2.1. Background
The Medical eligibility criteria for contraceptive use (MEC) provides guidance regarding which clients can use contraceptive methods safely. The goal of the document is to improve access to, and quality of, family planning services by providing policy-makers, decision-makers and the scientific community with recommendations that can be used for developing or revising national guidelines on the medical eligibility criteria for the use of specific contraceptive methods. Methods covered by this guidance include all hormonal contraceptives, intrauterine devices, barrier methods, fertility awareness-based methods, coitus interruptus, lactational amenorrhoea method, male and female sterilization, and emergency contraception. These evidence-based recommendations do not indicate a “best” method that should be used in a particular medical context; rather, review of the recommendations allows for consideration of multiple methods that could be used safely by people with certain health conditions (e.g. hypertension) or relevant characteristics (e.g. age).
2.1.1. Reproductive and sexual health care as a human right
The Programme of Action of the International Conference on Population and Development (ICPD) defines reproductive health as: “a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity, in all matters relating to the reproductive system and to its functions and processes”1. The Programme of Action also states that the purpose of sexual health “is the enhancement of life and personal relations, and not merely counselling and care related to reproduction and sexually transmitted diseases”. Recognizing the importance of agreements made at the ICPD and other international conferences and summits, the Beijing Declaration and Platform for Action defines reproductive rights in the following way:
Reproductive rights embrace certain human rights that are already recognized in national laws, international human rights documents and other relevant consensus documents. These rights rest on the recognition of the basic right of all couples and individuals to decide freely and responsibly the number and spacing and timing of their children and to have the information and means to do so, and the right to attain the highest standard of sexual and reproductive health.2
Among the Millennium Development Goals (MDGs) agreed by states in 2001, target 5b calls for universal access to reproductive health by 2015. Reproductive and sexual health care, including family planning services and information, is recognized not only as a key intervention for improving the health of men, women and children but also as a human right. International and regional human rights treaties, national constitutions and laws provide guarantees specifically relating to access to contraceptive information and services. These include the guarantee that states should ensure timely and affordable access to good quality sexual and reproductive health information and services, including contraception, which should be delivered in a way that ensures fully informed decision-making, respects dignity, autonomy, privacy and confidentiality, and is sensitive to individuals' needs and perspectives in a client–provider partnership.3 A rights-based approach to the provision of contraceptives assumes a holistic view of clients, which includes taking into account clients' sexual and reproductive health care needs and considering all appropriate eligibility criteria when helping clients choose and use a family planning method safely.
Evidence shows that the respect, protection and fulfilment of human rights contribute to positive health outcomes. The provision of contraceptive information and services that respect individual privacy, confidentiality and informed choice, along with a wide range of safe contraceptive methods, increase people's satisfaction and continued use of contraception.4 5 6 7
Delivery of care in accordance with the client's human and reproductive rights is fundamental to quality of care. The development of international norms for medical eligibility criteria and practice recommendations for contraceptive use is only one aspect of improving the quality of reproductive health care. Many family planning programmes have included screening, treatment and follow-up procedures that reflect high standards of public health and clinical practice, but these should not be seen as eligibility requirements for specific contraceptive methods. These procedures include the screening and treatment of cervical cancer, anaemia and sexually transmitted infections (STIs), and the promotion of breastfeeding and cessation of smoking. Such procedures should be strongly encouraged if the human and material resources are available to carry them out, but they should not be seen as prerequisites for the acceptance and use of family planning methods since they are not necessary to establish eligibility for the use or continuation of a particular method.
2.1.2. Contraceptive choice
While this document primarily addresses medical eligibility criteria for contraceptive use, considerations of social, behavioural and other non-medical criteria – particularly client preference – must also be taken into account. To provide contraceptive choices to clients in a way that respects and fulfils their human rights necessitates enabling clients to make informed choices for themselves. Women's choices, however, are often taken away from them or limited by direct or indirect social, economic and cultural factors. From a woman's point of view, her choices are made at a particular time, in a particular societal and cultural context; choices are complex, multifactorial and subject to change. Decision-making regarding contraceptive methods usually requires the need to make trade-offs among the advantages and disadvantages of different methods, and these vary according to individual circumstances, perceptions and interpretations. Factors to consider when choosing a particular contraceptive method include the characteristics of the potential user, the baseline risk of disease, the adverse effects profile of different products, cost, availability and patient preferences.
This document does not provide recommendations about which specific product or brand to use after selecting a particular type of contraceptive method. Instead, it provides guidance for whether women with specific medical conditions or medically relevant physiological or personal characteristics are eligible to use various contraceptive methods. Decisions about what methods to use should also take into account clinical judgment and user preferences.
Issues of service quality and access that affect method use and choice
The following service-delivery criteria are universally relevant to the initiation and follow-up of all contraceptive method use:
- Clients should be given adequate information to help them make an informed, voluntary choice of a contraceptive method. This information should at least include:
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the relative effectiveness of the method;
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correct usage of the method;
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how it works;
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common side-effects;
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health risks and benefits of the method;
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signs and symptoms that would necessitate a return to the clinic;
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information on return to fertility after discontinuing method use; and
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information on STI protection.
Information should be presented using language and formats that can be easily understood and accessed by the client. - In order to offer methods that require surgical approaches, insertion, fitting and/or removal by a trained health-care provider (i.e. sterilization, implants, IUDs, diaphragms, cervical caps), appropriately trained personnel in adequately equipped and accessible facilities must be available, and appropriate infection-prevention procedures must be followed.
- Adequate and appropriate equipment and supplies need to be maintained and held in stock (e.g. contraceptive commodities, and supplies for infection-prevention procedures).
- Service providers should be provided with guidelines, client cards or other screening tools.
2.1.3. Effectiveness of method
Contraceptive choice is in part dependent on the effectiveness of the contraceptive method in preventing unplanned pregnancy, which, in turn, is dependent for some methods not only on the protection afforded by the method itself, but also on how consistently and correctly it is used. Table 2.1 compares the percentage of women experiencing an unintended pregnancy during the first year of contraceptive method use when the method is used perfectly (consistently and correctly) and when it is used typically (assuming occasional non-use and/or incorrect use). Consistent and correct usage can both vary greatly with client characteristics such as age, income, desire to prevent or delay pregnancy, and culture. Methods that depend on consistent and correct usage by clients (e.g condoms and pills) have a wide range of effectiveness. Most men and women tend to be more effective users as they become more experienced with a method. However, programmatic aspects also have a profound effect on how effectively (consistently and correctly) the method will be used.
2.1.4. Conditions that expose a woman to increased risk as a result of unintended pregnancy
Women with conditions that may make unintended pregnancy an unacceptable health risk should be advised that, because of their relatively higher typical-use failure rates, sole use of barrier methods for contraception and behaviour-based methods of contraception may not be the most appropriate choice for them. These conditions are noted in Box 2.1.
2.1.5. Return to fertility
Among contraceptive methods, only male and female sterilization are regarded as irreversible (or permanent). All other methods are reversible, usually with prompt return to fertility upon method discontinuation, with the exception of depot medroxyprogesterone acetate (DMPA) and norethisterone enanthate (NET-EN). The median delay in return to fertility with these methods is 10 and 6 months, respectively, from the date of the last injection, regardless of the duration of their use. Male and female sterilization should be regarded as permanent methods (no possibility of future childbearing), and all individuals and couples considering these methods should be counselled accordingly. No other methods result in permanent infertility.
