Original Research ArticleSide effects of mifepristone-misoprostol abortion versus surgical abortion: Data from a trial in china, cuba, and india
Introduction
Over the past decade, several safe and effective medical abortion regimens have been developed.1, 2, 3 The most widely used regimen consists of 600 mg mifepristone followed two days later by 400 μg oral misoprostol. This regimen has been available in France for >6 years,1 received “approvable status” from the United States Food and Drug Administration in 19964 and has been tested in several developing countries as well.5, 6 Despite varied experiences with the method across different cultures, women consistently report the method’s side effects, including bleeding and pain, among its worst features.6, 7, 8
Much of the existing literature on side effects of medical abortion is limited to serious adverse events or to a cursory mention of the more common side effects. Indeed, aside from four articles investigating blood loss experienced with various mifepristone regimens,9, 10, 11, 12 no thorough analysis of the method’s side effects, including when they occur during the abortion process, how they affect patient acceptability, and how they compare with those experienced in connection with surgical abortion, has been undertaken. Yet, these factors typically govern women’s experiences as much as the rare serious adverse event. In some cases, in fact, side effects of medical abortion are considered so unpleasant or severe as to negate the advantages the method offers over surgical alternatives. Indeed, women who initially select medical abortion in preference to surgical abortion may even request a surgical intervention to halt these side effects.13
Using data from a comparative trial of medical and surgical abortion, women’s experiences with side effects were investigated in three developing countries. A fuller exposition of this topic is in order for several reasons, particularly if based on an international, multicenter, acceptability and feasibility comparative trial. First, as access to medical abortion is increased, side effects must be well understood so that proper training and counseling materials can be developed. Realistic expectations are essential for the method to be used by suitable providers and clients, and to minimize anxiety and unnecessary surgical interventions once treatment begins. Second, as regulatory decisions and clinical protocols for medical abortion are typically based in part on the side effect profile of the method, accurate documentation of the severity and incidence of side effects is critical, as is a context for understanding this profile. Third, reporting of side effects and reactions to them vary across cultures. Assessing women’s experiences with side effects and their acceptability in three countries simultaneously can highlight commonalties and differences. A nuisance side effect in one population may be entirely unacceptable in another. Finally, the medical literature on side effects experienced with surgical abortion is scanty, particularly with respect to the experiences of women in developing countries and in comparison with new medical abortion regimens. Indeed, protocols for managing side effects, such as pain, may differ greatly in developed and developing countries, contributing to a very different user experience with the two methods. A comparative analysis using data from three developing countries will help build this literature.
Section snippets
Materials and methods
Data were analyzed from a large international comparative study of mifepristone-misoprostol medical abortion and surgical abortion held in China, Cuba, and India. Six urban clinics participated in the study, which ran from October 1991 to August 1993. All clinics already offered legal first-trimester surgical abortion services and followed a uniform study protocol approved by the Population Council’s Institutional Review Board. Women with pregnancy durations of ≤56 days (based on the onset of
Sample characteristics and failure rates
Table 1 provides characteristics of the 1373 participants, as well as failure rates, by site, and method. “Failure” is defined as referring to any medical client who received a surgical intervention (whether on request, deemed medically necessary during the study, or for an ongoing pregnancy or incomplete abortion at the study end), and any surgical client who received a second surgical intervention. In all sites, surgical abortion was more effective than medical abortion. Sites that had high
Discussion
To compare medical and surgical abortions, the intended effects (or “symptoms”) of mifepristone and misoprostol need to be separated from the true “side effects” of the treatment. Just as topical anesthesia creates an intended effect of numbness to alleviate pain, the mifepristone-misoprostol regimen causes bleeding and abdominal cramping to provoke early abortion. Considering these features as “symptoms” rather than “side effects” (as is traditionally done) can guide the development of
Acknowledgements
We thank the women and clinicians who participated in the clinical trial on which this analysis is based and are grateful to Kelly Blanchard for comments on an earlier draft of this paper.
This research was funded in part by a grant from an anonymous donor and in part by the Population Council.
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Physical symptoms and emotional responses among women undergoing induced abortion protocols during the second trimester
2016, International Journal of Gynecology and ObstetricsKnowledge, attitudes, and practices of certified providers of medical abortion: Evidence from Bihar and Maharashtra, India
2012, International Journal of Gynecology and ObstetricsSimultaneous use of mifepristone and misoprostol for early pregnancy termination
2011, Taiwanese Journal of Obstetrics and GynecologyCitation Excerpt :However, we envisaged in this study the use of a lower dose of misoprostol in order to reduce any adverse effects. Evidence suggests that any adverse effects associated with early pregnancy terminations using mifepristone and misoprostol, such as nausea, gastrointestinal complaints, and pain from cramping, may be related to the dose of misoprostol and the route by which it is administered [10]. Vaginal administration of misoprostol 800 μg seems to have more adverse effects in previously published reports [11–13]; therefore, this had led to investigate the efficacy of mifepristone 200 mg and misoprostol 600 μg vaginally in order to determine the effectiveness and its adverse events of this procedure on early medical abortion.
Support for provision of early medical abortion by mid-level providers in Bihar and Jharkhand, India
2009, Reproductive Health MattersInitial Loss of Productive Days and Income Among Women Seeking Induced Abortion in Cambodia
2008, Journal of Midwifery and Women's HealthCitation Excerpt :Three studies have examined time or productivity lost because of induced abortion. In the only study on this topic conducted in developing countries, authors compared physical restrictions (or the inability to undertake daily routine activities) for women who had abortions, and found these to be an average of 5 days for Chinese women and 3.2 days for Cuban women.12 Within the context of public sector abortion services in Canada, Wiebe and Janssen8 compared women’s time lost because of a surgical versus a medical abortion, and estimated an average loss of work inside the home of 10 days for the surgical group and 5.3 days for the medical group.
Increasing access to safe abortion services in rural India: experiences with medical abortion in a primary health center
2007, ContraceptionCitation Excerpt :While our study did not aim to assess the safety and effectiveness of sublingual misoprostol following mifepristone, our high success rate (98.6%), particularly notable in a rural setting among providers with no previous medical abortion experience, suggests that further attention should be paid to this route of administration. While the prevalence of side effects reported in this study was only marginally higher than that reported in other medical abortion studies conducted in India using a similar dose of oral misoprostol [4,14], a randomized controlled trial comparing 800 μg sublingual and vaginal misoprostol following 200 mg mifepristone noted statistically significant higher rates of fever, chills and gastrointestinal side effects among women who received sublingual administration and higher rates of fever and chills than noted in our study [15]. Given this, researchers should consider including a regimen of 200 mg mifepristone followed by a reduced 400-μg dose of sublingual misoprostol in future double-blinded randomized controlled trials examining the optimal route and dose of misoprostol.