How much Supervision is Necessary for Women Taking Mifepristone and Misoprostol for Early Medical Abortion?

The promise of [early pregnancy termination with mifepristone and misoprostol] is often compromised by overly medicalized practices and regulations … that are barriers to greater acceptability, access and availability.'

The advent of early pregnancy termination with mifepristone and misoprostol promised the availability of safe abortion services regardless of legal restrictions or women's access to healthcare resources. Since the introduction of mifepristone in France and China nearly two decades ago, medical abortion increasingly has been incorporated into clinical practice, and in some jurisdictions has become the standard of care. However, the promise of the method is often compromised by overly medicalized practices and regulations – sometimes encoded in laws and high-level healthcare policies – that are barriers to greater acceptability, access and availability.

Mifepristone registration is currently limited to approximately 40 countries – primarily in North America, Europe and Asia – where abortion is legal and available with few restrictions. Yet even where the drugs are available, uptake has not yet reached levels consistent with women's demand [1,2]. Low uptake reflects the fact that provision of early medical abortion remains limited in terms of who can provide it (generally only physicians, who frequently must also hand the medication over to the women), and where/how it can be provided (in clinics under relatively strict medical supervision). Consequently, in places where the need is most acute, for example, where either abortion providers are few or services are unsafe, limited or inaccessible, medical abortion remains something only to be read about in textbooks or heard about at conferences.

Expanding medical abortion provision to help meet this need depends largely on widening the definition of who can provide the procedure, under what circumstances and how. The potential spectrum of provision is wide. On one end lies a strictly supervised procedure with direct physician provision and administration of the drugs and several clinic visits entailing ultrasound, blood draws and bimanual exams. At the other end lies a simplified procedure with very limited supervision, involving self-screening, self-administration of the drugs and one or no clinic visits.

In most places, the reality of service provision, owing to legal and resource constraints, is that women who can not access health services in an ideal manner are denied the promise of medical abortion. While practice has slowly evolved away from the strictest model of medical supervision, the standard of care is still highly controlled [3–5]. By contrast, a large body of research and clinical experience demonstrates that women are capable of managing the procedure under very limited medical supervision and, thus, validates more flexible practice choices.

Moving away from highly controlled, medically supervised procedures will greatly benefit women, opening the door to more effective utilization of this important technology to maximize women's health. Adopting separate approaches – one for women who have access to some level of medical supervision and another for those who have little or none – may speed progress. Arguably, one key to safe and successful management of early medical abortion is access to information and guidance, as opposed to strict medical supervision per se.

‘Moving away from highly controlled, medically supervised procedures will greatly benefit women, opening the door to more effective utilization of this important technology to maximize women's health.’

As research has demonstrated time and time again, regardless of the legality and availability of safe services, women will seek abortions and, if necessary, resort to unsafe procedures or self-induction [6]. Thus, at a minimum, clear, appropriate information on the procedure should be easily available to women in settings where abortion is legally restricted or where services are unsafe and/or difficult to access.

Clinically, early medical abortion is a simple procedure with few serious complications, very low morbidity and exceedingly rare mortality [7,8]. The process induced by this method is similar to spontaneous abortion, involving bleeding and cramping followed by the expulsion of embryonic products (usually within 24 h following misoprostol administration). Additionally, women generally experience minor side-effects related to the drugs, including worsening of pregnancy-related symptoms, diarrhea, fever and chills. These effects are transient – only very rarely requiring administration of medications, such as antipyretics or antiemetics [9]. As with spontaneous abortion, hemorrhage and infection occur rarely following medical abortion. Generally, these complications can be managed with simple interventions (such as oral antibiotics or manual vacuum aspiration) that can be provided by less-skilled practitioners. In extremely rare cases they can be life-threatening and require interventions, such as intravenous antibiotics or a transfusion.

As outlined below, women have the capacity to carry out the steps needed to ensure safe and effective procedures. In fact, pregnant women often face the risks inherent in medical abortion regardless of whether they undergo the procedure or continue their pregnancies. The key is to arm women with the tools to understand and manage the procedure and its complications.