2.1.6. STIs and contraception: dual protection
In addition to the imperative of international norms for contraceptive provision to assure quality of care in services, the social, cultural and behavioural context of each client must also be considered. In this regard, the problems of exposure to STIs, including HIV, deserve special consideration because of the equal importance of preventing pregnancy and preventing transmission of infections among sexually active clients of reproductive age. When a risk of HIV and other STI transmission exists,8 it is important that health-care providers offer information on safer sexual practices to prevent transmission and strongly recommend dual protection to all persons at significant risk, either through the simultaneous use of condoms with other methods or through the consistent and correct use of condoms alone for prevention of both pregnancy and STIs, including HIV. Women and men seeking contraceptive advice must always be reminded of the importance of condom use for preventing the transmission of STI/HIV and such use should be encouraged and facilitated where appropriate. When used correctly and consistently, condoms offer one of the most effective methods of protection against STIs, including HIV. Female condoms are effective and safe, but are not used as widely by national programmes as male condoms.
2.2. How to use this document
The present document is intended for use by policy-makers, family planning programme managers and the scientific community. It aims to provide guidance to national family planning and reproductive health programmes in the preparation of guidelines for delivery of contraceptive services. It is not meant to serve as the actual guidelines but rather as a reference.
The guidance in this document is intended for interpretation at country and programme levels in a manner that reflects the diversity of situations and settings in which contraceptives are provided. While it is unlikely that the classification of categories in this document would change during this process, it is very likely that the application of these categories at country level will vary. In particular, the level of clinical knowledge and experience of various types of providers and the resources available at the service-delivery point will have to be taken into consideration.
Recommendations are presented in tables according to the contraceptive methods included in the guidance with each condition. Each condition was defined as representing either a known pre-existing medical/pathological condition (e.g. diabetes, hypertension) or a medically relevant individual characteristic (e.g. age, history of pregnancy).
It is expected that national and institutional health-care and service-delivery environments will decide the most suitable means for screening for conditions according to their public health importance. Client history will often be the most appropriate approach. A family planning provider may want to consult an expert in the underlying condition.
Initiation and continuation
The medical eligibility criteria for the initiation and continuation of all contraceptive methods are used in the evaluation of eligibility. The assessment of continuation criteria is clinically relevant whenever a woman develops the condition while she is using the method. Where medical eligibility for initiation and continuation of a contraceptive method differ, these differences are noted in the columns of the tables for each contraceptive method (I = initiation; C = continuation). Where I and C are not denoted, the category is the same for initiation and continuation of use.
As shown in Table 2.2 in a simplified template of the tables for each contraceptive (provided in section 2.7), the first column indicates the conditions (each in a separate row). Several conditions are subdivided to differentiate between varying degrees of the condition. The second column classifies the condition for initiation and/or continuation into one of the four MEC categories, as described in section 2.3. The third column provides space for any necessary clarifications or presentation of evidence regarding the classification
2.3. Using the categories in practice
Categories 1 and 4 are self-explanatory. Classification of a method/condition as Category 2 indicates the method can generally be used, but careful follow-up may be required. However, provision of a method to a woman with a condition classified as Category 3 requires careful clinical judgement and access to clinical services; for such a woman, the severity of the condition and the availability, practicality and acceptability of alternative methods should be taken into account. For a method/condition classified as Category 3, use of that method is not usually recommended unless other more appropriate methods are not available or acceptable. Careful follow-up will be required.
Where resources for clinical judgment are limited, such as in community-based services, the four-category classification framework can be simplified into two categories. With this simplification, a classification of Category 1 or 2 indicate that a woman can use a method, and a classification of Category 3 or 4 indicate that a woman is not medically eligible to use the method (see Table 2.3).
2.4. Programmatic implications
The following issues need to be addressed when applying the medical eligibility criteria in this document to programmes:
- informed choice
- elements of quality of care
- essential screening procedures for administering the methods
- provider training and skills
- referral and follow-up for contraceptive use as appropriate.
Service-delivery practices that are essential for the safe use of the particular contraceptive method should be distinguished from practices that may be appropriate for good health care but are not related to use of the method. The promotion of good health-care practices unrelated to safe contraception should be considered neither as a prerequisite nor as an obstacle to the provision of a contraceptive method, but as complementary to it.
As a next step, the recommendations on medical eligibility criteria need to be considered in light of the country context, so as to be applicable to providers at all levels of the service-delivery system. It is expected that national and institutional health-care and service-delivery environments will decide the most suitable means for screening for conditions according to their public health importance. Client history will often be the most appropriate approach. A family planning provider may want to consult an expert in the underlying condition. Countries will need to determine how far and by what means it may be possible to extend their services to the more peripheral levels of the health system. This may involve upgrading both staff and facilities where feasible and affordable, or it may require or a modest addition of equipment and supplies, and redeployment of space. It will also be necessary to address misperceptions sometimes held by providers and users about the risks and side-effects of particular methods, and to look closely at the needs and perspectives of women and men in the context of informed choice.
Adaptation is not always an easy task and is best done by those well acquainted with prevailing health conditions, behaviours and cultures. These improvements must be made within the context of users' informed choices and medical safety.
2.5. Clients with special needs
2.5.1. People with disabilities
According to United Nations Convention on the Rights of Persons with Disabilities (CRPD), people with disabilities must have access, on an equal basis with others, to all forms of sexual and reproductive health care (Article 25) as part of the general right to marry, found a family and retain their fertility (Article 23)9. Health-care professionals often fail to offer sexual and reproductive health services to people with disabilities, based on the common misconception that they are not sexually active.10 Provision of contraceptive services to people with disabilities may, however, require decisions regarding appropriate contraception considering the preferences of the individual, the nature of the disability and the specifics of different conceptive methods.
For example, some barrier methods may be difficult to use for those with limited manual dexterity; COCs may not be an appropriate method for women with impaired circulation or immobile extremities, even in the absence of known thrombogenic mutations, because of concerns about an increased risk of DVT; and other methods will be preferable for individuals with intellectual or mental health disabilities who have difficulty remembering to take daily medications. For women who have difficulty with menstrual hygiene, the impact of the contraceptive method on menstrual cycles should also be considered.
In all instances, medical decisions must be based upon informed choice, based on adequate sexual and reproductive health education. When the nature of the disability makes it more challenging to discern the will and preferences of the individual, contraceptives should only be provided in a manner consistent with Article 12 of the CRPD. Specifically, in such cases a process of supported decision-making should be instituted in which individuals who are trusted by the individual with disabilities, personal ombudsman and other support persons jointly participate with the individual in reaching a decision that is, to the greatest extent possible, consistent with the will and preference of that individual. Given the history of involuntary sterilization of persons with disabilities, often as a technique for menstrual management in institutions,11 it is especially important to ensure that decisions about sterilization are only made with the full, uncoerced and informed consent of the individual, either alone or with support.
2.5.2. Adolescents
Adolescents in many countries lack adequate access to contraceptive information and services that are necessary to protect their sexual and reproductive health. There is an urgent need to implement programmes that both meet the contraceptive needs of adolescents and remove barriers to services. In general, adolescents are eligible to use all the same methods of contraception as adults, and must have access to a variety of contraceptive choices. Age alone does not constitute a medical reason for denying any method to adolescents. While some concerns have been expressed about the use of certain contraceptive methods by adolescents (e.g. the use of progestogen-only injectables by those below 18 years), these concerns must be balanced against the advantages of preventing unintended pregnancy. It is clear that many of the same eligibility criteria that apply to older clients also apply to young people. However, some conditions (e.g. cardiovascular disorders) that may limit the use of some methods in older women do not generally affect young people, since these conditions are rare in this age group.
