• On admission in labour
• During established labour

PROTOCOL AS USED IN CG190 (2014) – 2016 EVIDENCE REVIEW TO BE PERFORMED IN ACCORDANCE WITH CG190 METHODS SECTION (1.10.2 AND 1.10.3)

THESE QUESTIONS WERE PRIORITISED FOR HEALTH ECONOMIC ANALYSIS IN CG190

One search - weed into 2 reviews

• Randomised controlled trials (RCTs)
• Comparative observational studies (if no RCT data)

• cardiotocograph (CTG)
• admission CTG

• Doppler fetal monitors (“Sonicaid”)
• hand-held ultrasound devices
• Pinard stethoscope
• fetal stethoscope
• listening in
• non-stress test (NST)

• Mode of birth
• Women’s satisfaction/experience of labour and birth including mobility

• Mortality
• Major neonatal morbidity (any - see opposite for GDG decision)
• Admission to NICU
• Cord blood gas values at birth

• hypoxic ischaemic encephalopathy (HIE)
• cerebral palsy/neurodevelopment al disability/developmental delay/
• neonatal seizures

Include all countries

Exclude case reports and case series with no comparative data

Amniotic fluid to be added as a search term

Low risk women – those without medical or obstetric complications at the onset of labour

Cardiotocography (CTG) Reviewers: note if EFM is continuous as in constant (on all the time) or on and off (e.g. 30 minute intervals of continuous monitoring with breaks)

Need to consider the implications of planned place of birth and need for transfer

• Mode of birth (spontaneous vaginal, unplanned CS, instrumental)
• Postpartum haemorrhage
• Length of hospital stay

• Mortality
• Major neonatal morbidity (GDG to decide – see opposite)
• Requirement for resuscitation at birth
• Need for ventilator support/length of time with ventilator support
• Length of stay in NICU
• Metabolic acidosis at birth (cord pH less than 7.05 and base deficit greater than 12 mmol/l)

• meconium aspiration syndrome
• hypoxic ischaemic encephalopathy (HIE)
• cerebral palsy/neurodevelopment al disability/developmental delay

Include all countries

Exclude case reports and case series with no comparative data

PROTOCOL AS USED IN CG190 (2014) – 2016 EVIDENCE REVIEW TO BE PERFORMED IN ACCORDANCE WITH CG190 METHODS SECTION (1.10.2 AND 1.10.3)

Note: decided that EFM/FHR traces will be called cardiotocographs (CTG) throughout guideline in order to accurately reflect that they record both the fetal heart rate and labour contractions

• Comparative observational studies (cohort, case-control)
• Prognostic/diagnostic studies

• fetal heart rate (FHR)
• FHR pattern/characteristics
• EFM/CTG/FHR interpretation/assessment/analysis
• uterine activity and relation to FHR/CTG characteristics
• baseline heart rate: normal, tachy/bradycardia
• variability in heart
  rate/beat-to-beat
  variability: good
  variability, reduced
  variability, excessive
  variability, saltatory
  variability
• decelerations: early
  decelerations, late
  decelerations, variable
  decelerations, typical and atypical decelerations
• accelerations
• change within/of baseline
• sinusoidal trace
• pseudosinusoidal trace

• Mode of birth

• Mortality
• Major neonatal morbidity (GDG to decide – see opposite)
• Need for ventilator support/length of time with ventilator support
• Admission to NICU
• Cord blood gas values at birth
• Fetal acidosis at birth

• hypoxic ischaemic encephalopathy (HIE)
• cerebral palsy/neurodevelopment al disability
• neonatal seizures
• birth asphyxia
• developmental delay

Include all countries

Exclude case reports

NEW PROTOCOL 2016 – EVIDENCE REVIEW TO BE PERFORMED IN ACCORDANCE WITH CG190 METHODS SECTION (1.10.2 AND 1.10.3); ADDITIONALLY DUAL WEEDING AND STUDY SELECTION (INCLUSION/EXCLUSION) TO BE UNDERTAKEN FOR THIS QUESTION (ANY DISCREPANCIES TO BE RESOLVED THROUGH DISCUSSION BETWEEN THE FIRST AND SECOND REVIEWERS OR BY REFERENCE TO A THIRD PERSON)

Outcome: based on a 10% sample of search results (n=100), there was 86% agreement between reviewers on initial weeding and 100% agreement on study selection (inclusion/exclusion) following resolution of weeding discrepancies

When a cardiotocograph trace reveals signs that cause concern, practical guidance that influences care in labour is needed. The guidance should aim to minimise unnecessary action and interventions, whilst achieving optimal labour outcomes for the woman and baby.

