may be needed to determine the resources required based on the country or regional contexts within a country, such as differences between and within populations, urban and rural settings, and health systems, particularly the delivery of quality maternal and newborn care.

Table 3.69

Main resource requirements for neonatal vitamin A supplementation.

Additional considerations

It is important to assess the availability of subnational data in order to target and reduce inequities within countries and, when available, to use the disaggregated data to identify areas in need of programme availability, strengthening and support, as well as areas of high coverage, which may offer important lessons, insights and good practices.

Additional considerations

From the NeoVita trials in Ghana, India and the United Republic of Tanzania (208–210), neonatal vitamin A supplementation has been accepted for research purposes by families and health workers. However, in the Bangladesh mechanistic study, it was reported that 11% (72/636) of pregnant women eligible for the study refused participation, not wishing to give their newborns supplements (211).

In a feasibility study conducted in Bangladesh and Nepal (212), mothers viewed neonatal vitamin A supplementation favourably with few reports of negative experiences. The negative experiences were largely self-limiting and not clearly attributable to the intervention. Health workers viewed the intervention favourably.

The potential for benefit in some contexts and the potential for harm in other contexts may lead to differences in acceptability among various population groups. If restricted to specific settings in which the intervention has shown significant benefit, the intervention would likely be acceptable.

Additional considerations

The pooled analysis of the NeoVita trials suggests the inclusion of neonatal vitamin A dosing in the interventions that can be implemented in the immediate postnatal period and the first few days after birth is feasible and, potentially, cost-effective. Data from the published trials used in the pooled analysis suggest it is possible for vitamin A supplementation to be administered by health workers in community and hospital settings. In India, approximately 45% of births took place in the home, whereas in Ghana and the United Republic of Tanzania, 76–87% of births took place in a health facility. Pilot data from Nepal and Bangladesh also indicate that delivering neonatal vitamin A supplementation is feasible (212).

Vitamin A (retinol) is listed in the WHO Model List of Essential Medicines for Children (181) as oral oily solution, tablets and water-miscible injection. Some vitamin A supplements need to be stored in cool conditions (e.g. below 25 °C) and some require refrigeration once opened.

Table 3.70

Summary of judgements: Neonatal vitamin A supplementation compared with placebo or no supplementation.

Comparison: Vitamin D supplementation for breastfed, term infants compared with placebo or no supplementation

Newborn/infant outcomes

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggests that infants receiving vitamin D supplementation may have a lower risk of vitamin D insufficiency (plasma/serum 25-hydroxyvitamin D [25(OH)D] concentrations < 50 nmol/L) (4 trials, 274 infants; RR 0.57, 95% CI 0.41 to 0.80) when compared with infants not receiving vitamin D supplementation or receiving placebo. Low-certainty evidence suggests that vitamin D supplementation may increase plasma/serum 25(OH)D concentrations at latest time reported up to 6 months of age (6 trials, 334 infants; MD 22.63 nmol/L higher, 95% CI 17.05 higher to 28.21 higher) when compared with no supplementation or receiving placebo. It is uncertain whether vitamin D supplementation affects vitamin D deficiency (25(OH)D concentrations < 30 nmol/L), nutritional rickets (biochemical), weight, length, head circumference at 6 months of age, or bone mineral content at the end of intervention (very low-certainty evidence).

Adverse effects: It is uncertain whether vitamin D supplementation causes adverse effects (hypercalcaemia or other) when compared with no vitamin D supplementation or placebo (very low-certainty evidence).

Neonatal mortality and severe neonatal morbidity were not reported in the systematic review.

Maternal outcomes

Experience of postnatal care was not reported in the systematic review.

Subgroup analysis by neonatal risk status (high risk or low risk)

Vitamin D supplementation given to high-risk infants compared with no vitamin D supplementation or placebo

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggests that vitamin D supplementation among high-risk infants may reduce vitamin D insufficiency (plasma/serum 25(OH)D concentrations < 50 nmol/L) (3 trials, 134 infants; RR 0.65, 95% CI 0.46 to 0.94) when compared with no vitamin D supplementation or placebo. Low-certainty evidence suggests that vitamin D supplementation among high-risk infants may increase plasma/serum 25(OH)D concentrations (nmol/L) at latest time reported (up to 6 months of age; 3 trials, 134 infants; MD 18.24 nmol/L higher, 95% CI 9.39 higher to 27.09 higher) when compared with no vitamin D supplementation or placebo. It is uncertain whether vitamin D supplementation in high risk infants affects vitamin D deficiency (plasma/serum 25(OH)D < 30 nmol/L) or nutritional rickets (biochemical) when compared with no vitamin D supplementation or placebo (very low-certainty evidence).

Comparison: Vitamin D supplementation given to low-risk infants compared with no vitamin D supplementation or placebo

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggests that vitamin D supplementation among low-risk infants may reduce vitamin D insufficiency (plasma/serum 25(OH)D concentrations < 50 nmol/L) (1 trial, 140 infants; RR 0.19, 95% CI 0.07 to 0.53) when compared with no vitamin D supplementation or placebo. Low-certainty evidence suggests that vitamin D supplementation among low-risk infants may increase plasma/serum 25(OH)D levels (nmol/L) at latest the point reported up to 6 months of age (3 trials, 200 infants; MD 25.53 higher, 95% CI 18.34 higher to 32.72 higher) when compared with no vitamin D supplementation or placebo. It is uncertain whether vitamin D supplementation in low-risk infants affects the risk of nutritional rickets (biochemical; vitamin D2 200 IU/day from birth to 6 months of age) when compared with no vitamin D supplementation or placebo (very low-certainty evidence). Low-certainty evidence suggests that vitamin D supplementation among low-risk infants (D2 400 IU/day from birth to 3 months of age) may improve baby bone mineral content at the end of intervention when compared with placebo or no treatment (1 trial, 18 infants; MD 15 higher, 95% CI 6.68 higher to 23.32 higher). Low-certainty evidence suggests that vitamin D supplementation among low-risk infants (D2 400 IU/day from birth to 6 months of age) may reduce bone mineral content at the end of the intervention when compared with placebo or no treatment (1 trial, 38 infants; MD 11.5 lower, 95% CI 21.32 lower to 1.68 lower).