Women can know the gestational age of their pregnancies

The majority of outpatient, early medical abortion practice is limited to women of less than 9 weeks' gestation, since beyond that gestation age there is a higher risk of method failure and more severe side-effects, such as pain and bleeding [10,11]. For this reason, women must be able to know well enough that they are less than 9 weeks' gestation, even if they are not able to estimate the duration exactly.

Providers generally employ a range of techniques to date a pregnancy, including vaginal ultrasound, clinical exam and reported date of the last menstrual period. To screen themselves, women should have access to home pregnancy tests, have sufficient knowledge of their menstrual cycles and know their sexual history. Research shows that women who have regular menstrual cycles are generally capable of estimating the length of gestation within a reliable margin of error. Several studies suggest that the majority of women (typically more than 90%) are able to calculate gestational age within a margin of error inconsequential to the safety and efficacy of medical abortion, for example very few estimate a pregnancy greater than 9 weeks' gestation to be less than 9 weeks [12–14]. Research also demonstrates the benefit of a self-screening instrument in reducing the frequency of underestimation [14].

‘…the key is to arm women with the tools to understand and manage the procedure and its complications.’

Thus, policy-makers and providers can be assured that women will not widely underestimate the length of gestation. Even where women do underestimate gestational age, serious clinical consequences are unlikely to occur, since the medications are highly safe and effective through the first trimester. Although method failure is more common and side-effects may be more severe in women greater than 9 weeks gestation, serious adverse events (such as major hemorrhage or systemic infection) are not more common [10,11]. With respect to dating pregnancies, the key is for women to be aware that they should seek additional supervision if they do not have regular cycles, can not remember the date of their last menstrual period, are prone to nonmenstrual bleeding, or do not know the suspected date of sexual activity.

Women can understand contraindications

One beneficial aspect of early medical abortion with mifepristone and misoprostol is that it has very few contraindications, which makes limited supervision possible [15]. With the exception of nonuterine pregnancy, contraindications are based on medical history. For this reason, the vast majority of women are aware when they have a contraindicated condition, such as an intra-uterine device in place, chronic adrenal failure, concurrent long-term corticosteriod therapy, history of allergy to mifepristone, misoprostol or other prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy.

Failure to diagnose ectopic pregnancy could have life-threatening consequences if women do not seek medical attention. Yet even strict supervision during a medical abortion procedure only facilitates earlier detection and treatment. Ectopic precautions and information about seeking referral for more definitive diagnoses can be part of the information provided to women who use the technology, and also may be effective at prompting earlier detection and treatment. In fact, even ultrasound exams in early pregnancy can fail to reveal existing ectopic pregnancies, as was the case with the one US fatality from a ruptured ectopic after use of mifepristone [8]. Despite a negative ultrasound, this woman had clear symptoms that impelled providers to refer her for urgent care, which she refused to seek. Nonetheless, the vast majority of women in early pregnancy do not seek abortion services and will only seek care for ectopic pregnancy when they experience symptoms. Thus, failure to diagnose ectopic pregnancy among women undergoing early medical abortion does not put a woman at greater risk for rupture per se, even if ideally women were to be screened for ectopic pregnancy prior to administering the drugs.

Women can follow prescribed regimens

Studies of medical abortions demonstrate that few women fail to follow prescribed regimens, even where they self-administer drugs at home [16–18] and where regimens are more complicated, such as those with multiple misoprostol doses [19–21]. Women who present for abortion are highly motivated to follow prescribed therapies and, with sufficient information, have the ability to do so. Moreover, regimens tend to be highly ‘forgiving’ in terms of safety and efficacy, as a range of mifepristone–misoprostol regimens result in comparable efficacy and safety. First, doses of mifepristone between 200 and 600 mg have been proven equally effective [22], and mifepristone is only available in 200-mg tablets, thus, it is unlikely that women would administer an insufficient dose of mifepristone.

‘…it is conceivable that with sufficient and clear information, and possibly, access to misoprostol, the majority of women with incomplete abortion could effectively manage incomplete abortion with little or no supervision.’

