No abstract

Background 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). Methods In 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. Results Over 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. Conclusion These 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.

IntroductionA range of barriers deter or prevent people from accessing facility-based abortion care. As a result, people are obtaining and using abortifacient medications to end their pregnancies outside of the formal healthcare system, without clinical supervision. One model of self-managed abortion has come to be known as the ‘accompaniment’ model, in which grassroots organisations provide pregnant people with evidence-based counselling and support through the medication abortion process. Data are needed to understand the safety and effectiveness of this increasingly common model of abortion care.Methods and analysisThis is a large, prospective, observational study in Argentina and Nigeria. All people who contact one of two accompaniment groups seeking information for their own self-managed medication abortion, are ages 13 years and older, have no contraindications for medication abortion, are within the gestational range supported by the group (up to 12 weeks’ gestation for the primary outcome) and are willing to be contacted for follow-up will be recruited. Participants will respond to an interviewer-administered baseline survey at enrolment, and 1–4 additional surveys over 6 weeks to ascertain whether they obtain medications for abortion, dosing and route of administration of medications, physical and emotional experience of medication abortion self-management, and effectiveness and safety outcomes. Analyses will include estimates of the primary outcome: the proportion of participants that report a complete abortion without surgical intervention at last recorded follow-up; as well as secondary outcomes including a pseudo-experimental test of non-inferiority of the effectiveness of self-managed medication abortion as compared with clinical medication abortion.Ethics and disseminationWe describe the ethical considerations and protections for this study, as well the creation of a study-specific Data Monitoring and Oversight Committee. We describe dissemination plans to ensure that study results are shared widely with all relevant audiences, particularly researchers, advocates, policymakers and clinicians.Trial registration numberISRCTN95769543.

Objective To investigate the impact of a smartphone application (app) providing information and support for medication abortion (MA) on the primary outcomes of ‘feelings of support’ and ‘preparedness’ among clients of Samsara, a safe‐abortion hotline in Indonesia. Methods In a parallel‐arm, non‐clinical, randomized controlled trial, women (ages ≥15) who contacted Samsara between February 2017‐ July 2018 seeking information on MA for pregnancies ≤13 weeks gestation were randomized to receive either an app with abortion information, or standard of care (high‐quality comprehensive and empathic counseling on pregnancy options). Participants completed a questionnaire 24 days after enrollment; Fisher exact tests and risk differences were used to assess differences in self‐reported feelings of preparedness and support throughout the process of self‐managed MA. Results No differences in feelings of support or preparedness were detected between participants in the app arm versus the standard of care arm. Conclusion This study represents the first‐ever randomized control trial (and prospective study) among those who contacted a safe‐abortion hotline for information about and support for self‐managed abortion. Levels of preparedness, confidence, and feelings of support were all extremely high among both control and intervention arms–indicative of the high‐quality, evidence‐based information, comprehensive, and supportive abortion counseling that safe‐abortion hotline clients receive.

Globally, people self-manage their medication abortions without clinical assistance. Feminist activist collectives (accompaniment groups) support people through self-managed abortion with evidence-based guidance. We sought to understand the impact of COVID-19 and related restrictions on the need for and experiences of self-managed abortion with accompaniment support across varied legal and social contexts. Between May and October 2020, we conducted in-depth interviews with individuals who self-managed abortions with support from accompaniment groups during the pandemic in Argentina, Indonesia, Nigeria, and Venezuela. We conducted a thematic analysis to understand the impact of COVID-19 on participants’ experiences with accompanied self-managed abortions. Across 43 in-depth interviews, participants in all four countries described how the COVID-19 pandemic created challenges at each step of their abortion process, from confirming the pregnancy, accessing abortion pills, finding a private, comfortable place, and verifying abortion completion. For most people, conditions related to the pandemic made it harder to self-manage an abortion; for a minority, being at home made aspects of the experience somewhat easier. Nonetheless, all participants reported feeling supported by accompaniment groups, and COVID-19 and related lockdowns reinforced their preference for accompaniment-supported self-managed abortion. These findings highlight the essential role that accompaniment groups play in ensuring access to high-quality abortion care in a multiplicity of settings, particularly during the COVID-19 pandemic. Efforts are needed to expand the reach of accompaniment groups to increase access to the high-quality abortion support they provide, filling a critical gap left by health systems and legal infrastructure.