Subgroup analysis by different active form (vitamin D2 or D3)

Vitamin D supplementation given as vitamin D2 or D3 compared with placebo

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggests that infants receiving vitamin D3 supplementation may have lower risk of vitamin D insufficiency (25(OH)D < 50 nmol/L) when compared with no vitamin D supplementation or placebo (3 trials, 262 infants; RR 0.58, 95% CI 0.40 to 0.82). It is uncertain whether vitamin D2 supplementation affects vitamin D insufficiency (25(OH)D < 50 nmol/L) or vitamin D deficiency (25(OH)D < 30 nmol/L) when compared with no vitamin D supplementation or placebo. It is uncertain whether vitamin D3 supplementation affects vitamin D deficiency (25(OH)D < 30 nmol/L) when compared with no vitamin D supplementation or placebo.

Subgroup analysis by dosage (single oral dose of 50 000 IU or 400 IU daily)

Vitamin D supplementation as a daily oral dose of 400 IU compared with placebo

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggests that infants receiving vitamin D supplementation as a daily oral dose of 400 IU may have lower risk of vitamin D insufficiency (25(OH)D < 50 nmol/L) when compared with placebo (3 trials, 253 infants; RR 0.56, 95% CI 0.39 to 0.81). It is uncertain whether vitamin D supplementation as a daily oral dose of 400 IU affects vitamin D deficiency (25(OH)D < 30 nmol/L) when compared with placebo.

Vitamin D supplementation as a single oral dose of 50 000 IU compared with placebo

Subclinical or clinical vitamin D deficiency: It is uncertain whether vitamin D supplementation as a single oral dose of 50 000 IU affects vitamin D insufficiency (25(OH)D < 50 nmol/L) or vitamin D deficiency (25(OH)D < 30 nmol/L) when compared with placebo.

Subgroup analysis by time of administration (from birth, from 1 month of age)

Vitamin D supplementation given from birth compared with placebo

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggests that infants receiving vitamin D supplementation from birth may have a reduced risk of vitamin D insufficiency (25(OH)D <50 nmol/L) when compared with placebo (3 trials, 134 infants; RR 0.65, 95% CI 0.46 to 0.94). It is uncertain whether vitamin D supplementation given from birth affects vitamin D deficiency (25(OH)D < 30 nmol/L) when compared with placebo.

Vitamin D supplementation given from 1 month of age compared with placebo

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggests that infants receiving vitamin D supplementation given from 1 month of age may have a reduced risk of vitamin D insufficiency (25(OH)D < 50 nmol/L) when compared with placebo (1 trial, 140 infants; RR 0.19, 95% CI 0.07 to 0.53).

Subgroup analysis by duration of supplementation (single, oral 50 000 IU at birth, 1-2 months or > 6 months)

Vitamin D supplementation given as a single, oral dose of 50 000 IU at birth compared with placebo

Subclinical or clinical vitamin D deficiency: It is uncertain whether vitamin D supplementation given at birth as a single, oral dose of 50 000 IU affects vitamin D insufficiency (25(OH)D < 50 nmol/L) or vitamin D deficiency (25(OH)D < 30 nmol/L) when compared with placebo.

Vitamin D supplementation given for 1–2 months after birth compared with placebo

Subclinical or clinical vitamin D deficiency: It is uncertain whether vitamin D supplementation given 1–2 months after birth affects vitamin D insufficiency (25(OH)D < 50 nmol/L) when compared with placebo.

Vitamin D supplementation given for > 6 months after birth compared with placebo

Subclinical or clinical vitamin D deficiency: Low-certainty evidence suggest that infants receiving vitamin D supplementation for more than six months after birth may have a reduced risk of vitamin D insufficiency (25(OH)D < 50 nmol/L) when compared with placebo (2 trials, 241 infants; RR 0.57, 95% CI 0.39 to 0.83). It is uncertain whether vitamin D supplementation given for more than six months after birth affects vitamin D deficiency (25(OH)D < 30 nmol/L) when compared with placebo.

Additional considerations

WHO recommends vitamin D supplementation in very low birthweight infants at a dose ranging from 400 IU to 1000 IU per day until 6 months of age (215).

The systematic review did not report the priority outcomes of neonatal morbidity or mortality. Only one of the included trials evaluated neonatal morbidity (216) and reported that infants in the placebo group were more likely to report diarrhoea and respiratory illnesses than infants supplemented with vitamin D (median 13.0; IQR 7.0–28.5; P < 0.05). When differences between groups were assessed separately for diarrhoea or respiratory illness, there was no statistically significant difference. Admission to hospital was needed for 22 infants, 11 in each of the vitamin D supplementation and placebo groups.

Additional considerations

A cost-effectiveness modelling study of the use of vitamin D supplementation in pregnant women and infants and children < 4 years of age in the United Kingdom, where rickets has an estimated annual incidence of 29.75 per 100 000 children < 4 years of age, found that vitamin D supplementation in dark skin tone populations was cost saving. In medium skin tone populations and light skin tone populations, the incremental cost-effectiveness ratio was £19 295 per QALY and £404 047 per QALY, respectively (217). Overall, supplementation was cost-saving in participants with a dark skin tone, cost-effective in participants with a medium skin tone, but not cost-effective in participants with a light skin tone.

Supplements containing vitamin D are available on prescription or for sale without a prescription from pharmacies, shops and online in many countries. However, there is wide variation in the content and price, and some supplements may not be suitable for at-risk groups.

Table 3.71

Main resource requirements for vitamin D supplementation of breastfed, term infants.

Additional considerations

In the USA, daily vitamin D supplementation has been recommended for breastfed infants since 2008 (219). In an examination of trends in meeting vitamin D intake among infants in the USA since 2009 (220), only 20.5% of breastfed infants were found to meet the intake requirements of 400 IU/day of vitamin D. Breastfed infants in families with a total income ³ 400% of the federal poverty level, with a head of household being a college graduate, and with private health insurance, were more likely to meet the intake guidelines. The authors suggested that renewed considerations are needed for how best to meet recommended vitamin D intake for infants.

Additional considerations

A survey of breastfeeding mothers showed just over half supplemented their young infants with vitamin D in the preceding week, with 42% receiving the recommended dose of 400 IU (221). Most found administering vitamin D supplements easy, but 6% found it burdensome. The great majority (88%) of mothers preferred to supplement themselves rather than their infants. Reasons for not supplementing infants with vitamin D included lack of knowledge about supplementation, belief that breastmilk provided infants with adequate vitamin D, inconvenience, or their infant’s apparent dislike of the supplement (221).

