Many women in the reproductive years have chronic medical conditions that are affected by pregnancy or in which the fetus is placed at increased risk. In most of these women, ongoing medical management of their conditions is greatly improved, even compared with a decade or two ago. However, their condition may still be seriously exacerbated by the physiological changes of pregnancy, and close monitoring of a carefully planned pregnancy is optimal. This requires effective and safe contraceptive use until pregnancy is desired and the medical condition is stabilised. Many contraceptives will also have adverse effects on some medical conditions, and there is now a considerable awareness of the complexities of some of these interactions. For this reason the World Health Organization has developed an excellent, simple and pragmatic programme of guidelines on a four point scale (the WHO “Medical Eligibility Criteria”: WHO-MEC), summarising risk of specific contraceptive methods in women with specified chronic medical conditions. The general approach to contraceptive management of many of these conditions is addressed in this article.
Introduction
Throughout most of the world, access to effective contraception is accepted as one of women’s basic rights. This may be of high social importance and lifestyle planning for the majority of women and couples, but for some women with specific medical disorders the careful planning of a pregnancy may be critical to future health and even risk of pregnancy-related death . Effective contraception allows for a small number of pregnancies, which the woman of the future is expected to have, to be planned in such a way that she enters pregnancy in a suitable state of health and wellbeing so that outcomes can be optimal for mother and infant. This also presupposes that she should have access to the required level of healthcare. This particular requirement may be of crucial importance and a significant challenge for the woman with certain pre-existing medical disorders.
Pregnancy is a state which makes substantial demands on the health and physical resources of the mother . Hence, ideally all pregnancies should be well planned in advance, and again ideally, all women should have their potential risk factors assessed in advance of embarking on a pregnancy. This ideal situation is beginning to be achieved at pre-pregnancy clinics for some women with recognised risk factors in countries with advanced healthcare systems, but there is still a long way to go. The use of effective and safe contraception facilitates the establishment of such clinics.
Key principles for attention are the impact of the maternal medical condition on the outcome of pregnancy – for both mother and fetus – and the impact of pregnancy on the maternal disease. In addition, the clinician must assess the positive and negative attributes of each effective method of contraception against the specific background of the state of the medical condition suffered by the woman. This risk assessment for each contraceptive method has been greatly facilitated in recent years by the efforts of the World Health Organization in developing very detailed guidelines for contraception in specific maternal diseases through the Medical Eligibility Criteria (WHO-MEC) programme . Several countries, such as the United Kingdom (UK-MEC) and the United States of America have developed modifications of the original WHO versions taking into account national health management systems, local health programmes and available resources. These national programmes are, however, all based on principles developed through the different versions of the WHO-MEC programme.
There are many serious medical conditions which can be well managed in pregnancy nowadays, with appropriate planning, whereas only a decade or so ago many of these conditions carried a relatively strong contraindication to pregnancy. Planning for the management of such pregnancies is now dependent on the availability of appropriate medical facilities in a centre to which the woman has access. Relative contraindications to pregnancy still exist for many women with pre-existing medical conditions that need to be balanced against any relative contraindications to use of specific methods of contraception. Issues needing to be directly addressed include the need for highly effective contraceptive protection balanced against possible short or long-term hazards of use of the specific contraceptive. These hazards vary considerably from one patient to another depending on the individual severity of the condition and the contraceptive methods being considered. A list of the more important groups of medical conditions where MEC assessment should be carried out will be illustrated in the review ( Table 1 ).
| 1 | Women with cardiac diseases |
| 1 | Women with hypertension |
| 2 | Women with diabetes, obesity or metabolic syndrome |
| 3 | Women at risk of venous thromboembolism |
| 4 | Women with migrainous headache |
| 5 | Women with epilepsy |
| 6 | Women with systemic lupus erythematosus and other autoimmune conditions |
| 7 | Women with HIV/AIDS |
| 8 | With other varied conditions |
Issues needing to be balanced in the assessment of each individual woman can be best encapsulated by addressing the following considerations:
- 1.