Political and cultural factors may affect adolescents' ability to access contraceptive information and services. For example, where contraceptive services are available, adolescents (in particular unmarried ones) may not be able to obtain them because of restrictive laws and policies. Even if adolescents are able to obtain contraceptive services, they may not do so because of fear that their confidentiality will not be respected, or that health workers may be judgmental. All adolescents, regardless of marital status, have a right to privacy and confidentiality in health matters, including reproductive health care. Appropriate sexual and reproductive health services, including contraception, should be available and accessible to all adolescents without necessarily requiring parental or guardian authorization by law, policy or practice.
Social and behavioural issues should be key considerations in the choice of contraceptive methods by adolescents. For example, in some settings, adolescents are also at increased risk for STIs, including HIV. While adolescents may choose to use any one of the contraceptive methods available in their communities, in some cases, using methods that do not require a daily regimen may be more convenient. Adolescents, married or unmarried, have also been shown to be less tolerant of side-effects and therefore have high discontinuation rates. Method choice may also be influenced by factors such as sporadic patterns of intercourse and the need to conceal sexual activity and contraceptive use. For instance, sexually active adolescents who are unmarried have very different needs from those who are married and want to postpone, space or limit pregnancy. Expanding the number of method choices offered can lead to improved satisfaction, increased acceptance and increased prevalence of contraceptive use. Proper education and counselling – both before and at the time of method selection – can help adolescents address their particular needs and make informed and voluntary decisions. Every effort should be made to prevent the costs of services and/or methods from limiting the options available.
2.6. Summary of changes within the MEC fifth edition
The following tables highlight changes within the fifth edition of the MEC, compared with the fourth edition (see Tables 2.4–2.6). These changes include: changes to MEC categories between the earlier editions and the fifth edition; recommendations for new conditions issued in the fifth edition; changes to the labelling of certain conditions (in order to be consistent with current clinical practice); and details for the new contraceptive methods included in this fifth edition.
2.7. Tables
2.7.1. Combined hormonal contraceptives (CHCs)
COMBINED ORAL CONTRACEPTIVES (COCs)
The recommendations in this guidance refer to low-dose COCs containing ≤ 35 mcg ethinyl estradiol combined with a progestogen.
Venous thrombosis is rare among women of reproductive age. All COCs are associated with an increased risk for venous thromboembolism (VTE) compared to non-use. A number of studies have found differences in risk for VTE associated with COCs containing different types of progestogens (1–19). Current evidence suggests that COCs containing levonorgestrel, norethisterone and norgestimate are associated with the lowest risk (20). The absolute differences, however, are very small.
Limited data do not suggest that the small absolute risk for arterial events associated with COC use varies according to the type of progestogen (5, 6, 20–34).
Recommendations in this guidance are the same for all COC formulations, irrespective of their progestogen content.
COMBINED INJECTABLE CONTRACEPTIVES (CICs)
Two CIC formulations, are considered here:
- Cyclofem = medroxyprogesterone acetate 25 mg plus estradiol cypionate 5 mg
- Mesigyna = norethisterone enanthate 50 mg plus estradiol valerate 5 mg
CICs contain the naturally occurring estrogen, estradiol plus a progestogen (35–39). Estradiol is less potent, has a shorter duration of effect and is more rapidly metabolized than the synthetic estrogens used in other contraceptive formulations such as COCs, the combined contraceptive patch (P) and the combined contraceptive vaginal ring (CVR). These differences imply that the type and magnitude of estrogen-related side-effects associated with CICs may be different from those experienced by COC/P/CVR users. In fact, short-term studies of CICs have shown little effect on blood pressure, haemostasis and coagulation, lipid metabolism and liver function in comparison with COCs (40–42). As CICs are administered by injection, the first-pass metabolism by the liver is avoided, thereby minimizing estradiol's effect on the liver.
However, CICs are a relatively new contraceptive method, and there are few epidemiological data on their long-term effects. There is also the concern that, while the effect of the hormonal exposure associated with use of COCs and progestogen-only pills (POPs) can be reduced immediately by discontinuing their use, this is not the case with injectables, for which the effect continues for some time after the last injection.
Pending further evidence, the Guideline Development Group (GDG) concluded that the evidence available for COCs applies to CICs in many but not all instances. Therefore, the GDG assigned categories for CICs somewhere between the categories for COCs and POPs. However, for severe pathologies (e.g. ischaemic heart disease), the classification of conditions was the same as for COCs. The assigned categories should, therefore, be considered a preliminary, best judgement, which will be re-evaluated as new data become available.
COMBINED CONTRACEPTIVE PATCH (P) AND COMBINED CONTRACEPTIVE VAGINAL RING (CVR)
The combined contraceptive patch (P) and combined vaginal ring (CVR) are relatively new contraceptive methods. Limited information is available on the safety of these methods among women with specific medical conditions. Moreover, epidemiological data on the long-term effects of P and CVR use were not available for the GDG to review. Most of the available studies received support from the manufacturers of these methods.
According to available evidence, the P provides a comparable safety and pharmacokinetic profile to COCs with similar hormone formulations (43–60). Reports of transient, short-term breast discomfort and skin-site reactions were greater among P users; however, less than 25% of users experienced these events (45, 49, 50, 56–58, 61). Limited evidence suggests the effectiveness of the P may decline for women weighing 90 kg or more (58, 60).
According to available evidence, the CVR provides a comparable safety and pharmacokinetic profile and has similar effects on ovarian function to COCs with similar hormone formulations in healthy women (61–75). Evidence from use in obese women (BMI ≥ 30 kg/m2) found that weight gain for women in this category was not different between CVR users and COC users (76). Limited evidence from use in women post medical and surgical abortion found no serious adverse events and no infection related to use during three cycles of follow-up post-abortion (77), and limited evidence on women with low-grade squamous intraepithelial lesions found that use of the vaginal ring did not worsen the condition (64).
Pending further evidence, the GDG concluded that the evidence available for COCs applies to the combined contraceptive P and CVR, and therefore the P and CVR should have the same categories as COCs. The assigned categories should, therefore, be considered a preliminary, best judgement, which will be re-evaluated as new data become available.
RECOMMENDATIONS REVIEWED FOR FIFTH EDITION
These recommendations were reviewed according to WHO requirements for guideline development, as part of the preparation of the Medical eligibility criteria for contraceptive use, fifth edition. The Population, Intervention, Comparator, Outcome (PICO) questions developed by the Guideline Development Group (GDG) and the databases searched to retrieve the evidence, which guided the preparation of systematic reviews, are described in greater detail in Part I of this document. Additionally, GRADE evidence profiles, the overall GRADE assessment of the quality of the evidence, summaries of the evidence supporting the recommendation(s), and other supplementary remarks from the GDG regarding the recommendations, are available in Part I.
ADDITONAL COMMENTS
AGE
Age ≥ 40 years: The risk of cardiovascular disease increases with age and may also increase with combined hormonal contraceptive (CHC) use. In the absence of other adverse clinical conditions, CHCs can be used until menopause.
PAST ECTOPIC PREGNANCY
The risk of future ectopic pregnancy is increased in these women. CHCs provide protection against pregnancy in general, including ectopic gestation.
DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM
Family history of DVT/PE (first-degree relatives): Some conditions which increase the risk of DVT/PE are heritable.
VALVULAR HEART DISEASE
Among women with valvular heart disease, CHC use may further increase the risk of arterial thrombosis; women with complicated valvular heart disease are at greatest risk.
HEADACHES
Aura is a specific focal neurologic symptom. For more information on this and other diagnostic criteria, see: Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders, 2nd edition. Cephalalgia. 2004;24(Suppl 1):1–150.12
VAGINAL BLEEDING PATTERNS
Irregular menstrual bleeding patterns are common among healthy women.
UNEXPLAINED VAGINAL BLEEDING
There are no conditions that cause vaginal bleeding that will be worsened in the short term by use of CHCs.
CERVICAL ECTROPION
Cervical ectropion is not a risk factor for cervical cancer, and there is no need for restriction of CHC use.
CERVICAL CANCER (AWAITING TREATMENT)
There is some theoretical concern that CHC use may affect prognosis of the existing disease. While awaiting treatment, women may use CHCs. In general, treatment of this condition renders a woman sterile.
BREAST DISEASE
Breast cancer: Breast cancer is a hormonally sensitive tumour, and the prognosis of women with current or recent breast cancer may worsen with CHC use.
ENDOMETRIAL CANCER
COC use reduces the risk of developing endometrial cancer.
Awaiting treatment: Women may use COCs, CICs, P or CVR. In general, treatment of this condition renders a woman sterile.
OVARIAN CANCER
COC use reduces the risk of developing ovarian cancer.
Awaiting treatment: Women may use COCs, CICs, P or CVR. In general, treatment of this condition renders a woman sterile.
UTERINE FIBROIDS
COCs do not appear to cause growth of uterine fibroids, and CICs, P and CVR are not expected to either.
PELVIC INFLAMMATORY DISEASE (PID)
COCs may reduce the risk of PID among women with STIs, but do not protect against HIV or lower genital tract STIs. Whether CICs, P or CVR reduce the risk of PID among women with STIs is unknown but they do not protect against HIV or lower genital tract STIs.
GALL BLADDER DISEASE
COCs, CICs, P or CVR may cause a small increased risk of gall bladder disease.
There is also concern that COCs, CICs, P or CVR may worsen existing gall bladder disease.
Unlike COCs, CICs have been shown to have minimal effect on liver function in healthy women, and have no first-pass effect on the liver.
HISTORY OF CHOLESTASIS
Pregnancy-related: History of pregnancy-related cholestasis may predict an increased risk of developing COC-related cholestasis.
Past-COC-related: History of COC-related cholestasis predicts an increased risk with subsequent COC use.
LIVER TUMOURS
There is no evidence regarding hormonal contraceptive use among women with hepatocellular adenoma.
COC use in healthy women is associated with development and growth of hepatocellular adenoma.
THALASSAEMIA
There is anecdotal evidence from countries where thalassaemia is prevalent that COC use does not worsen the condition.
IRON-DEFICIENCY ANAEMIA
CHC use may decrease menstrual blood loss.
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2.7.2. Progestogen-only contraceptives (POCs)
PROGESTOGEN-ONLY PILLS (POPs)
POPs contain only a progestogen and no estrogen.
PROGESTOGEN-ONLY INJECTABLES (POIs)
These injectables include depot medroxyprogesterone acetate (DMPA) and norethisterone enanthate (NET-EN).
There are three formulations considered here:
- DMPA-IM = 150 mg of DMPA given intramuscularly
- DMPA-SC = 104 mg of DMPA given subcutaneously
- NET-EN = 200 mg of NET-EN given intramuscularly
Identified evidence for the conditions of age, obesity, endometriosis and HIV among DMPA-SC users appear consistent with existing recommendations for DMPA-IM (1–12). Further, DMPA-SC and DMPA-IM appear to be therapeutically equivalent, with similar safety profiles when used by healthy women (3, 5, 11). Pending further evidence, the Guideline Development Group (GDG) concluded that the evidence available for DMPA-IM applies to DMPA-SC and, therefore, DMPA-SC should have the same categories as DMPA-IM; the assigned recommendations should be considered a preliminary best judgement, which will be re-evaluated as new data become available.
PROGESTOGEN-ONLY IMPLANTS
Progestogen-only implants are a type of long-acting, reversible contraception. The various types of implants that are considered here are the following:
- Levonorgestrel (LNG): The LNG-containing implants are Norplant®, Jadelle® and Sino-implant (II)®.
- Norplant® is a 6-rod implant, each rod containing 36 mg of LNG (no longer in production).
- Jadelle® is a 2-rod implant, each rod containing 75 mg of LNG
- Sino-implant (II) ® is a 2-rod implant, each rod containing 75 mg of LNG
- Etonogestrel (ETG): The ETG-containing implants are Implanon® and Nexplanon®. Both consist of a single-rod implant containing 68 mg of ETG.
No studies were identified that provided direct evidence on the use of the Sino-implant (II) among women with medical conditions in the MEC and included a comparison group. Evidence from three studies of healthy women demonstrate that Sino-implant (II) has a similar safety and pharmacokinetic profile to that of other LNG implants, with no significant differences in serious adverse events, such as ectopic pregnancy or discontinuation due to medical problems (13–15). Therefore, safety data from studies of other LNG implants among women with medical conditions were used due to the similarity of Sino-implant (II) and other LNG implants in hormone formulation, quality profile and daily release rates. The GDG assigned the same recommendations for Sino-implant (II) as for the other LNG implants.
RECOMMENDATIONS REVIEWED FOR FIFTH EDITION
These recommendations were reviewed according to WHO requirements for guideline development, as part of the preparation of the Medical eligibility criteria for contraceptive use, fifth edition. The Population, Intervention, Comparator, Outcome (PICO) questions developed by the Guideline Development Group (GDG) and the databases searched to retrieve the evidence, which guided the preparation of systematic reviews, are described in greater detail in Part I of this document. Additionally, GRADE evidence profiles, the overall GRADE assessment of the quality of the evidence, summaries of the evidence supporting the recommendation(s), and other supplementary remarks from the GDG regarding the recommendations, are available in Part I.
ADDITIONAL COMMENTS
PAST ECTOPIC PREGNANCY
POPs have a higher absolute rate of ectopic pregnancy compared with other POCs, but still less than using no method. The 75 μg desogestrel-containing pill inhibits ovulation in most cycles, which suggests a low risk of ectopic pregnancy.
HYPERTENSION
Vascular disease: There is concern regarding hypo-estrogenic effects and reduced high-density lipoprotein (HDL) levels, particularly among users of DMPA and NET-EN. However, there is little concern about these effects with regard to POPs or LNG/ETG implants. The effects of DMPA and NET-EN may persist for some time after discontinuation.
DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM
Women on anticoagulation therapy who have a history of haemorrhagic ovarian cysts may benefit from DMPA use.
CURRENT AND HISTORY OF ISCHAEMIC HEART DISEASE
There is concern regarding hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA and NET-EN. However, there is little concern about these effects with regard to POPs or LNG/ETG implants. The effects of DMPA and NET-EN may persist for some time after discontinuation.
STROKE
There is concern regarding hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA and NET-EN. However, there is little concern about these effects with regard to POPs or LNG/ETG implants. The effects of DMPA and NET-EN may persist for some time after discontinuation.
SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Severe thrombocytopenia increases the risk of bleeding. POCs may be useful in the treatment of menorrhagia in women with severe thrombocytopenia. However, given the increased or erratic bleeding that may be seen on initiation of DMPA and its irreversibility for 11–13 weeks after administration, initiation of this method in women with severe thrombocytopenia should be done with caution.
HEADACHES
Aura is a specific focal neurologic symptom. For more information on this and other diagnostic criteria, see: Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders, 2nd edition. Cephalalgia. 2004;24(Suppl 1):1–150.13
There is concern that severe headaches may increase with use of NET-EN, DMPA and implants. The effects of NET-EN and DMPA may persist for some time after discontinuation.
VAGINAL BLEEDING PATTERNS
Irregular menstrual bleeding patterns are common among healthy women. POC use frequently induces an irregular bleeding pattern. Implant use may induce irregular bleeding patterns, especially during the first 3–6 months, but these patterns may persist longer. ETG users are more likely than LNG users to develop amenorrhoea.
UNEXPLAINED VAGINAL BLEEDING
POCs may cause irregular bleeding patterns, which may mask symptoms of underlying pathology. The effects of DMPA and NET-EN may persist for some time after discontinuation.
CERVICAL CANCER (AWAITING TREATMENT)
There is some theoretical concern that POC use may affect prognosis of the existing disease. While awaiting treatment, women may use POCs. In general, treatment of this condition renders a woman sterile.
BREAST DISEASE
Breast cancer: Breast cancer is a hormonally sensitive tumour, and the prognosis of women with current or recent breast cancer may worsen with POC use.
ENDOMETRIAL CANCER
While awaiting treatment, women may use POCs. In general, treatment of this condition renders a woman sterile.
OVARIAN CANCER
While awaiting treatment, women may use POCs. In general, treatment of this condition renders a woman sterile.
UTERINE FIBROIDS
POCs do not appear to cause growth of uterine fibroids.
PELVIC INFLAMMATORY DISEASE (PID)
Whether POCs, like COCs, reduce the risk of PID among women with STIs is unknown, but they do not protect against HIV or lower genital tract STIs.
DIABETES
Nephropathy/retinopathy/neuropathy, other vascular disease, or diabetes of > 20 years' duration: There is concern regarding hypo-estrogenic effects and reduced HDL levels, particularly among users of DMPA and NET-EN. The effects of DMPA and NET-EN may persist for some time after discontinuation. Some POCs may increase the risk of thrombosis, although this increase is substantially less than with COCs.
HISTORY OF CHOLESTASIS
Theoretically, a history of COC-related cholestasis may predict subsequent cholestasis with POC use. However, this has not been documented.
LIVER TUMOURS
There is no evidence regarding hormonal contraceptive use among women with hepatocellular adenoma.
Given that COC use in healthy women is associated with development and growth of hepatocellular adenoma, it is not known whether other hormonal contraceptives have similar effects.
IRON-DEFICIENCY ANAEMIA
Changes in the menstrual pattern associated with POC use have little effect on haemoglobin levels.
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2.7.3. Emergency contraceptive pills (ECPs)
RECOMMENDATIONS REVIEWED FOR FIFTH EDITION
These recommendations were reviewed according to WHO requirements for guideline development, as part of the preparation of the Medical eligibility criteria for contraceptive use, fifth edition. The population, intervention, comparator, outcome (PICO) questions developed by the Guideline Development Group (GDG) and the databases searched to retrieve the evidence, which guided the preparation of systematic reviews, are described in greater detail in Part I of this document. Additionally, GRADE evidence profiles, the overall GRADE assessment of the quality of the evidence, summaries of the evidence supporting the recommendation(s), and other supplementary remarks from the GDG regarding the recommendations, are available in Part I.
ADDITIONAL COMMENTS
History of severe cardiovascular disease, migraine, and severe liver disease (including jaundice)
The duration of use of ECPs is less than that of regular use of COCs or POPs and thus would be expected to have a lower risk for adverse health outcomes.
Rape
There are no restrictions for the use of ECPs in cases of rape.
References
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2.7.4. Intrauterine devices (IUDs)
RECOMMENDATIONS REVIEWED FOR FIFTH EDITION
These recommendations were reviewed according to WHO requirements for guideline development, as part of the preparation of the Medical eligibility criteria for contraceptive use, fifth edition. The population, intervention, comparator, outcome (PICO) questions developed by the Guideline Development Group (GDG) and the databases searched to retrieve the evidence, which guided the preparation of systematic reviews, are described in greater detail in Part I of this document. Additionally, GRADE evidence profiles, the overall GRADE assessment of the quality of the evidence, summaries of the evidence supporting the recommendation(s), and other supplementary remarks from the GDG regarding the recommendations, are available in Part I.
ADDITIONAL COMMENTS
Puerperal sepsis
Insertion of an iud may substantially worsen the condition.
Post-abortion
Immediate post-septic abortion: insertion of an iud may substantially worsen the condition.
Past ectopic pregnancy
The absolute risk of ectopic pregnancy is extremely low due to the high effectiveness of iuds. However, when a woman becomes pregnant during iud use, the relative likelihood of ectopic pregnancy is greatly increased.
Hypertension
There is theoretical concern about the effect of levonorgestrel (LNG) on lipids. There is no restriction for copper-bearing IUDs (Cu-IUDs).
Deep vein thrombosis/pulmonary embolism
The LNG-IUD may be a useful treatment for menorrhagia in women on chronic anticoagulation therapy.
Current and history of ischaemic heart disease
There is theoretical concern about the effect of LNG on lipids. There is no restriction for Cu-IUDs.
Stroke
There is theoretical concern about the effect of LNG on lipids. There is no restriction for Cu-IUDs.
Headaches
Aura is a specific focal neurologic symptom. For more information on this and other diagnostic criteria, see: headache classification subcommittee of the international headache society. The international classification of headache dis-orders, 2nd edition. Cephalalgia. 2004;24(Suppl 1):1–150.14
Severe dysmenorrhoea
Dysmenorrhoea may intensify with Cu-IUD use. LNG-IUD use has been associated with reduction of dysmenorrhoea.
Cervial intraepithelial neoplasia (CIN)
There is some theoretical concern that LNG-IUDs may hasten the progression of CIN.
Cervical cancer (awaiting treatment)
There is concern about the increased risk of infection and bleeding at insertion. The IUD will likely need to be removed at the time of treatment but, until then, the woman is at risk of pregnancy.
Breast disease
Breast cancer: breast cancer is a hormonally sensitive tumour. Concerns about progression of the disease may be less with lng-iuds than with combined oral contraceptives (cocs) or higher-dose progestogen-only contraceptives (POCs).
Endometrial cancer
There is concern about the increased risk of infection, perforation and bleeding at insertion. The iud will likely need to be removed at the time of treatment but, until then, the woman is at risk of pregnancy.
Ovarian cancer
The IUD will likely need to be removed at the time of treatment but, until then, the woman is at risk of pregnancy.
Uterine fibroids
Without distortion of the uterine cavity: Women with heavy or prolonged bleeding should be assigned the category for that condition.
With distortion of the uterine cavity: Pre-existing uterine fibroids that distort the uterine cavity may be incompatible with insertion and proper placement of the IUD.
Anatomical abnormalities
Distorted uterine cavity: In the presence of an anatomic abnormality that distorts the uterine cavity, proper IUD placement may not be possible.