An observational study of a primary care practice in the USA showed just over 36% of paediatricians recommended vitamin D supplementation for breastfed newborns (222). Those who did not recommend supplementation were more likely to believe that the guidance to supplement was not evidence-based. Only 44.6% of parents of infants whose paediatrician recommended supplements actually provided them. About two thirds of parents of infants predominantly breastfed for at least six months believed breastmilk contained adequate amounts of nutrients for infants, and only 3% of their infants received vitamin D supplementation (222).

There is some concern among health workers and breastfeeding advocates that recommendations to supplement breastmilk with vitamin D will imply to women that formula is superior to breastmilk (223, 224). This implication may result in fewer women choosing to breastfeed and/or more women reducing or discontinuing breastfeeding.

Additional considerations

Surveys conducted in Canada (225, 226) and Ireland (227), where there are national recommendations for vitamin D supplementation of young infants, report variable implementation, from about half to 92%. Women from British Columbia, Canada, who provided vitamin D supplementation to their breastfed infants recalled hearing the recommendations at least once from a public health nurse or physician, understood breastmilk had inadequate amounts of vitamin D, and believed supplementation provided health benefits to the infant (225).

Poor adherence with long-term micronutrient supplementation regimens and costs to consumers have been cited as practical limitations for LMICs (218). Adherence is often influenced by individual, social and environmental factors, including personal beliefs, the motivation of the mother or caregiver, social networks, health workers, others involved in the delivery of programmes and the local health system structure.

Vitamin D3 supplements (cholecalciferol) are listed in the WHO Model List of Essential Medicines for Children (oral liquid: 400 IU/ml; solid oral dosage form: 400 IU; 1000 IU) (181). Vitamin D2 (ergocalciferol) is listed as a suitable alternative. Some vitamin D supplements need to be stored in cool conditions (e.g. below 25 °C) and some require refrigeration once opened.

Table 3.72

Summary of judgements: Vitamin D supplementation compared with placebo or no supplementation.

Comparison: Whole-body massage compared with no massage

Newborn/infant outcomes

Growth: It is uncertain whether newborn whole-body massage has any effect on newborn weight at the end of the intervention period, or weight at follow-up at 8–12 months, when compared with no massage (very low-certainty evidence). Low-certainty evidence suggests newborn whole-body massage may increase infant length at the end of intervention period when compared with no massage (8 trials, 1260 newborns; MD 1.53 cm longer, 1.37 cm to 1.70 cm longer). It is uncertain whether newborn whole-body massage has any effect on infant length at 12 months follow-up when compared with no massage (very low-certainty evidence). It is uncertain whether newborn whole-body massage has any effect on infant head circumference at the end of intervention period or head circumference at six months follow-up when compared with no massage (very low-certainty evidence).

Severe neonatal/infant morbidity: It is uncertain whether newborn whole-body massage has any effect on newborn bilirubin levels at four days after birth when compared with no massage (very low-certainty evidence).

Sleep characteristics: It is uncertain whether newborn massage has any effect on newborn sleep duration at the end of intervention period or at 24 months follow-up when compared with no intervention (very low-certainty evidence).

Neurodevelopment: It is uncertain whether newborn whole-body massage has any effect on infant Psychomotor Development Index scores at the end of intervention period or at 24 months follow-up when compared with no massage (very low-certainty evidence). It is uncertain whether newborn whole-body massage has any effect on infant Mental Development Index scores at the end of intervention or at 24 months follow-up when compared with no massage (very low-certainty evidence). It is uncertain whether newborn whole-body massage has any effect on infant development (gross motor, fine motor, language, personal social behaviour) at the end of the intervention period (measured using the Gesell development quotient or Capital Institute mental checklist), or at 12 months follow-up (measured using the Gesell development quotient), when compared with no massage (very low-certainty evidence).

Adverse effects were not reported in the included studies.

Maternal outcomes

Maternal functioning/well-being: It is uncertain whether newborn whole-body massage has any effect on the Maternal Attachment Inventory score when compared with routine care (very low-certainty evidence). It is uncertain whether newborn massage has any effect on crying or fussing time at the end of the intervention period, and at six months follow-up when compared with no intervention (very low-certainty evidence).

Additional considerations

A 2013 Cochrane Review, which included 34 RCTs, assessed the effect of massage on infants under 6 months of age (234). The meta-analysis favoured the intervention in terms of better weight, length and head circumference growth as well as developmental outcomes. However, the quality of evidence was rated very low for most outcomes. Twenty-four trials from the Cochrane systematic review overlap with the current review, while four new trials were conducted after the publication of this review in 2013.

Another systematic review and meta-analysis published in 2019 (235) evaluated the influence of massage on hyperbilirubinaemia. The review included six RCTs involving 357 full-term neonates and found significantly lower transcutaneous bilirubin after four days of massage therapy. Two trials from the current systematic review overlap with this review, while other trials from the 2019 review did not qualify for the present review as the population was jaundiced so not healthy newborns.

Resources

No economic evaluations of whole-body massage with/without oil in term newborns were identified.

Table 3.73

Main resource requirements for whole-body massage.

Additional considerations

Infant massage is a therapy that may be performed by parents and other caregivers. Findings from an American study in which fathers were encouraged to massage their infants for 15 minutes each evening over a three-week period highlight several benefits including, relieving infant stress (soothing), relieving maternal stress (caregiving), increased confidence, and increased contribution. In addition, fathers expressed a desire for further access and opportunities for interaction with their infants (237).

Feasibility

A qualitative evidence synthesis of women’s experiences of postnatal care found no direct evidence relating to women’s views on the feasibility of using massage on term newborns (28). Indirect evidence suggests women are likely to appreciate the practical, low-cost nature of this therapy (moderate confidence in the evidence) and the basic principles of massage are likely to be understood across a broad range of settings and contexts (moderate confidence in the evidence). A qualitative evidence synthesis of health workers’ experiences of postnatal care found no direct evidence relating to views on the feasibility of using massage on term newborns (29). However, indirect evidence suggests that lack of personnel, resources and training may limit provision of information and counselling on newborn massage in the postnatal period (moderate confidence in the evidence).

Table 3.74

Summary of judgements: Whole-body massage compared with no massage.

Values

See Box 3.14 in section 3.C: Health systems and health promotion interventions.