Table 93 in CG190 specifies how care for the woman and her baby should be determined based on findings of the cardiotocograph trace (and other factors). These recommendations were formulated using group consensus in the absence of any formal literature search and no reference to clinical evidence. This review aims to identify evidence that might inform an update of Table 93

A cardiotocography (CTG)-guided intervention protocol designed to improve outcomes for the woman or her baby.

The following may be considered provided they are evaluated in the context of a specific CTG-guided intervention protocol:

• expediting birth (for example, emergency caesarean section or instrumental vaginal birth)
• changing maternal position
• intravenous ephedrine (for example, due to hypotension)
• starting or stopping oxytocin, prostaglandins, beta-adrenergic agonists (for example, terbutaline, salbutamol, ritodrine), nifedipine, atosiban, or nitroglycerine
• oxygen
• fluids (intravenous or oral)
• analgesia
• seeking expert advice
• following usual care
• discontinuing maternal pushing

Management of high temperature in the woman using anti-pyretics will not be considered as the guideline on intrapartum care for high-risk women will cover this.

Fetal blood sampling and fetal scalp stimulation will not be considered as separate review questions in this guideline cover these

• Another CTG-guided intervention protocol
• Usual care

• Extended perinatal death after randomisation (excluding those from congenital anomalies)
• Hypoxic ischaemic encephalopathy (HIE)
• Admission to NICU
• Acidosis (arterial cord pH less than 7.05, base deficit of more than 12)
• Need for fetal blood sampling
• Mode of birth
• Maternal morbidity, for example perineal trauma, postpartum haemorrhage
• Women’s satisfaction/experience of labour and birth including mobility

Groups that will be reviewed and analysed separately:

• classification of cardiotocographic trace results (for example, CTG non-reassuring versus CTG abnormal)

When comparative observational studies are included for intervention reviews the following confounders will be considered:

• antenatal and intrapartum risk factors
• centre

• systematic reviews of randomised controlled trials (RCTs)
• RCTs (including test and treat)
• comparative observational studies (only if RCTs unavailable or limited data to inform decision making)

Sources to be searched: Medline, Medline In-Process, CCTR, CDSR, DARE, HTA, Embase. Limits (for example, date or study design): all study designs; no limits on date of publication. Apply standard animal/non-English language filters.

Supplementary search techniques: none

Appraisal of methodological quality: assess at study level using NICE checklists; assess at outcome level (across studies) using GRADE.

Synthesis of data:

Meta-analysis will be conducted where appropriate.

If comparative cohort studies are included, the minimum number of events per covariate will be recorded to ensure accurate multivariate analysis.

Default minimally important differences (MIDs) will be used: 0.75 and 1.25 for dichotomous outcomes; 0.5 times standard deviation (SD) for continuous outcomes.

If studies report only p-values, this information will be recorded in GRADE tables without an assessment of imprecision being made

FIGO consensus guidelines 2015: cardiotocography

http://www​.sciencedirect​.com/science/article​/pii/S0020729215003951

Holzmann M, Wretler S, Cnattingius S, Nordström L. Neonatal outcome and delivery mode in labors with repetitive fetal scalp blood sampling. Eur J Obstet Gynecol Reprod Biol. 2015 Jan;184:97–102

• Electronic fetal monitoring alone
• Electronic fetal monitoring plus ECG

PROTOCOL AS USED IN CG190 (2014) – 2016 EVIDENCE REVIEW TO BE PERFORMED IN ACCORDANCE WITH CG190 METHODS SECTION (1.10.2 AND 1.10.3)

This will be one search but will then be reviewed with 2, possibly 4, sub-questions depending on the evidence found.

• For predictive value - diagnostic/prognostic studies for predictive value
• For improving clinical outcomes – randomised controlled trials (RCTs). If little RCT evidence then comparative observational studies.
• Both will be reviewed for EFM alone and EFM+ECG

Report details of population including proportion who are high risk.

Do not include studies where all women are a specific high risk population or where a significant proportion (33% or more) are in preterm labour

Stimulation can be digital (with the fingers during a vaginal examination) or with a needle during fetal scalp blood sampling. It is generally done while carrying out another procedure rather than as a single intervention in and of itself – but for research purposes this may not be the case.

Can also include other external methods of fetal stimulation e.g. fibroacoustic

• Electronic fetal monitoring alone
• Electronic fetal monitoring with ECG analysis

• EFM
• cardiotocography (CTG)
• continuous monitoring
• electrocardiogram (ECG)
• ST wave analysis (STAN)

• digital scalp stimulation
• scalp stimulation with a needle/blade
• acceleration (this is what is hoped to be prompted in the fetal heartrate)
• fibroacoustic fetal stimulation

• Mode of birth (and indication if operative birth)
• Women’s satisfaction/experience of labour and birth including mobility
• Need for fetal blood sampling or even failed FBS
• Length of labour

• Mortality
• Major neonatal morbidity (see opposite)
• Admission to NICU
• Cord blood gas values at birth
• Fetal scalp blood gas values during labour
• Trauma/injury to infant

