Elsevier

Contraception

Volume 59, Issue 2, February 1999, Pages 107-114
Contraception

Original Research Article
Side effects of mifepristone-misoprostol abortion versus surgical abortion: Data from a trial in china, cuba, and india

https://doi.org/10.1016/S0010-7824(99)00003-7Get rights and content

Abstract

Although serious adverse events of early abortion have been studied, little attention has been paid to the more common side effects experienced by early medical or surgical abortion clients. Using data from a multicenter comparative trial of women ≤56 days’ gestation in China, Cuba, and India (n = 1373), side effects experienced by mifepristone-misoprostol medical abortion and surgical abortion clients were analyzed at the different stages of their abortions. Data on side effects came from women’s reports at each clinic visit, providers’ observations during the clinic visits, and symptom diaries maintained during the study period. Medical abortion clients at all sites experienced more side effects than their surgical counterparts. The disparity between the two groups was particularly pronounced for bleeding and pain. Despite more reports of side effects among medical abortion clients, however, assessments of well-being and reports of satisfaction at the exit interview were similar in both treatment groups.

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.

References (15)

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    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.

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