In addition, evidence from a qualitative evidence synthesis exploring what women want from postnatal care (21) indicates that women may experience periods of low mood, loneliness, anxiety and fatigue during the postnatal period (moderate confidence in the evidence) and appreciate the advice, reassurance and support (practical and emotional) they receive from health workers and family members during this time (high confidence in the evidence). Some women may struggle with labour- and birth-induced trauma (physical and psychological) (high confidence in the evidence) and/or experience difficulties with breastfeeding or find it difficult to embrace their maternal identity (moderate confidence in the evidence), so are likely to value regular engagement with health workers to resolve these concerns. Further, women tend to prioritize the needs of their baby during the postnatal period (moderate confidence in the evidence), so are likely to value clinical and developmental outcomes associated with their infant.

Resources

No economic evaluations of more frequent compared with less frequent postnatal care contacts were identified.

Equity

No direct evidence was identified on the impact on health equity of more frequent compared with less frequent postnatal care contacts.

Schedules of postnatal care involving more contacts may increase equity, particularly if they ensure coverage among woman–infant dyads from low socioeconomic groups or in rural areas, who are less likely to receive postnatal care and have higher rates of preventable maternal, perinatal and neonatal mortality. However, these schedules may decrease equity if coverage is lower in low socioeconomic groups, in rural areas, or if women and families are expected to cover the cost of more frequent postnatal care contacts.

Acceptability

Evidence from a qualitative evidence synthesis exploring women’s experiences of postnatal care (28) indicates that women appreciate and value the practical, psychosocial and emotional support they receive from health workers during the postnatal period (high confidence in the evidence). Some women, particularly in HICs, feel that they want more support from health workers during the postnatal period as well as flexible contact opportunities, including regular home visits, drop-in clinics, out-of-hours services and telephone availability (moderate confidence in the evidence). Where regular postnatal contact services are already in place, women appreciate being seen by the same care provider to establish trust and familiarity with personal circumstances (moderate confidence in the evidence).

In some LMIC settings, women only engage with postnatal services when they feel there is something wrong with themselves or their babies (moderate confidence in the evidence). Evidence also indicates that some women, particularly in LMICs, are unlikely to welcome additional engagement with postnatal providers in circumstances where the additional costs outweigh the perceived benefits, where there is a lack of trust in formal health systems, where women perceive there to be a culture of mistreatment or where adherence to traditional postnatal practices may be disrupted (moderate confidence in the evidence).

Feasibility

A qualitative evidence synthesis exploring women’s experiences of postnatal care (28) found no direct evidence relating to the feasibility of increasing the number of postnatal contacts. Indirect evidence indicates that the proximity of the health facility may encourage additional engagement with postnatal services, particularly in LMICs; that is, geographical closeness facilitates access for women and community engagement by health workers (low confidence in the evidence). Evidence also suggests the costs associated with extra visits to the health facility may limit access for some women, while the health system resources required (additional staff, travelling costs) to provide home visits may be prohibitive in some LMIC settings (low confidence in the evidence).

A qualitative evidence synthesis of health workers’ experiences of postnatal care found no direct evidence relating to views on the feasibility of increasing the number of postnatal contacts (29). However, indirect evidence suggest that lack of personnel, resources and training may limit the availability and quality of postnatal care services (moderate confidence in the evidence). Sometimes, health workers had to prioritize some services or care over others (low confidence in the evidence). Providers appreciated continuity of care to be able to establish trusting relationships, assess women’s emotional well-being and improve their experience of care (moderate confidence in the evidence). By contrast, lack of continuity of care or common policies or guidelines across different cadres and levels of maternal health services may limit the offer of consistent information and counselling (moderate confidence in the evidence). Providers believed postnatal/parental education was sometimes superficial and provided too late (low confidence in the evidence).

Table 3.76

Summary of judgements: More frequent compared with less frequent postnatal care contacts.

Values

See Box 3.14 in section 3.C: Health systems and health promotion interventions.

In addition, findings from a qualitative evidence synthesis exploring what women want from postnatal care (21) indicate that women want to form an immediate relationship with their baby (moderate confidence in the evidence) and value the practical and emotional support offered by health workers to enable mother–baby bonding (high confidence in the evidence). Women appreciate tailored care and support during the immediate postnatal period, including an understanding that informational needs, as well as individual capacity to assimilate information, may vary from woman to woman (moderate confidence in the evidence). In some settings, perceived staff shortages and/or the disruptive nature of postnatal wards (lack of privacy, hospital visits, ward rounds) may lead to inadequate care and a perception among some women that they are discharged too early from a health facility feeling ill-prepared and lacking in confidence about their ability to cope at home (moderate confidence in the evidence).

Findings from a qualitative evidence synthesis on the perspectives of women, men and health workers related to postnatal hospital discharge (91) indicate that women value postnatal education for themselves and their partners and families to ensure parental confidence, and the opportunity to practice care with the support of a midwife (moderate confidence in the evidence). Both women and men value their autonomy in relation to the discharge process (moderate confidence in the evidence), including decisions regarding the timing of the discharge, adequate recognition by staff at the hospital, and availability of care without direct interference and intrusiveness.

Resources

No economic evaluations of policies of early discharge from health facilities after term, uncomplicated vaginal birth were identified. One trial (259) reported costs of hospital care between the period immediately following vaginal birth up to the time of discharge as US$ 382.22 (213 women) in the early discharge group (24 hours or less with one home visit) and US$ 647.67 (217 women) in the late discharge group (at least 48 hours). The same trial reported a reduced combined cost of community care and maternal and neonatal readmissions for the early discharge group, where costs were US$ 28.66 less.

Equity

No direct evidence was identified on the impact on health equity of a policy of early discharge from health facilities after uncomplicated, term vaginal birth.

An analysis of factors associated with length of stay after childbirth using data from Demographic and Health Surveys (DHS) in 30 countries suggests women of older age and those attended by doctors had longer length of stays. Women attended by non-skilled staff consistently had shorter lengths of stay than those attended by nurse-midwives, as well as wealthier women, or those who delivered by caesarean birth in the private sector (11).

A policy of early discharge from a health facility after uncomplicated, term vaginal birth may decrease equity if coverage of postnatal care before and after discharge for woman–infant dyads is lower in low socioeconomic groups or in rural areas, or if women and families are expected to cover the cost of postnatal care visits after discharge or other costs (e.g. transport to outpatient care, child care support of siblings, loss of income if a partner/family member required time off work). However, early discharge policies may increase equity if accompanied by strategies (e.g. home visits) to ensure follow-up after discharge for all woman–infant dyads.