The risks associated with pregnancy in this woman
- 2.
The effect of specific contraceptive methods on this disease
- 3.
Contraceptive failure rates for those methods potentially suitable for this woman
- 4.
Potential interactions of drugs used for the medical condition with potentially suitable contraceptive methods
- 5.
Consequences of an unplanned pregnancy (“back-up plan for contraceptive failure”)
- 6.
Preferences of the individual woman
- 7.
Preconception counselling to address these issues and formulate choices
–What specialist care may be required to offer optimal management of her contraception, or a subsequent pregnancy, in the light of available resources?
The World Health Organization Medical Eligibility Criteria
The concept was built on four cornerstones of a wider perspective of reproductive and sexual health care, including “who” can use contraceptive methods safely, guidance on “how” to use contraceptives safely and effectively, a “decision-making tool” for family planning and a “Family Planning Handbook” with practical tools for improved counselling and delivery of service. These documents are aimed at policy makers, family planning programme managers and the clinical and scientific communities. Countries and their environmental and cultural standing vary greatly, so the recommendations are merely a guide to various contraceptive methods available, and the most up-to-date measures in the light of various health conditions. For this reason, the WHO-MEC does not set firm international guidelines and criteria for contraceptive use. Rather, it aims to provide guidance and reference to national family planning/reproductive health programmes in light of their own national health policies, needs, priorities and resources.
The Medical Eligibility Criteria – WHO-MEC – have been developed in a series of meetings of experts in WHO Headquarters in Geneva over the last couple of decades, the most recent major review being in 2009 . These meetings involve a large number of recognised international experts representing many countries and all major cultural groups, and are focused upon a very detailed review of the medical literature, with recommendations being made for all methods of contraception for all pre-existing medical conditions. These recommendations are based primarily on evidence derived from sound clinical trials, supplemented by best available expert clinical opinion. However, for many reasons, sound evidence for use of specific contraceptive methods in particular uncommon or rare medical conditions is often limited or lacking . In these situations, expert opinion is focused on extrapolation from evidence gained in women with other conditions or without any contraindications. Many of the original large gaps in this literature are now being addressed by specific studies, which provide a much stronger basis for reassurance that the advice being provided about less common diseases is sound.
WHO has developed a system where recommendations for each type of contraceptive for each medical condition have been placed in one of four categories ( Table 2 ). WHO-MEC can be accessed through the World Health Organization (Geneva Headquarters) website , and all physicians responsible for the care of women in the reproductive phase of life should be aware of this guidance and the means of rapidly consulting it.
| Contraception for specific medical conditions: | |
| Category 1 | No restriction for the use of this contraceptive method in this condition |
| Category 2 | Advantages of using this method generally outweigh the theoretical or proven risks |
| Category 3 | Theoretical or proven risks in this condition generally outweigh the advantages of using this method |
| Category 4 | Use of this contraceptive method in this condition represents an unacceptable health risk |
| Sterilisation for specific medical conditions: | |
| Category A | No medical reason to deny sterilisation to a woman with this condition |
| Category C | The sterilisation procedure is carried out in a routine clinical setting, but with extra preparation, precautions and counselling. |
| Category D | The procedure is delayed until the condition is further evaluated, treated or changes. Alternative temporary methods of contraception should be provided. |
| Category S | The procedure should be undertaken in a setting with an experienced surgeon and staff, equipment to provide general anaesthesia and other back-up medical support. Capacity to decide on the most appropriate procedure and anaesthesia method is needed. Alternative temporary methods of contraception should be provided if referral is required or there is otherwise delay. |
Particular attention may be needed for counselling of women who are considering a permanent approach to contraception – sterilisation – and the UK-MEC includes sound categories shaped along similar lines (4 categories) as for reversible contraception ( Table 2 ).
These recommendations should assist specialised family planners, general practitioners and non-medical health practitioners to offer sound advice to women with a wide range of pre-existing medical conditions.
Major categories of contraception and relevant key factors
- 1.
