Abstract
ObjectiveTo examine the effectiveness, safety, and acceptability of nurse provision of early medical abortion compared to physicians at three facilities in Mexico City.MethodsWe conducted a randomized non-inferiority trial on the provision of medical abortion and contraceptive counselling by physicians or nurses. The participants were pregnant women seeking abortion at a gestational duration of 70 days or less. The medical abortion regimen was 200 mg of oral mifepristone taken on-site followed by 800 μg of misoprostol self–administered buccally at home 24 hours later. Women were instructed to return to the clinic for follow-up 7–15 days later. We did an intention-to-treat analysis for risk differences between physicians’ and nurses’ provision for completion and the need for surgical intervention.FindingsOf 1017 eligible women, 884 women were included in the intention-to-treat analysis, 450 in the physician-provision arm and 434 in the nurse-provision arm. Women who completed medical abortion, without the need for surgical intervention, were 98.4% (443/450) for physicians’ provision and 97.9% (425/434) for nurses’ provision. The risk difference between the group was 0.5% (95% confidence interval, CI: −1.2% to 2.3%). There were no differences between providers for examined gestational duration or women’s contraceptive method uptake. Both types of providers were rated by the women as highly acceptable.ConclusionNurses’ provision of medical abortion is as safe, acceptable and effective as provision by physicians in this setting. Authorizing nurses to provide medical abortion can help to meet the demand for safe abortion services.
Highlights
In Mexico City, early elective abortion to terminate pregnancy was legalized in April 2007.1–3 Up to June 2013, 100 000 abortions have been provided by trained physicians in Ministry of Health hospitals and clinics.[4]
We assumed that physicians and nurses would achieve a 95% completion rate for medical abortions, based on a previous randomized controlled trial[11] and a meta-analysis on medical abortion efficacy which found successful medical abortion rates using the mifepristone-misoprostol regimen between 91% to 96% depending on gestational duration.[18]
We calculated two scenarios where we hypothesized the outcome for the women lost to follow-up and our results demonstrated that nurses were not inferior to physicians when providing medical abortion (Table 4)
Summary
We conducted a randomized controlled non-inferiority trial between November 2012 and January 2013 at two Mexico City Ministry of Health abortion clinics and one hospital. We used the medical abortion regimen recommended by Mexico City Ministry of Health,[23] which differs from WHO’s recommendation.[24] Pregnant women with a gestational duration determined as less than 70 days were given 200 mg of oral mifepristone under supervision followed by instructions to self–administer four tablets of misoprostol (200 μg each) buccally at home, 24 hours later. If the provider determined that the woman had an ongoing pregnancy or incomplete abortion –such as continued bleeding, tissue residue or cramps – participants were offered an additional 800 μg of misoprostol administered at the clinic or hospital, according to Mexico City Ministry of Health practice.[25] If women requested a manual vacuum aspiration or the provider felt it was warranted – due to remaining fetal tissue, persistent gestational sac or continuation of pregnancy – it was provided on-site by an obstetrician who was not part of the study. All analyses were conducted using SPSS version 18.0 (SPSS Inc., Chicago, USA).[26]
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