Acceptability

Evidence from a qualitative evidence synthesis exploring the perspectives of women, men and health workers on discharge (22) indicates that care for women is often seen to be overlooked during the postnatal care period, with predominant emphasis put on the care of the baby (moderate confidence in the evidence) and assumptions that women receive the information they need during antenatal care (low confidence in the evidence). The discharge process is often viewed as rushed by both women and health workers, with too much information, and many time limitations and health workforce shortages (low confidence in the evidence). Women and parents would appreciate more knowledge and practical skills related to taking care of themselves and their newborns, and mitigating postpartum depression (moderate confidence in the evidence). Women and partners, as well as health workers, appreciate the engagement and preparation of parents and families in relation to postnatal care (moderate confidence in the evidence). Health workers indicated that they would appreciate more tailored guidelines and training for providing postnatal education to women and families (moderate confidence in the evidence).

Evidence from a qualitative evidence synthesis exploring women’s experiences of postnatal care (28) indicates that women need help with infant feeding, bathing and changing, as well as opportunities for recuperation and rest (high confidence in the evidence). Women, especially first-time mothers, may require time to assimilate pre-discharge information to feel confident in their ability to cope at home (high confidence in the evidence). This includes specific information about infant behaviours (feeding, sleeping and crying cues) and infant safety, development and well-being. Some women look to health workers for information to meet personal needs relating to perineal trauma, pain, wound care and emotional well-being (high confidence in the evidence). The same review also highlights the importance of the postnatal environment and suggests that, for some women, their inability to control the often noisy and disruptive atmosphere on postnatal wards can generate feelings of frustration and despair, prompting some to leave earlier than planned (moderate confidence in the evidence).

Feasibility

The qualitative evidence synthesis on the perspectives of women, men and health workers (91) suggests that the lack of time due to staff shortages (low confidence in the evidence), lack of staff training (moderate confidence in the evidence), unavailability of information in different languages, financial/insurance constraints affecting the length of stay, and societal norms affecting how postnatal care education is received (moderate confidence in the evidence) may limit the delivery of discharge preparation approaches.

A qualitative evidence synthesis of health workers’ views and experiences of postnatal care found no direct evidence relating to views on timing of discharge after birth (29). However, indirect evidence suggest that lack of personnel and heavy workload constrained the availability and quality of services, including care around the time of discharge after childbirth. Administrative duties related to discharge and paperwork added to health workers’ workload and made some midwives feel that their ability to provide quality, woman-centred care was compromised as they were not able to spend enough time with each woman and to assess their needs; problems for the mother or her baby were therefore not always fully addressed. Providers perceived the need to build trustful, sensitive relationships with women, and to provide them with sufficient and timely information (low confidence in the evidence).

Table 3.78

Summary of judgements: Early discharge following vaginal birth compared with usual discharge.

Values

Evidence around the values of women is the same as for the previous comparison.

Resources

No economic evaluations of policies of early discharge from health facilities after caesarean birth were identified.

One trial (265) reported on the costs of hospital care for the period immediately following an unplanned caesarean birth up to the time of discharge. These costs were US$ 7648 (71 women) in the group with early discharge, home visits and phone-based follow-up (mean stay of 3.6 days) and US$ 10 971 (71 women) in the late discharge group (mean stay of 4.8 days) (cost difference between groups of US$ 3323). The same trial reported combined costs of community care (mean cost of nurse-specialist visits [in hospital and at home], home caregiver charges, acute care visits [following discharge] and rehospitalization charges), from US$ 516 (61 women) for those in the early discharge group (24 hours or less after caesarean birth) to US$ 519 (61 women) for those in the late discharge group (at least 48 hours after caesarean birth) (cost difference between groups of US$ 3).

Table 3.79

Main resource requirements for early discharge following caesarean birth.

Equity

No direct evidence was identified on the impact on health equity of a policy of early discharge from health facilities after caesarean birth. Other evidence is the same as for the previous comparison.

Acceptability

Evidence around acceptability is the same as for the previous comparison.

Feasibility

Evidence around feasibility is the same as for the previous comparison.

Table 3.80

Summary of judgements: Early discharge following caesarean birth compared with usual discharge.

Values

See Box 3.14 in section 3.C: Health systems and health promotion interventions.

In addition, a qualitative evidence synthesis on the perspectives of women, men and health workers related to postnatal hospital discharge (22) suggests that women value postnatal education for themselves and their partners and families to ensure parental confidence, and the opportunity to practice care with the support of a midwife (moderate confidence in the evidence). Both women and men value their autonomy in relation to the discharge process (moderate confidence in the evidence), including decisions regarding the timing of the discharge, adequate recognition by staff at the hospital, and availability of care without direct interference and intrusiveness.

A qualitative evidence synthesis exploring what women want from postnatal care (21) indicates that women value a variety of information and sources of support to help them cope with the transition to motherhood (high confidence in the evidence). To assist with this transition, women describe a range of health worker characteristics including the ability to offer safe, kind, respectful care and the sensitivity to acknowledge individual needs and cultural preferences (moderate to high confidence in the evidence).

Resources

The scoping review on discharge preparation and readiness in facilities prior to discharge after birth included any type of document describing discharge after birth, including published research of economic evaluations. No economic studies were identified.

Table 3.81

Main resource requirements for assessing discharge readiness prior to discharge from the health facility after birth.

Equity

No direct evidence was identified from the scoping review on the impact on health equity of assessing discharge readiness prior to discharge from the health facility after birth. Use of the criteria as part of discharge assessment may increase equity, as it may identify women, newborns and families most in need of further care and support, thereby identifying targeted interventions that lead to efficient management and use of health-care resources.

Acceptability

The qualitative evidence synthesis on the perspectives of women, men, and health workers from the scoping review found that parents would appreciate procedures during postnatal hospital discharge that would enhance their knowledge and practical skills related to taking care of themselves and their newborns and mitigate postpartum depression (moderate confidence in the evidence) (22).

The findings also indicate that care for women is often seen to be overlooked during the postnatal period, with predominant emphasis put on the care of the baby (moderate confidence in the evidence) and assumptions that women receive the information they need during antenatal care (low confidence in the evidence). The discharge process is often viewed as rushed by both women and health workers, with too much information, and many time limitations and health workforce shortages (low confidence in the evidence). In some instances, women may prefer to get home quickly (low confidence in the evidence). Health workers indicated they would appreciate more tailored guidelines and training for providing postnatal education to women and families (moderate confidence in the evidence), and women and men, as well as health workers, appreciate the engagement and preparation of both parents and families in postnatal care (moderate confidence in the evidence).