Pelvic inflammatory disease (PID)
IUDs do not protect against STI/HIV/PID. In women at low risk of STIs, IUD insertion poses little risk of PID. Current risk of STIs and desire for future pregnancy are relevant considerations.
Tuberculosis
Pelvic: Insertion of an IUD may substantially worsen the condition.
History of cholestasis
There is concern that a history of cholestasis related to combined hormonal contraceptives (CHCs) may predict subsequent cholestasis with LNG use. Whether there is any risk with use of an LNG-IUD is unclear.
Liver tumours
There is no evidence regarding hormonal contraceptive use among women with hepatocellular adenoma. Given that COC use in healthy women is associated with development and growth of hepatocellular adenoma, it is not known whether other hormonal contraceptives have similar effects.
Thalassaemia, sickle cell disease, iron-deficiency anaemia
There is concern about a risk of increased blood loss with Cu-IUDs.
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2.7.5. Copper-bearing IUD for emergency contraception (E-IUD)
Use of a copper-bearing IUD (Cu-IUD) for emergency contraception (E-IUD) is highly effective for preventing pregnancy. For this purpose, a Cu-IUD can be inserted within five days of unprotected intercourse. However, when the time of ovulation can be estimated, the Cu-IUD can be inserted beyond five days after intercourse, if necessary, as long as the insertion does not occur more than five days after ovulation.
The eligibility criteria for general Cu-IUD insertion also apply for the insertion of E-IUDs (see section 2.7.4 on IUDs, pp. 175–188).
ADDITIONAL COMMENTS
Rape
IUDs do not protect against STI/HIV or pelvic inflammatory disease (PID). Among women with chlamydial infection or gonorrhoea, the potential increased risk of PID with IUD insertion should be avoided. The concern is less for other STIs.
2.7.6. Progesterone-releasing vaginal ring (PVR) for breastfeeding women
The progesterone-releasing vaginal ring (PVR) is a contraceptive method for women who are actively breastfeeding at least four times a day. It consists of a flexible ring that releases 10 µg/day of progesterone. During use, average plasma concentrations of 20 nmol/L are achieved, which are similar to those detected in the average luteal phase in normal fertile women. The PVR is worn continuously for three-month periods (approximately 90 days) and can be initiated at six weeks after childbirth. Use of the PVR during breastfeeding requires replacing the used ring with a new ring at three-month intervals (± two weeks). The mechanism of contraceptive action of the PVR is through the inhibition of ovulation (1, 2).
RECOMMENDATIONS REVIEWED FOR FIFTH EDITION
These recommendations were reviewed according to WHO requirements for guideline development, as part of the preparation of the Medical eligibility criteria for contraceptive use, fifth edition. The population, intervention, comparator, outcome (PICO) questions developed by the Guideline Development Group (GDG) and the databases searched to retrieve the evidence, which guided the preparation of systematic reviews, are described in greater detail in Part I of this document. Additionally, GRADE evidence profiles, the overall GRADE assessment of the quality of the evidence, summaries of the evidence supporting the recommendation(s), and other supplementary remarks from the GDG regarding the recommendations, are available in Part I.
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- Chen JH, Wu SC, Shao WQ, Zou MH, Hu J, Cong L, et al. The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women. Contraception. 1998;57(6):371–9. [PubMed: 9693396]
2.7.7. Barrier methods (BARR)
ADDITIONAL COMMENTS
Obesity
Severe obesity may make diaphragm and cap placement difficult.
Valvular heart disease
Risk of urinary tract infection with the diaphragm may increase in a client with subacute bacterial endocarditis.
Cervical cancer (awaiting treatment)
Repeated and high-dose use of nonoxynol-9 can cause vaginal and cervical irritation or abrasions.
High risk of HIV
Category 4 for diaphragm use is assigned due to concerns about the spermicide, not the diaphragm.
Asymptomatic or mild HIV clinical disease (WHO stage 1 or 2)
Use of spermicides and/or diaphragms (with spermicide) can disrupt the cervical mucosa, which may lead to increased viral shedding and HIV transmission to uninfected sexual partners.
Severe or advanced hiv clinical disease (WHO stage 3 or 4)
Use of spermicides and/or diaphragms (with spermicide) can disrupt the cervical mucosa, which may lead to increased viral shedding and HIV transmission to uninfected sexual partners.
History of toxic shock syndrome
Toxic shock syndrome has been reported in association with diaphragm use.
Urinary tract infection
There is a potential increased risk of urinary tract infection with diaphragms and spermicides.
References
- 1.
- Wilkinson D, Ramjee G, Tholandi M, Rutherford G. Nonoxynol-9 for preventing vaginal acquisition of HIV infection by women from men. Cochrane Database Syst Rev. 2002;4 (CD003936) [PMC free article: PMC8407148] [PubMed: 12519622]
2.7.8. Fertility awareness-based (FAB) methods
Fertility awareness-based (FAB) methods of family planning involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature (i.e. symptoms-based methods) or by monitoring cycle days (calendar-based methods).
Symptom-based methods
Symptoms-based methods include the cervical mucus method (also called the ovulation method) and the TwoDay Method, which are both based on the evaluation of cervical mucus, and the sympto-thermal method, which is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day.
Calendar-based methods
Calendar-based methods include the Calendar Rhythm Method and the Standard Days Method, which avoids intercourse on cycle days 8–19.
FAB methods can be used in combination with abstinence or barrier methods during the fertile time. If barrier methods are used, refer to section 2.7.7 on barrier methods (BARR), see pp. 200–211.
There are no medical conditions that become worse because of use of FAB methods. In general, these methods can be provided without concern for health effects to people who choose them; therefore, the 1–4 recommendation categories do not apply to these methods. However, there are a number of conditions that make their use more complex. The existence of these conditions suggests that (i) use of FAB methods should be delayed until the condition is corrected or resolved, or (ii) use of FAB methods will require special counselling for the client, and a more highly trained provider is generally necessary to ensure correct use. The need for caution or delay in the use of these FAB methods is noted in the categories assigned in the table, per condition.
ADDITIONAL COMMENTS
Breastfeeding
Fertility awareness-based (FAB) methods during breastfeeding may be less effective than when not breastfeeding.
< 6 weeks postpartum: Women who are exclusively breastfeeding and are amenorrhoeic are unlikely to have sufficient ovarian function to produce detectable fertility signs and hormonal changes during the first six weeks postpartum. However, the likelihood of resumption of fertility increases with time postpartum and with substitution of breast-milk by other foods.
After menses begin: When the woman notices fertility signs (particularly cervical secretions), she can use a symptoms-based method. First postpartum menstrual cycles in breastfeeding women vary significantly in length. It takes several cycles for the return to regularity. When she has had at least three postpartum menses and her cycles are regular again, she can use the Calendar Rhythm Method. When she has had at least four postpartum menses and her most recent cycle was 26–32 days long, she can use the Standard Days Method. Prior to that time, a barrier method should be offered if the woman plans to use a FAB method later.
Postpartum
< 4 weeks: Non-breastfeeding woman are not likely to have sufficient ovarian function to either require a FAB method or have detectable fertility signs or hormonal changes prior to four weeks postpartum. Although the risk of pregnancy is low, a method that is appropriate for the postpartum period should be offered.
≥ 4 weeks: Non-breastfeeding women are likely to have sufficient ovarian function to produce detectable fertility signs and/or hormonal changes at this time; the likelihood increases rapidly with time postpartum. A woman can use calendar-based methods as soon as she has completed at least three postpartum menses and her cycles are regular again. A woman can use the Standard Days Method when she has had at least four postpartum menses and her most recent cycle was 26–32 days long. Methods appropriate for the postpartum period should be offered prior to that time.