• hypoxic ischaemic encephalopathy (HIE)
• cerebral palsy/neurodevelopment al disability/developmental delay
• neonatal seizures
• birth asphyxia

Include all countries

Exclude case reports

1. Does the use of fetal blood sampling as an adjunct to electronic fetal monitoring (EFM) improve outcomes, when compared to:

   • electronic fetal monitoring alone
   • electronic fetal monitoring plus electrocardiogram (ECG)?
2. What is the optimum time from the decision to perform a fetal blood sample to having the blood result?
3. What is the predictive value of the following measures, for maternal and neonatal outcomes:

   • fetal blood pH analysis
   • fetal blood lactate analysis
   • fetal acid-base status
   • fetal-base deficit?

PROTOCOL AS USED IN CG190 (2014) – 2016 EVIDENCE REVIEW TO BE PERFORMED IN ACCORDANCE WITH CG190 METHODS SECTION (1.10.2 AND 1.10.3)

THESE QUESTIONS WERE PRIORITISED FOR HEALTH ECONOMIC ANALYSIS IN CG190

This will be one search but will then be reviewed as 3 questions.

• Report indication for FBS, and how women have been previously monitored
• Report failure rates of FBS

1. To determine if fetal blood sampling is a useful test to perform during labour to aid decision-making.
2. Does performing fetal blood sampling make a difference to clinical outcomes?
3. Is there a maximum time to get a result beyond which it is not reasonable to take a fetal blood sample?
4. When performing fetal blood sampling, what biochemical analysis should be performed?

1.

Diagnostic/prognostic studies

2.

Randomised controlled trials (RCTs)

3.

If little RCT evidence then comparative observational studies

3.

Observational studies, including non-comparative studies

• women may or may not have an indication for FBS
• any use of oxytocin or induction during labour

Might help to add “intrapartum” to the search to rule out antenatal fetal sampling

Other possible terms for search:

• fetal scalp blood pH
• fetal scalp blood sampling
• lactate measurement
• acid-base difference
• FBS
• base deficit

• Different kind of fetal blood sampling (e.g. lactate versus pH analysis)
• Continuous EFM only (i.e. without fetal blood sampling)
• Continuous EFM plus ECG
• EFM with possibly different times (e.g. <20 minutes versus. > 20 minutes)

• Mode of birth (and indication if operative birth)
• Women’s satisfaction/experience of labour and birth including mobility
• Length of labour
• Trauma (psychological or physical, trauma or distress)

• Mortality
• Major neonatal morbidity (see opposite)
• Apgar score < 7 at 5 minutes
• Admission to NICU
• Cord blood gas values at birth
• Trauma/injury to infant

• hypoxic ischaemic encephalopathy (HIE)
• cerebral palsy/neurodevelopment al disability/developmental delay

Include all countries

Exclude case reports

For question 3, we will restrict studies to those reporting outcomes/predictive value for samples taken within 1 hour of birth.

For questions 3 and 4 report time interval between FBS and birth

For all questions also report Apgar at 1 minute as this was reported in original guideline.

If there is insufficient evidence for women at low risk of complications in labour, include studies with higher risk population

• Qualitative studies – comparative better.
• Trials or comparative observational studies that report women’s experiences

Will include studies where population includes women with complications.

Reviewers: report study population in detail

1. Electronic fetal monitoring/cardiotocography with/without telemetry
2. Electrocardiogram (ECG) analysis
3. Intermittent auscultation
4. Fetal blood sampling

• continuous electronic fetal monitoring (EFM)
• CTG
• ST wave analysis (STAN)
• Doppler fetal monitors (“Sonicaid” - product from the UK company; “Doptone” – US term)
• fetal scalp electrodes
• hand-held ultrasound devices
• Pinard stethoscope
• a fetal stethoscope
• listening in
• no monitoring of fetal heartbeat
• fetal movements
• observation of amniotic fluid/liquor

• Women’s views and experiences of labour and birth
• Emotional and psychological outcomes (e.g. distress, anxiety, reassurance)
• Satisfaction with birth experience and care received

Include all countries

Exclude case reports

Include qualitative studies from all dates

RCTs and comparative observational studies – from date of previous guideline

PROTOCOL AS USED IN CG190 (2014) – 2016 EVIDENCE REVIEW TO BE PERFORMED IN ACCORDANCE WITH CG190 METHODS SECTION (1.10.2 AND 1.10.3)

THIS QUESTION WAS PRIORITISED FOR HEALTH ECONOMIC ANALYSIS IN CG190

Randomised controlled trials (RCTs)

Comparative observational studies (if no RCT data)

• ECG analysis, could include ST wave/segment analysis (STAN) or PR interval analysis
• ECG might be called EKG (the abbreviation for the German word elektrokardiogramm)
• FECG
• T/QRS ratio