Indirect evidence from a qualitative synthesis of women’s experiences of postnatal care (28) indicates that women welcome clear and consistent discharge information, particularly if it is tailored to suit their individual needs (high confidence in the evidence). Evidence from the same review also indicates that, while women recognize the clinical priority of monitoring infant or neonatal outcomes, they also feel that postnatal assessments should incorporate maternal psychological and emotional well-being (high confidence in the evidence). Women are therefore less likely to appreciate criteria for discharge readiness that focus solely on infant-related clinical and developmental outcomes and/or clinical or physiological maternal outcomes (high confidence in the evidence).

Feasibility

The qualitative evidence synthesis on the perspectives of women, men and health workers on discharge suggests that the lack of time due to staff shortages (low confidence in the evidence), lack of staff training (moderate confidence in the evidence), unavailability of information in different languages, financial/insurance constraints affecting the length of stay, and societal norms affecting how postnatal care education is received (moderate confidence in the evidence) may limit the use of criteria for discharge assessment (22).

Indirect evidence from a qualitative synthesis of women’s experiences of postnatal care (28) suggests that in some contexts there are staff shortages, a lack of basic resources and a lack of privacy in postnatal settings, all of which may impact on providers’ capacity to complete a more comprehensive discharge assessment of women in their care (low to moderate confidence in the evidence).

Indirect evidence from a qualitative evidence synthesis of health workers’ views and experiences of postnatal care (29) suggests that a lack of personnel and heavy workload constrained the availability and quality of services, including care around the time of discharge after childbirth. Administrative duties related to discharge and paperwork added to health workers’ workload and made some midwives feel that their ability to provide quality, woman-centred care was compromised as they were not able to spend enough time with each woman and to assess their needs; thus problems for the mother or her baby were not always fully addressed. Indirect evidence also suggests that postnatal care providers felt they lack sufficient training on newborn examinations (moderate confidence in the evidence). Providers perceived the need to build trustful, sensitive relationships with women, and to provide them with sufficient and timely information (low confidence in the evidence). The lack of continuity of care and common policies or guidelines across different cadres and levels of maternal health services may limit the offer of consistent information and breastfeeding counselling (moderate confidence in the evidence).

Table 3.82

Summary of judgements: Use of criteria for discharge assessment compared with no criteria or other criteria.

Values

See Box 3.14 in section 3.C: Health systems and health promotion interventions.

In addition, a qualitative evidence synthesis on the perspectives of women, men and health workers related to postnatal hospital discharge (22) suggests that women value postnatal education for themselves and their partners and families to ensure parental confidence, and the opportunity to practice care with the support of a midwife (moderate confidence in the evidence). Both women and men value their autonomy in relation to the discharge process (moderate confidence in the evidence), including decisions regarding the timing of the discharge, adequate recognition by staff at the hospital, and availability of care without direct interference and intrusiveness.

In addition, a qualitative evidence synthesis exploring what women want from postnatal care (21) indicates that women value a variety of information and sources of support to help them cope with the transition to motherhood (high confidence in the evidence). To assist with this transition, women describe a range of health worker characteristics including the ability to offer safe, kind, respectful care, and the sensitivity to acknowledge individual needs and cultural preferences (moderate to high confidence in the evidence).

Resources

The scoping review on discharge preparation and readiness in facilities prior to discharge after birth included any type of document describing discharge after birth, including published research of economic evaluations. No economic studies were identified.

Table 3.83

Main resource requirements for strengthening preparation for discharge from the health facility to home after birth.

Equity

No direct evidence was identified from the scoping review on the impact on health equity of approaches for delivering discharge preparation. Approaches to deliver discharge preparation may increase equity, as these may facilitate delivery of targeted care to women, newborns and families in accordance with their needs and contexts. However, delivery of such interventions may require health-care infrastructure and trained health workers, which are limited in many low-income countries. Discharge preparedness interventions that use written materials could impact equity if efforts are not employed to address the needs of populations who do not read, or if different language needs are not considered.

Acceptability

The qualitative evidence synthesis on the perspectives of women, men, and health workers on discharge (22) found that mothers and fathers would appreciate procedures during postnatal hospital discharge that would enhance their knowledge and practical skills related to taking care of themselves and their newborns, and how to mitigate postpartum depression (moderate confidence in the evidence). Care for women is often overlooked during the postnatal period, with predominant emphasis on the care of the baby (moderate confidence in the evidence), and an assumption that women receive the information they need during antenatal care (low confidence in the evidence). The discharge process is often viewed as rushed by both women and health workers, with too much information and many time limitations and health workforce shortages (low confidence in the evidence). In some instances, women may prefer to get home quickly (low confidence in the evidence). Health workers indicated they would appreciate more tailored guidelines and training for providing postnatal education to women and families (moderate confidence in the evidence), and both women and men, as well as health workers, appreciate the engagement and preparation of parents and families in postnatal care (moderate confidence in the evidence).

Indirect evidence from a qualitative synthesis of women’s experiences of postnatal care (28) indicates that women welcome clear and consistent discharge information, particularly if it is tailored to suit their individual needs (high confidence in the evidence). Evidence from the same review also indicates that women may be coming to terms with a wide variety of challenging emotions during the early postnatal period (including joy, fatigue, depression, exhaustion and trauma) so may not be receptive to large amounts of information relating to discharge practices (moderate to high confidence in the evidence). Women are therefore likely to appreciate flexible approaches to discharge preparation, incorporating multiple contacts with health workers, opportunities to discuss issues and concerns with relevant staff, and information on how to access services and staff post-discharge (moderate to high confidence in the evidence).

Feasibility

The qualitative evidence synthesis on the perspectives of women, men, and health workers (22) suggests that the lack of time due to staff shortages (low confidence in the evidence), lack of staff training (moderate confidence in the evidence), unavailability of information in different languages, financial/insurance constraints affecting the length of stay and societal norms affecting how postnatal care education is received (moderate confidence in the evidence) may limit the delivery of discharge preparation approaches.

Indirect evidence from a qualitative synthesis of women’s experiences of postnatal care (28) suggests that in some contexts there are staff shortages, a lack of basic resources and a lack of privacy in postnatal settings, all of which may impact on the capacity to provide adequate discharge preparation for women (low to moderate confidence in the evidence).