Post-abortion
Post-abortion women are likely to have sufficient ovarian function to produce detectable fertility signs and/or hormonal changes; the likelihood increases with time post-abortion. A woman can start using calendar-based methods after she has had at least one post-abortion menses; if most of her cycles prior to this pregnancy were 26–32 days long, she can use the Standard Days Method. Methods appropriate for the post-abortion period should be offered prior to that time.
2.7.9. Lactational amenorrhoea method (LAM)
The Bellagio Consensus provided the scientific basis for defining the conditions under which breastfeeding can be used safely and effectively for birth-spacing purposes, and programmatic guidelines were developed for the use of the LAM in family planning. These guidelines include the following three criteria, all of which must be met to ensure adequate protection from an unplanned pregnancy:
- amenorrhoea
- fully or nearly fully breastfeeding
- less than six months postpartum.
The main indications for breastfeeding remain the need to provide an ideal food for the infant and to protect it against disease. There are no medical conditions in which the use of the LAM is restricted and there is no documented evidence of its negative impact on maternal health. However, certain conditions or obstacles which affect breastfeeding may also affect the duration of amenorrhoea, making this a less useful choice for family planning purposes. These include:
HIV
Breastfeeding should be promoted, protected and supported in all populations, for all women who are HIV-negative or of unknown HIV status. A woman living with HIV, however, can transmit the virus to her child through breastfeeding. Yet breastfeeding, and especially early and exclusive breastfeeding, is one of the most critical factors for improving child survival. Breastfeeding also confers many other benefits in addition to reducing the risk of death.
There is now strong evidence that giving antiretroviral medications (ARVs) to either the HIV-positive mother or the HIV-exposed infant or both can significantly reduce the risk of transmitting HIV through breastfeeding.15 This transforms the landscape in which decisions should be made by national health authorities and individual mothers. In the presence of ARVs – either lifelong antiretroviral therapy (ART) to the mother or other ARV interventions to the mother or infant – the infant can receive all the benefits of breastfeeding with little risk of acquiring HIV. In some well-resourced countries with low infant and child mortality rates, avoidance of all breastfeeding will still be appropriate.
Mothers living with HIV should receive the appropriate ARV interventions and should exclusively breastfeed their infants for the first six months of life, introducing appropriate complementary foods thereafter, and should continue breastfeeding their infants for the first 12 months of life. Breastfeeding should then only stop once a nutritionally adequate and safe diet without breast-milk can be provided. When mothers decide to stop breastfeeding, they should stop gradually within one month and infants should be provided with safe and adequate replacement feeds to enable normal growth and development.
If the infant is HIV-negative or of unknown HIV status
A mother known to be living with HIV should only give commercial infant formula milk as a replacement feed to this infant when all of the following specific conditions are met:
- safe water and sanitation are assured at the household level and in the community, and
- the mother or other caregiver can reliably provide sufficient infant formula milk to support normal growth and development of the infant, and
- the mother or caregiver can prepare it cleanly and frequently enough so that it is safe and carries a low risk of diarrhoea and malnutrition, and
- the mother or caregiver can, in the first six months, exclusively give infant formula milk, and
- the family is supportive of this practice, and
- the mother or caregiver can access health care that offers comprehensive child health services.
If the infant is known to be HIV-positive
The mother is strongly encouraged to exclusively breastfeed for the first six months of the infant's life and to continue breastfeeding as per the recommendations for the general population, that is up to two years or beyond.
Women who are living with HIV should receive skilled counselling to help them. They should also have access to follow-up care and support, including family planning and nutritional support.
Medication used during breastfeeding
In order to protect infant health, breastfeeding is not recommended for women using such drugs as: anti-metabolites, bromocriptine, certain anticoagulants, corticosteroids (high doses), ciclosporin, ergotamine, lithium, mood-altering drugs, radioactive drugs and reserpine.
Conditions affecting the newborn
Congenital deformities of the mouth, jaw or palate; newborns who are small-for-date or premature and needing intensive neonatal care; and certain metabolic disorders of the infant can all make breastfeeding difficult.
2.7.10. Coitus interruptus (CI)
Coitus interruptus (CI), also known as withdrawal, is a traditional family planning method in which the man completely removes his penis from the vagina, and away from the external genitalia of the female partner, before he ejaculates. CI prevents sperm from entering the woman's vagina, thereby preventing contact between spermatozoa and the ovum.
This method may be appropriate for couples:
- who are highly motivated and able to use this method effectively;
- with religious or philosophical reasons for not using other methods of contraception;
- who need contraception immediately and have entered into a sexual act without alternative methods available;
- who need a temporary method while awaiting the start of another method;
- who have intercourse infrequently.
Some benefits of CI are that the method, if used correctly, does not affect breastfeeding and is always available for primary use or use as a back-up method. In addition, CI involves no economic cost or use of chemicals. There are no health risks associated directly with CI.
Men and women who are at high risk of STI/HIV infection should use a condom with each act of intercourse.
CI is unforgiving of incorrect use, and its effectiveness depends on the willingness and ability of the couple to use withdrawal with every act of intercourse.
2.7.11. Surgical sterilization procedures (STER)
Given that sterilization is a surgical procedure that is intended to be permanent, special care must be taken to assure that every client makes a voluntary, informed choice of the method. Particular attention must be given in the case of young people, nulliparous women, men who have not yet been fathers and clients with mental health problems, including depressive conditions. All clients should be carefully counselled about the intended permanence of sterilization and the availability of alternative, long-term, highly effective methods. This is of extra concern for young people. The national laws and existing norms for the delivery of sterilization procedures must be considered in the decision process.
Transcervical methods of female sterilization are not addressed in these recommendations.
There is no medical condition that would absolutely restrict a person's eligibility for sterilization, although some conditions and circumstances will require that certain precautions are taken, including those where the recommendation is assigned as Category C (caution), D (delay) or S (special). For some of these conditions and circumstances, the theoretical or proven risks may outweigh the advantages of undergoing sterilization, particularly female sterilization. Where the risks of sterilization outweigh the benefits, long-term, highly effective contraceptive methods are a preferable alternative. Decisions in this regard will have to be made on an individual basis, considering the risks and benefits of sterilization versus the risks of pregnancy, and the availability and acceptability of highly effective, alternative methods.
Sterilization procedures should only be performed by well-trained providers in appropriate clinical settings using proper equipment and supplies. Appropriate service-delivery guidelines, including infection-prevention protocols, should be followed to maximize client safety.
ADDITIONAL COMMENTS FOR FEMALE STERILIZATION
Parity
Nulliparous women: Like all women, they should be counselled about the permanency of sterilization and the availability of alternative, long-term, highly effective methods.
Postpartum
- < 7 days postpartum: Sterilization can be safely performed immediately postpartum.
- 7 to < 42 days: There is an increased risk of complications when the uterus has not fully involuted.
- Pre-eclampsia/eclampsia: There are increased anaesthesia-related risks.
- Prolonged rupture of membranes, 24 hours or more: There is an increased risk of postoperative infection.
- Puerperal sepsis, intrapartum or puerperal fever: There is an increased risk of postoperative infection.
- Severe antepartum or postpartum haemorrhage: The woman may be anaemic and unable to tolerate further blood loss.
