Abstract
BackgroundTo evaluate the feasibility of conducting a prospective study to measure self-managed medication abortion outcomes, and to collect preliminary data on safety and effectiveness of self-managed medication abortion, we recruited callers to accompaniment groups (volunteer networks that provide counselling through the out-of-clinic medication abortion process by trained counselors over the phone or in-person).MethodsIn 2019, we enrolled callers to three abortion accompaniment groups in three countries into a prospective study on the safety and effectiveness of self-managed medication abortion with accompaniment support. Participants completed up to five interview-administered questionnaires from baseline through 6-weeks after taking the pills. Primary outcomes included: (1) the number of participants enrolled in a 30-day period, (2) the proportion that had a complete abortion; and (3) the proportion who experienced any warning signs of potential or actual complications.ResultsOver the 30-day recruitment period, we enrolled 227 participants (95% of those invited), and retained 204 participants (90%) for at least one study follow-up visit. At the 1-week follow-up, two participants (1%) reported a miscarriage prior to taking the pills, and 202 participants (89% of those enrolled and 99% of those who participated in the 1-week survey) had obtained and taken the medications. Three weeks after taking the medications, 192 (95%) participants reported feeling that their abortion was complete. Three (1.5%) received a surgical intervention, two (1%) received antibiotics, and five (3%) received other medications. Participants did not report any major adverse events.ConclusionThese results establish the feasibility of conducting prospective studies of self-managed medication abortion in legally restrictive settings. Further, the high effectiveness of self-managed medication abortion with accompaniment support reported here is consistent with high levels of effectiveness reported in prior studies.Trial registration ISRCTN95769543.
Highlights
To evaluate the feasibility of conducting a prospective study to measure self-managed medication abortion outcomes, and to collect preliminary data on safety and effectiveness of self-managed medication abortion, we recruited callers to accompaniment groups
The primary aims of this pilot study were to (1) assess the feasibility of implementing a prospective study to recruit and follow callers to abortion accompaniment groups; and (2) evaluate hypotheses about the effectiveness and experiences of self-managed abortion under this model of care. While these data come from a pilot study, so do not represent results that are powered to make definitive statements about safety, these data provide foundational evidence for future studies on selfmanaged abortion, as we find ourselves in a moment of history where delivery of healthcare services by the formal sector will require innovation, and where healthcare infrastructures around the globe will be challenged in unknowable ways [26, 27]
Use of medication abortion pills At the 1-week follow-up, 203 participants (89% of those enrolled and 99% of those who participated in the 1-week survey) had obtained the medication—just under half of these 203 participants reported obtaining the medication from a pharmacy (n = 97, 49%)
Summary
To evaluate the feasibility of conducting a prospective study to measure self-managed medication abortion outcomes, and to collect preliminary data on safety and effectiveness of self-managed medication abortion, we recruited callers to accompaniment groups (volunteer networks that provide counselling through the out-of-clinic medication abortion process by trained counselors over the phone or in-person). Given the barriers to abortion access in clinical settings, those in need of abortion care are increasingly obtaining mifepristone and misoprostol, World Health Organization (WHO) recommended medications for abortion [5], through informal sector routes including online services, pharmacies, hotlines, and drug sellers [6,7,8,9,10]. Much of the published literature has focused on the experiences of self-managed medication abortion with telemedicine support from online websites that provide access to pills as well as information on how to use them via email communication; these studies report safe and effective abortion experiences [2, 8, 12, 13, 16,17,18]
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