Indirect evidence from a qualitative evidence synthesis of health workers’ views and experiences of postnatal care (29) suggest that lack of personnel and heavy workload constrained the availability and quality of services, including care around the time of discharge after childbirth. The lack of continuity of care and common policies or guidelines across different cadres and levels of the maternal health services may also limit the offer of consistent information and breastfeeding counselling (moderate confidence in the evidence).

Table 3.84

Summary of judgements: Approaches for strengthening discharge preparation compared with usual care.

Values

See Box 3.14 in section 3.C: Health systems and health promotion interventions.

In addition, evidence from a qualitative evidence synthesis exploring what women want from postnatal care (21) indicates that women may experience periods of low mood, loneliness, anxiety and fatigue during the postnatal period (moderate confidence in the evidence) and appreciate the advice, reassurance and support (practical and emotional) they receive from health workers and family members during this time (high confidence in the evidence). Some women may struggle with labour and birth-induced trauma (physical and psychological) (high confidence in the evidence) and/or experience difficulties with breastfeeding or find it difficult to embrace their maternal identity (moderate confidence in the evidence) so are likely to value home visits by health workers to resolve these concerns. In addition, women tend to prioritize the needs of their baby during the postnatal period (moderate confidence in the evidence) so are likely to value clinical and developmental outcomes associated with their infant.

Resources

A systematic review (244) assessing the effectiveness and cost-effectiveness of home visits during the early postnatal period compared with no home visits identified two economic evaluations (269, 270) (high quality), conducted alongside clinical trials in Ghana and Bangladesh, reporting on the incremental cost for neonatal mortality outcomes. Home-based neonatal care strategies were found to be cost-effective as reported in terms of cost per neonatal death averted, newborn life-year saved or DALY averted, after costs were inflated to 2016 prices and using the GDP per capita as a benchmark.

Equity

No direct evidence was identified on the impact on health equity of postnatal home visits compared with usual care. Postnatal home visits may increase equity if coverage is achieved among woman–infant dyads from low socioeconomic groups and rural areas who are less likely to receive postnatal care, or after home births. Postnatal home visits may further increase equity if they reduce costs for women and families, including cost of transport and childcare of siblings, thus supporting and enabling attendance at outpatient postnatal care. However, it may decrease equity if coverage of home visits is lower in low socioeconomic groups or rural areas, or if women and families are expected to cover the cost of postnatal care visits.

Acceptability

Evidence from a qualitative evidence synthesis exploring women’s experiences of postnatal care (28) indicates that women appreciate and value the practical, psychosocial and emotional support they receive from health workers during the postnatal period (high confidence in the evidence). Evidence also suggests that, once women are at home, they appreciate a variety of contact opportunities with postnatal services to smooth their transition into motherhood (moderate confidence in the evidence). The provision of home visits is highlighted by women in a number of different contexts as being of particular benefit since they are convenient and more relaxing for women and may give health workers important insights into the family’s domestic circumstances (moderate confidence in the evidence). The availability of drop-in clinics, outof-hours services, and telephone or online services is also appreciated by women (and families) who require ongoing reassurance and support from health workers at home (moderate confidence in the evidence). In situations where home visits are already in place, women appreciate being seen by the same health professional to establish trust and familiarity with personal circumstances (moderate confidence in the evidence).

Feasibility

A qualitative evidence synthesis exploring women’s experiences of postnatal care (28) found no direct evidence relating to the feasibility of postnatal home visits. Indirect evidence suggests the resources required (additional staff, travelling costs) to provide home visits to the community may be prohibitive in some LMIC settings, particularly in rural areas (low confidence in the evidence).

A qualitative evidence synthesis of health workers’ views and experiences of postnatal care (29) suggests conducting home visits may sometimes be challenging for health workers, given cultural norms, difficulties accessing the homes (poor road conditions, long distances, inconvenient means of transport). Lack of personnel and a heavy workload constrained their availability to conduct postnatal care visits (low confidence in the evidence). Health workers would sometimes prioritize some services over home visits. Public health nurses perceived home visits to be less valuable and not properly understood by their professional colleagues and managers, and expressed concern that if such programmes were eliminated some women might not have access to alternative postnatal care (low confidence in the evidence). Health workers suggested reasons women may not attend clinics include lack of transport, lack of money, misconceptions that health workers are hoarding supplies and making unwarranted financial gains, cultural beliefs and practices, lack of knowledge of the importance of some services and language barriers (moderate confidence in the evidence).

Values

See Box 3.14 in section 3.C: Health systems and health promotion interventions.

In addition, evidence from a qualitative evidence synthesis exploring what women want from postnatal care (21) indicates that women may experience periods of low mood, loneliness, anxiety and fatigue during the postnatal period (moderate confidence in the evidence) and appreciate the advice, reassurance and support (practical and emotional) they receive from health workers and family members during this time (high confidence in the evidence). Some women may struggle with labour and birth-induced trauma (physical and psychological) (high confidence in the evidence) and/or experience difficulties with breastfeeding or find it difficult to embrace their maternal identity (moderate confidence in the evidence) so are likely to value home visits by health workers to resolve these concerns. In addition, women tend to prioritize the needs of their baby during the postnatal period (moderate confidence in the evidence) so are likely to value clinical and developmental outcomes associated with their infant.

Resources

No economic evaluations of postnatal home visits compared with routine outpatient postnatal care were identified.

Equity

No direct evidence was identified on the impact on health equity of postnatal home visits compared with routine outpatient care. Postnatal home visits may increase equity if coverage is achieved among women from low socioeconomic groups and rural areas, who are less likely to receive postnatal care in health facilities. Postnatal home visits may further increase equity if they reduce costs for women and family, including cost of transport and childcare of siblings, thus supporting and enabling attendance at outpatient postnatal care. However, it may decrease equity if coverage of home visits is lower in low socioeconomic groups or rural areas, or if women and families are expected to cover the cost of postnatal care visits.

Acceptability

Evidence from a qualitative evidence synthesis exploring women’s experiences of postnatal care (28) indicates that women appreciate and value the practical, psychosocial and emotional support they receive from health workers during the postnatal period (high confidence in the evidence). Evidence also suggests that, once women are at home, they appreciate a variety of contact opportunities with postnatal services to smooth their transition into motherhood (moderate confidence in the evidence). The provision of home visits is highlighted by women in a number of different contexts as being of particular benefit since they are convenient and more relaxing for women and may give health workers important insights into the family’s domestic circumstances (moderate confidence in the evidence). The availability of drop-in clinics, outof-hours services, and telephone or online services is also appreciated by women (and families) who require ongoing reassurance and support from health workers at home (moderate confidence in the evidence). In situations where home visits are already in place, women appreciate being seen by the same care provider to establish trust and familiarity with personal circumstances (moderate confidence in the evidence).