- Severe trauma to the genital tract (cervical or vaginal tear at the time of delivery): There may have been significant blood loss and anaemia.
- Uterine rupture or perforation: There may have been significant blood loss or damage to abdominal contents.
Post-abortion
- Post-abortal sepsis or fever: There is an increased risk of postoperative infection.
- Severe post-abortal haemorrhage: The woman may be anaemic and unable to tolerate further blood loss.
- Severe trauma to the genital tract (cervical or vaginal tear at the time of abortion): The woman may be anaemic and unable to tolerate further blood loss. The procedure may be more painful.
- Uterine perforation: There may have been significant blood loss or damage to abdominal contents.
- Acute haematometra: The woman may be anaemic and unable to tolerate further blood loss.
OTHER CONSIDERATIONS
Multiple risk factors for arterial cardiovascular disease
Concurrent presence of multiple risk factors: There may be a high risk of complications associated with anaesthesia and surgery.
Current and history of ischaemic heart disease
There is a high risk of complications associated with anaesthesia and surgery.
Cervical cancer (awaiting treatment), endometrial cancer, ovarian cancer
In general, the treatment renders a woman sterile.
Uterine fibroids
Depending on the size and location of the fibroids, it might be difficult to localize the tubes and mobilize the uterus.
Pelvic inflammatory disease (pid)
PID can lead to an increased risk of post-sterilization infection or adhesions.
STIs
There is an increased risk of postoperative infection.
Diabetes
There is a risk of hypoglycaemia or ketoacidosis when the procedure is performed, particularly if blood sugar is not well controlled before the procedure.
Thyroid disorders
There is a higher risk of complications associated with anaesthesia and surgery.
Viral hepatitis
There is a high risk for complications associated with anaesthesia and surgery.
Sickle cell disease
There is an increased risk of pulmonary, cardiac or neurologic complications and possible increased risk of wound infection.
Coagulation disorders
There is a higher risk of haematologic complications of surgery.
Systemic infection or gastroenteritis
There are increased risks of postoperative infection, complications from dehydration, and anaesthesia-related complications.
Fixed uterus due to previous surgery or infection
Decreased mobility of the uterus, fallopian tubes and bowel may make laparoscopy and minilaparotomy difficult and increase the risk of complications.
Diaphragmatic hernia
For laparoscopy, a woman may experience acute cardiorespiratory complications induced by pneumoperitoneum or the Trendelenburg position.
Kidney disease
Blood clotting may be impaired. There may be an increased risk of infection and hypovolemic shock. Condition may cause baseline anaemia, electrolyte disturbances, and abnormalities in drug metabolism and excretion.
Severe nutritional deficiencies
There may be an increased risk of wound infection and impaired healing.
Sterilization concurrent with caesarean section
There is no increased risk of complications in a surgically stable client.
ADDITIONAL COMMENTS FOR MALE STERILIZATION
Diabetes
Individuals with diabetes are more likely to get postoperative wound infections. If signs of infection appear, treatment with antibiotics needs to be given.
Local infection
There is an increased risk of postoperative infection.
Coagulation disorders
Bleeding disorders lead to an increased risk of postoperative haematoma formation, which, in turn, leads to an increased risk of infection.
Systemic infection or gastroenteritis
There is an increased risk of postoperative infection.
Large varicocele
The vas may be difficult or impossible to locate; a single procedure to repair varicocele and perform a vasectomy decreases the risk of complications.
Large hydrocele
The vas may be difficult or impossible to locate; a single procedure to repair hydrocele and perform a vasectomy decreases the risk of complications.
Filariasis; elephantiasis
If elephantiasis involves the scrotum, it may be impossible to palpate the spermatic cord and testis.
Intrascrotal mass
This may indicate underlying disease.
Inguinal hernia
Vasectomy can be performed concurrent with hernia repair.
Sickle cell disease
There is an increased risk of pulmonary, cardiac or neurologic complications and possible increased risk of wound infection.
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2.7.12. Summary table (SUMM)
This summary table highlights the medical eligibility recommendations for combined hormonal contraceptives (COC, CIC, patch [P] and vaginal ring [CVR]), progestogen-only contraceptives (POP, DMPA/NET-EN injectables, and LNG/ETG implants) and intrauterine devices (Cu-IUD and LNG-IUD). For further information about these recommendations, please consult the corresponding method tables. Eligibility recommendations for emergency contraceptive pills (ECPs), IUDs for emergency contraception (E-IUD), progesterone-releasing vaginal rings (PVR), barrier methods (BARR), fertility awareness-based (FAB) methods, lactational amenorrhea method (LAM), coitus interruptus (CI) and surgical sterilization (STER) are presented in their respective sub-sections in this document.
Footnotes
- 1
Report of the International Conference on Population and Development (Cairo, 5–13 September 1994). United Nations: 1994. [24 April 2015]. Programme of Action of the International Conference on Population and Development. para. 7.2 (A/CONF.171/13, http://www
.un.org/popin /icpd/conference/offeng/poa.html.. - 2
Report of the Fourth World Conference on Women (Beijing, 4–15 September, 1995). United Nations: 1995. [17 April 2015]. Beijing Declaration and Platform for Action. para. 95 (A/CONF.177/20; http://www
.un.org/documents /ga/conf177/aconf177–20en.htm.. - 3
Ensuring human rights in the provision of contraceptive information and services: guidance and recommendations. Geneva: World Health Organization; 2014. [24 April 2015]. http://apps
.who.int/iris /bitstream/10665 /102539/1/9789241506748_eng.pdf. [PubMed: 24696891]. - 4
Koenig MA. The impact of quality of care on contraceptive use: evidence from longitudinal data from rural Bangladesh. Baltimore (MD): Johns Hopkins University; 2003. .
- 5
Arends-Kuenning M, Kessy FL. The impact of demand factors, quality of care and access to facilities on contraceptive use in Tanzania. J Biosoc Sci. 2007;39:1–26. [PubMed: 16359581].
- 6
RamaRao S, Lacuest M, Costello M, Pangolibay B, Jones H. The link between quality of care and contraceptive use. Int Fam Plann Perspect. 2003;29(2):76–83 [PubMed: 12783771].
- 7
Sanogo D, RamaRao S, Johnes H, N'diaye P, M'bow B, Diop CB. Improving quality of care and use of contraceptives in Senegal. Afr J Reprod Health. 2003;7:57–73. [PubMed: 14677301].
- 8
This can be context specific. These may include high prevalence rates of STIs and HIV in the geographic area, and/or individual risk behaviour such as multiple partners without using condoms.
- 9
Resolution adopted by the United Nations General Assembly. United Nations: 2006. [24 April 2015]. United Nations Convention on the Rights of Persons with Disabilities. A/RES/61/106; http://www
.un-documents.net/a61r106.htm.. - 10
World report on disability 2011. Geneva: World Health Organization; 2011. [9 April 2015]. http://www
.who.int/disabilities /world_report/2011/report/en/ [PubMed: 26131540]. - 11
Ibid.
- 12
Available at: http:
//ihs-classification .org/en/02_klassifikation - 13
Available at: http:
//ihs-classification .org/en/02_klassifikation - 14
Available at: http:
//ihs-classification .org/en/02_klassifikation - 15
Further information: http://www
.who.int/hiv/topics/mtct
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Publisher
World Health Organization, Geneva
NLM Citation
Medical Eligibility Criteria for Contraceptive Use. 5th edition. Geneva: World Health Organization; 2015. II, Using the recommendations.