Second, the effective window between mifepristone and misoprostol doses is relatively wide – 6–72 h. Evidence shows that there is little variability in efficacy among women administering mifepristone within that window [23–25]. Furthermore, data from studies indicate that only rarely does a woman fail to take misoprostol within the prescribed window. Most often when a woman fails to do so it is either because she believes her abortion is complete or she has changed her mind about the procedure.

Finally, a range of misoprostol regimens is effective following mifepristone. While some regimens do appear to result in higher efficacy, many regimens show an overall efficacy of at least 90% [16–25]. Evidence suggests that the efficacy of most regimens begins to decline among women beyond 8 weeks' gestation [21,26]. The decline appears greatest for regimens where misoprostol is swallowed (taken orally). However, accommodations in misoprostol dosing – route, dose and number of doses – could be tailored to women using the method in less supervised settings so as to maximize efficacy and safety.

Women can access medical assistance when necessary

It is rare that a woman undergoing an abortion and in need of urgent treatment will fail to seek medical help. The complications requiring supervised intervention are systemic infection and major hemorrhage and occur in approximately one in 5000–10,000 procedures [7,8] – the signs and symptoms of which are usually obvious to women. One concern, however, is where life-threatening conditions are difficult to self-diagnose in time for treatment to be effective; yet this sort of complication is extremely rare following medical abortion. In the USA and Canada, several cases of postabortal infection with Clostridium sordellii have resulted in rapid, fatal toxic shock, with few of the usual signs of severe infection, such as prolonged fever or severe pain [27–29]. No such cases have been reported in other countries. While the seriousness of these infections can not be ignored, their extreme rarity (fewer than one in 100,000 procedures), geographic specificity and uniform fatality despite early and heroic intervention all suggest that more restrictive provision of the method would be of no benefit to women. In jurisdictions where women frequently face equally serious complications associated with the available alternatives, including for some women continuing with a pregnancy, witholding mifepristone would deny those women a beneficial health intervention.

Researchers, providers and policy-makers are concerned with consequences of incomplete abortion and continuing pregnancy, since in rare cases either outcome can result in morbidity and mortality. For incomplete abortion, expectant or medical management with misoprostol is a highly effective, and often preferable, alternative to surgery [30–32]. Thus, it is conceivable that with sufficient and clear information, and possibly, access to misoprostol, most women with incomplete abortion could effectively manage this condition with little or no supervision. For continuing pregnancy, women must be aware that the possibility for fetal malformation exists, in particular as a result of misoprostol exposure during the early first trimester [33–35]. However, the risk of congenital anomaly is so small that researchers are unable to estimate its incidence. Careful consideration shows that the benefit of the method may not be outweighed by the extremely rare risk of congenital anomaly. Nonetheless, regardless of the extent of available supervision, all women should be counseled about this risk.

By and large, the more pressing concern is management of serious complications for women living in places where access to treatment is difficult if not impossible. Women living in these jurisdictions face a complex calculus of risk assessment, as frequently safe abortion services are also inaccessible. The dilemma is whether to:

• Utilize a method with well-established safety and effectiveness, but with little supervision;

• Utilize an alternate method of abortion, usually with questionable safety or effectiveness;

• Continue with the pregnancy.

Life-threatening complications are associated with all three choices – so it is not possible to entirely eliminate the risk that women in these circumstances face, even if that is the ideal goal.

In conclusion, while any negative consequences of medical abortion can theoretically be limited by controlling the procedure through legal restrictions and strict medical regulations, there is no evidence that is actually the case. Furthermore, the impact of risks associated with either unsafe, often clandestine abortion by other methods or birth arguably can not be reduced by such measures. Therefore, the argument that we can eliminate risks by denying women services has little currency. The key to improving women's lives is empowering informed choice; with respect to medical abortion, this does not mean further regulating or restricting its availability. Indeed, for many women the best choice – meaning the safest and most effective – will be to administer mifepristone and misoprostol with little or no medical supervision. The step forward is to ensure women can make that choice with adequate information and as much assistance as is feasible and desirable.