Feasibility

A qualitative evidence synthesis exploring women’s experiences of postnatal care (28) found no direct evidence relating to the feasibility of postnatal home visits. Indirect evidence suggests the resources required (additional staff, travelling costs) to provide home visits to the community may be prohibitive in some LMIC settings, particularly in rural areas (low confidence in the evidence).

A qualitative evidence synthesis of health workers’ views and experiences of postnatal care (29) suggests conducting home visits may sometimes be challenging for health workers, given cultural norms, difficulties accessing the homes (poor road conditions, long distances, inconvenient means of transport). Lack of personnel and heavy workload constrained their availability to conduct postnatal care visits (low confidence in the evidence). Health workers would sometimes prioritize some services over home visits. Public health nurses perceived home visitation to be less valued and not properly understood by their professional colleagues and managers, and expressed concern that if such programmes were eliminated some women might not have access to alternative postnatal care (low confidence in the evidence). Health workers suggested the reasons women may not attend clinics include lack of transport, lack of money, misconceptions that health workers are hoarding supplies and making unwarranted financial gains, cultural beliefs and practices, lack of knowledge of the importance of some services, and language barriers (moderate confidence in the evidence).

Values

See Box 3.14 in section 3.C: Health systems and health promotion interventions.

In addition, a qualitative evidence synthesis explored women, men, and health workers’ perceptions of interventions to influence men’s involvement in maternal and newborn health (30). The findings indicated that men, women and health workers value access to maternal and newborn health services and quality maternal and newborn health care (high confidence in the evidence). Women, men and health workers also value the practical and emotional support provided by men to women and newborns (high confidence in the evidence). Men in particular value opportunities for enhanced father-newborn bonding (high confidence in the evidence). It is therefore highly likely that increased access to, and use of, maternal and newborn health services, as well as improved care of women and newborns in the home associated with improved men’s engagement, will be valued by women and men as well as health workers. Good maternal and newborn health is important to most men (high confidence in the evidence), and if men believe that participating in the intervention and adopting behaviours recommended by the intervention will improve maternal and newborn health, then many men are happy to participate in interventions and adhere to intervention messages.

Resources

No economic evaluations of interventions to promote men’s involvement in maternal and newborn health were identified.

Equity

The qualitative evidence synthesis exploring women’s, men’s, and health workers’ perceptions of interventions to influence men’s involvement in maternal and newborn health (30) found evidence that interventions can support improved gender equity between women and men in couple or co-parent relationships. Interventions can help men and women to share the care of newborns more equally, by empowering men as confident caregivers, and supporting them to feel that their involvement in their child’s care can be equal to that of the child’s mother (moderate confidence in the evidence). Interventions can also foster mutual understanding and support, and facilitate communication and shared decision-making about maternal and newborn health (high confidence in the evidence). There is some evidence that increased mutual understanding and shared decision-making may contribute to more equitable couple or co-parent relationships.

The qualitative review also found evidence that risks of harm associated with poorly designed, targeted or implemented interventions are distributed inequitably, with these risks more likely to affect single women, women from low-income families, and women in settings and/or relationships characterized by gender power imbalances (moderate confidence in the evidence).

Women, men and families from poorer households are less able to access the reported benefits of facility-based interventions to involve men, including benefits relating to men’s presence as labour companions, as these men are often in insecure paid work, under economic pressure to travel or migrate for work, or lack access to parental or carer’s leave (low confidence in the evidence).

Interventions that seek to encourage partner attendance at antenatal appointments can stigmatize, and reduce the quality of services provided to, women who are not accompanied by a man (moderate confidence in the evidence).

Women in settings with highly gender-unequal social norms, and/or women in relationships likely to be characterized by a substantial gender power imbalance (including girls aged less than 18 years, girls and women in relationships with much older men, girls and women in polygamous relationships, and girls and women in violent or controlling relationships), are more likely to be negatively impacted by poorly designed interventions that perpetuate and/or extend the impact of existing unequal gender norms (moderate confidence in the evidence).

Acceptability

The qualitative evidence synthesis exploring women’s, men’s, and health workers’ perceptions of interventions to influence men’s involvement in maternal and newborn health (30) found that men and women may find interventions to influence men’s engagement in maternal and newborn health acceptable because they believe that these interventions will contribute to good maternal and newborn health (high confidence in the evidence) and/or happy, mutually supportive couple relationships (low confidence in the evidence). Conversely, where women or men believe these interventions will increase conflict in their couple relationships, then they find the interventions less acceptable/unacceptable (low confidence in the evidence).

Some women, men and health workers may not want men to engage differently, because of beliefs that women have a greater capacity compared with men to provide care, particularly for newborns. Women may also be concerned about losing decision-making autonomy in the domain of maternal and newborn health and/or losing access to women-only spaces relating to maternal and newborn health that can provide a valued social space for women to connect with and support each other (low confidence in the evidence).

Established gender norms can make intervention messages about men being competent caregivers, sharing responsibility for maternal and newborn health, and providing support to women and care for newborns, unacceptable to some men, women and health workers (low confidence in the evidence).

Feasibility

The findings from the qualitative synthesis (30) indicate that interventions that promote men’s participation in facility-based maternal and newborn health services are more feasible to implement where there is an enabling health system environment (high confidence in the evidence). In LMIC settings, there may be limited health system capacity to make maternal and newborn health services more men-friendly by investing in health worker training, changing service delivery, changing physical spaces, or offering new services. This may make men feel unwelcome and discouraged from participating.

Established gender norms that are supportive of women, and not men, being responsible for maternal and newborn health discourage some women and men from participating in interventions – either due to their own internalized norms, health workers’ norms and attitudes, or pressure from peers, family and community members. This forms a demand-side barrier to men’s and women’s uptake of and adherence to interventions (low confidence in the evidence).

Some men are not available to participate in interventions due to insecure paid work, economic pressure to travel or migrate for paid work, or lack of access to parental leave. Tailoring interventions by location and time so that men are available may enable higher participation (low confidence in the evidence).

Table 3.90

Summary of judgements: Interventions to promote men’s involvement in maternal and newborn health compared with no intervention, usual care or other intervention.