Simplifying medical abortion services in primary care settings in India

Abstract: Background: Even in countries where abortion is legal, many women suffer mortality and morbidity from unsafe abortion. When faced with an unwanted pregnancy, women encounter many social, geographical, and health system level barriers in accessing safe abortion. Medical methods are far more amenable to be provided in primary care rural settings, however, in practice, women are required to make multiple clinic visits to receive medical abortion services. Two important measures to reduce the number of clinic visits after an early medical abortion, are eliminating the second visit by allowing home use of misoprostol and eliminating the third visit by allowing women to assess the outcome of their abortion on their own. However, most research on home use of misoprostol and on alternatives to routine clinic follow-up visits has been done in high-income countries or in urban areas of developing countries. There is little evidence on efficacy, safety and acceptability of home use of misoprostol and self-assessment approaches from rural areas of low resource settings. Objectives: The aims of this research were: (a) to assess the efficacy, feasibility, safety and acceptability of self assessment as compared to the routine clinic follow-up after early medical abortion, (b) to assess efficacy, safety and acceptability of home administration of misoprostol as compared to clinic use of misoprostol, and (c) to explore women’s experiences and perceptions of home use of misoprostol and of self-assessment of outcome of early medical abortion. Methods: The study was conducted in southern part of Rajasthan state in India, where 75% population is rural and only about half the women are literate. A randomised controlled, noninferiority trial was conducted at 6 health centres (3 rural, 3 urban) in 2013-14. Women seeking early medical abortion up to 9 weeks gestation were randomly assigned either to routine clinic follow-up or to self-assessment using a low-sensitivity pregnancy test at home. They were contacted through a home visit or phone call, 10-15 days later, to record the outcome of the abortion. The primary outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone /misoprostol. The non-inferiority margin for the risk difference was 5%. Secondary outcomes included safety, feasibility, interim visits, and acceptability. A secondary analysis of the data was carried out to compare the outcomes among women with home and clinic administration of misoprostol. In-depth interviews were conducted with 20 women who administered misoprostol at home and assessed their own outcome of abortion using a low-sensitivity pregnancy test, to explore their perceptions and experiences. Results: In the randomised controlled trial, 731 participants were recruited, of whom 700 were analysed for primary outcome (had a recorded primary outcome and who followed the clinical protocol). Overall rates of complete abortion, incomplete abortion and on-going pregnancy were 94.3%, 4.7% and 1.0%. Comparison of women in the clinic follow-up group and the home assessment groups showed that complete abortion rates and rates of surgical intervention were similar between the two groups, and that home assessment is non-inferior iii to clinic follow-up after an early medical abortion. Adverse outcomes were extremely rare in both groups. Eighteen percent of women made an interim visit. 80% women did the low-sensitivity pregnancy test on their own, without any reminder. Overall, 96% were satisfied with their medical abortion experience and there were no differences between the study groups. Significantly more women in the home-assessment group preferred home-assessment in the future, as compared with women in the clinic follow-up group, who preferred clinic followup in the event of a future medical abortion (p= 0.001). Comparison of women using home and clinic misoprostol groups showed that the outcomes related to efficacy, safety and satisfaction rates were comparable between the two groups. Non-compliance with use of misoprostol was higher among women assigned to clinic user than those assigned to home user (3.6% and 0.6% respectively). The time spent on clinic visits and travel was 5 hours extra for clinic users as compared to home users. A significantly greater proportion of home users said that they would opt for misoprostol at home in the event of a future abortion, than the proportion of clinic users that would opt for misoprostol at the clinic, in a similar situation (p= 0.0002). In-depth interviews revealed that almost all women preferred home use of misoprostol, since it allowed them to maintain confidentiality and to avoid difficulties related to childcare, housework and inconvenience of travel. On the day of misoprostol, women were confidently able to manage their abortions, and continue with routine housework. Even though most women were able to understand the outcome of their abortion through symptoms, they found it reassuring to do the pregnancy test to alleviate anxieties about retained products. Majority said they would prefer medical abortion involving a single visit in future. Conclusion: Our results confirm that self-assessment using low-sensitivity pregnancy test is an effective and safe approach to identify women with on-going pregnancies after an early medical abortion. Further, these studies also confirm that women are capable of administering misoprostol at home, without reduction in efficacy or safety. Women can confidently administer misoprostol at home, can conduct assessment of their abortion outcomes, and find it highly acceptable. Evidence generated by these studies is the only evidence thus far from a low resource rural setting that women with low literacy levels can feasibly assess the outcome of an early medical abortion and can safely use misoprostol at home. Service delivery guidelines should be revised and offer women a choice between home and clinic use of misoprostol and between self-assessment and clinic follow-up. In health systems, reducing the number of clinic visits would greatly enhance women’s access to safe abortion. Greater self-management of medical abortions would require that health systems enable and equip women with necessary information and supplies, and are available to provide backup care.