This could be fully continuous, or ‘intermittent continuous’

Possible search terms:

• cardiotocography - CTG
• cardiotocogram
• FHR trace interpretation

FHR monitoring

• Mode of birth (spontaneous, Caesarean section, instrumental)
• Women’s satisfaction/experience of labour and birth including mobility
• Need for fetal blood sampling
• Perineal trauma

• Mortality
• Admission to NICU
• Metabolic acidosis at birth (cord pH less than 7.05 and base deficit greater than 12 mmol/l)
• Requirement for resuscitation at birth/assisted ventilation (IPPV)

• meconium aspiration syndrome
• fetal trauma

Document indication for birth

Major neonatal morbidity could include:

• hypoxic ischaemic encephalopathy (HIE)
• cerebral palsy/neurodevelopment al disability/developmental delay

Include all countries

Exclude case reports and case series with no comparative data

NEW PROTOCOL 2016 – EVIDENCE REVIEW TO BE PERFORMED IN ACCORDANCE WITH CG190 METHODS SECTION (1.10.2 AND 1.10.3); ADDITIONALLY DUAL WEEDING AND STUDY SELECTION (INCLUSION/EXCLUSION) TO BE UNDERTAKEN FOR THIS QUESTION (ANY DISCREPANCIES TO BE RESOLVED THROUGH DISCUSSION BETWEEN THE FIRST AND SECOND REVIEWERS OR BY REFERENCE TO A THIRD PERSON)

Outcome: based on a 10% sample of search results (n=62), there was 87% agreement between reviewers on initial weeding and 100% agreement on study selection (inclusion/exclusion) following resolution of weeding discrepancies

• sensitivity
• specificity
• positive likelihood ratio
• negative likelihood ratio
• intra-rater reliability

• extended perinatal death after randomisation (excluding those from congenital anomalies)
• hypoxic ischaemic encephalopathy (HIE)
• admission to NICU
• acidosis (arterial cord pH <7.05, base deficit of more than 12)
• need for fetal blood sampling
• mode of birth
• Women’s satisfaction/experience of labour and birth including mobility

• type of decision-support software

• centre
• software
• training systems (e.g. Baby Lifeline, Prompt)

• systematic reviews of randomised controlled trials (RCTs)
• RCTs (including test and treat)
• cohort studies (only if RCTs unavailable or limited data to inform decision making)
• diagnostic test accuracy studies

Appraisal of methodological quality:

assess at study level using NICE checklists;

assess at outcome level (across studies) using GRADE.

Synthesis of data:

meta-analysis will be conducted where appropriate.

If cohort studies are included, the minimum number of events per covariate will be recorded to ensure accurate multivariate analysis.

Default minimally important differences (MIDs) will be used: 0.75 and 1.25 for dichotomous outcomes; 0.5 times standard deviation (SD) for continuous outcomes.

If studies report only p-values, this information will be recorded in GRADE tables without an assessment of imprecision being made

INFANT study, due to publish during 2016:

https://www​.ucl.ac.uk/ictm/about/cctu

FM ALERT, Ayres-De-Campos (1^st author) presented at European conference ECIC, Porto, 2015

Six studies included in CG190 (based on 2007 guideline) without a published review question or protocol:

• [reference 495] Keith RD, Beckley S, Garibaldi JM, et al. A multicentre comparative study of 17 experts and an intelligent computer system for managing labour using the cardiotocogram. BJOG: an international journal of obstetrics & gynaecology. 1995;102(9):688–700.
• [reference 496] Taylor GM, Mires GJ, Abel EW, et al. The development and validation of an algorithm for real-time computerised fetal heart rate monitoring in labour. BJOG: an international journal of obstetrics & gynaecology. 2000;107(9):1130–7.
• [reference 497] Todros T, Preve CU, Plazzotta C, et al. Fetal heart rate tracings: observers versus computer assessment. European Journal of Obstetrics, Gynecology and Reproductive Biology. 1996;68(1–2):83–6.
• [reference 498] Chung TK, Mohajer MP, Yang ZJ, et al. The prediction of fetal acidosis at birth by computerised analysis of intrapartum cardiotocography. BJOG: an international journal of obstetrics & gynaecology. 1995;102(6):454–60.
• [reference 499] Nielsen PV, Stigsby B, Nickelsen C, et al. Computer assessment of the intrapartum cardiotocogram. II. The value of computer assessment compared with visual assessment. Acta Obstetricia et Gynecologica Scandinavica. 1988;67(5):461–4.
• [reference 500] Mongelli M, Dawkins R, Chung T, et al. Computerised estimation of the baseline fetal heart rate in labour: the low frequency line. BJOG: an international journal of obstetrics & gynaecology. 1997;104(10):1128–33.