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.
In Argentina, Chile and Ecuador, abortion at later durations of pregnancy is legally restricted. Feminist collectives in these contexts support people through self-managed medical abortion outside the healthcare system. The model of in-person abortion accompaniment represents an opportunity to examine a self-care practice that challenges and reimagines abortion provision. We formed a collaborative partnership built on a commitment to shared power and decision-making between researchers and partners. We conducted 28 key informant interviews with accompaniers in Argentina, Chile and Ecuador in 2019 about their model of in-person abortion accompaniment at later durations of pregnancy. We iteratively coded transcripts using a thematic analysis approach. Accompaniers premised their work in a feminist activist framework that understands accompaniment as addressing inequalities and expanding rights, especially for the historically marginalised. Through a detailed description of the process of in-person accompaniment, we show that the model, including the logistical considerations and security mechanisms put in place to ensure favourable abortion outcomes, emphasises peer-to-peer provision of supportive physical and emotional care of the accompanied person. In this way, it represents supported self-care through which individuals are centred as the protagonists of their own abortion, while being accompanied by feminist peers. This model of supported self-care challenges the idea that “self-care” necessarily means “solo care”, or care that happens alone. The model’s focus on peer-to-peer transfer of knowledge, providing emotional support, and centring the accompanied person not only expands access to abortion, but represents person-centred practices that could be scaled and replicated across contexts.
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