Hormonal contraception methods:
- a)
Combined oestrogen-progestogen methods (include orals, vaginal rings, transdermal patches). In most of these methods the oestrogen component is ethinyl oestradiol. These methods are highly effective contraceptives if used carefully and according to instructions. However, they do carry a small absolute increase in risk of venous thromboembolism (VTE). The extent of this very small risk is still controversial, especially when considering whether the risk is really raised to a greater extent with specific combinations. It is thought that the inclusion of ethinyl oestradiol is the culprit in raising risk, but it is not known whether this risk is lower with the new oestradiol-17β-based orals. These combined oestrogen-progestogen methods should be avoided in women with an inherent VTE risk due to their condition. There are also compliance issues with each of these methods. These are all methods under the direct control of the woman herself, and some women are less good at remembering to take a daily pill, or change a patch at the right time. These methods have excellent contraceptive efficacy if taken meticulously. They are convenient, well-studied and easy to start and stop, if they are deemed compatible with the woman’s medical condition by a knowledgeable health professional.
- b)
Progestogen-only methods are currently gaining rapidly increasing usage in many countries worldwide, although their popularity overall is still low. They can be administered orally, by intra-muscular or sub-cutaneous injection, by subdermal implant or by intrauterine system. Progestogen-only minipills (POPs) with very low dose norethisterone or levonorgestrel have been available for more than 5 decades, and are reasonably effective methods if taken meticulously. It should be recognised that norethisterone is partially converted into ethinyl oestradiol in the body, but this is not a practical problem with minipills, but may be so with therapeutic norethisterone or the injectable, norethisterone enanthate . In many countries these original minipills are now being superseded by newer oral progestogens, such as desogestrel 75μg daily, which has a probably higher level of contraceptive efficacy than older POPs, especially in women who are not breast-feeding, and also a higher rate of amenorrhoea. These still require careful attention to regular daily administration.
One of the big advantages of progestogen-only methods is that they can be administered by routes which allow the convenience of prolonged duration of action, especially by subdermal implant (with levonorgestrel or etonogestrel) or by intrauterine delivery system (with levonorgestrel). These are very highly effective contraceptives, and they have the major advantage that they do not carry the slightly increased risk of VTE that is seen with oestrogen-containing hormonal methods. This means that they may have great benefit in some of the women with pre-existing medical conditions where VTE risk is raised.
- a)
- 2.
Intrauterine
- a)
Modern Copper-bearing IUDs are highly cost-effective contraceptives, with registration approval for up to 10 years of continuous contraceptive use. These contain no hormones and do not influence the risk of venous thromboembolism. They do not alter the menstrual pattern, but they tend to increase the heaviness of menstrual bleeding, sometimes substantially. Hence they are not a good choice in women with conditions leading to iron deficiency and anaemia.
- b)
The levonorgestrel-releasing intrauterine system (LNG-IUS) is one of the most valuable of modern contraceptive systems for women with pre-existing medical disorders due to its local release of LNG (20 micrograms daily) within the uterine cavity, where it has a very high contraceptive effect. Only small amounts of LNG reach the general circulation, and general and metabolic effects are small. The main side-effects are reduced, but irregular, menstrual bleeding and amenorrhoea. This system and the subdermal etonogestrel implant are the two most effective reversible contraceptive methods, in spite of releasing relatively low, but constant, amounts of progestogen into the body. These methods can be used with relative safety in the great majority of women with medical conditions.
- a)
- 3.
Other: Condoms and sterilisation are potentially suitable methods for almost all conditions, but lower contraceptive efficacy with condoms must be borne in mind.
Major categories of contraception and relevant key factors
- 1.
Hormonal contraception methods:
- a)
Combined oestrogen-progestogen methods (include orals, vaginal rings, transdermal patches). In most of these methods the oestrogen component is ethinyl oestradiol. These methods are highly effective contraceptives if used carefully and according to instructions. However, they do carry a small absolute increase in risk of venous thromboembolism (VTE). The extent of this very small risk is still controversial, especially when considering whether the risk is really raised to a greater extent with specific combinations. It is thought that the inclusion of ethinyl oestradiol is the culprit in raising risk, but it is not known whether this risk is lower with the new oestradiol-17β-based orals. These combined oestrogen-progestogen methods should be avoided in women with an inherent VTE risk due to their condition. There are also compliance issues with each of these methods. These are all methods under the direct control of the woman herself, and some women are less good at remembering to take a daily pill, or change a patch at the right time. These methods have excellent contraceptive efficacy if taken meticulously. They are convenient, well-studied and easy to start and stop, if they are deemed compatible with the woman’s medical condition by a knowledgeable health professional.
- b)
Progestogen-only methods are currently gaining rapidly increasing usage in many countries worldwide, although their popularity overall is still low. They can be administered orally, by intra-muscular or sub-cutaneous injection, by subdermal implant or by intrauterine system. Progestogen-only minipills (POPs) with very low dose norethisterone or levonorgestrel have been available for more than 5 decades, and are reasonably effective methods if taken meticulously. It should be recognised that norethisterone is partially converted into ethinyl oestradiol in the body, but this is not a practical problem with minipills, but may be so with therapeutic norethisterone or the injectable, norethisterone enanthate . In many countries these original minipills are now being superseded by newer oral progestogens, such as desogestrel 75μg daily, which has a probably higher level of contraceptive efficacy than older POPs, especially in women who are not breast-feeding, and also a higher rate of amenorrhoea. These still require careful attention to regular daily administration.
One of the big advantages of progestogen-only methods is that they can be administered by routes which allow the convenience of prolonged duration of action, especially by subdermal implant (with levonorgestrel or etonogestrel) or by intrauterine delivery system (with levonorgestrel). These are very highly effective contraceptives, and they have the major advantage that they do not carry the slightly increased risk of VTE that is seen with oestrogen-containing hormonal methods. This means that they may have great benefit in some of the women with pre-existing medical conditions where VTE risk is raised.
- a)
- 2.
Intrauterine
- a)
Modern Copper-bearing IUDs are highly cost-effective contraceptives, with registration approval for up to 10 years of continuous contraceptive use. These contain no hormones and do not influence the risk of venous thromboembolism. They do not alter the menstrual pattern, but they tend to increase the heaviness of menstrual bleeding, sometimes substantially. Hence they are not a good choice in women with conditions leading to iron deficiency and anaemia.
- b)
The levonorgestrel-releasing intrauterine system (LNG-IUS) is one of the most valuable of modern contraceptive systems for women with pre-existing medical disorders due to its local release of LNG (20 micrograms daily) within the uterine cavity, where it has a very high contraceptive effect. Only small amounts of LNG reach the general circulation, and general and metabolic effects are small. The main side-effects are reduced, but irregular, menstrual bleeding and amenorrhoea. This system and the subdermal etonogestrel implant are the two most effective reversible contraceptive methods, in spite of releasing relatively low, but constant, amounts of progestogen into the body. These methods can be used with relative safety in the great majority of women with medical conditions.
- a)
- 3.
Other: Condoms and sterilisation are potentially suitable methods for almost all conditions, but lower contraceptive efficacy with condoms must be borne in mind.
A general approach to contraceptive management of women with medical disorders
In situations where a health professional is unfamiliar with the contraceptive risks and requirements of women with specific underlying medical conditions, it is recommended that the following matters be taken into consideration:
- (a)
assess the patient and her level of disease severity;
- (b)
determine the risks of pregnancy in a woman with her severity and individual characteristics of disease;
- (c)
define her contraceptive needs, including expected duration of need;
- (d)
then consult the relevant WHO or local MEC tables;
- (e)
consider specialist review of contraceptive effect to determine the likelihood of other outcomes in someone with her particular combination of disease characteristics;
- (f)
counsel the patient and partner about the likely and possible outcomes of pregnancy under optimal circumstances, the possible effects of contraceptive choices and the possible persisting risks;
- (g)
the patient should determine the choice of contraceptive method after counselling.
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