Self-managed medication abortion trajectories: results from a prospective observational study in Argentina, Nigeria and Southeast Asia.

OBJECTIVES: Time is a crucial factor in abortion-seeking because options for care change with pregnancy duration, and most people prefer to access abortion care early in pregnancy. We aimed to collect data on the timing of steps in accompanied self-managed abortion-seeking experiences in legally restrictive settings. METHODS: In this prospective, observational, cohort study we recruited callers from three abortion accompaniment groups in Argentina, Nigeria and a country in Southeast Asia. Participants completed a baseline survey before starting a self-managed medication abortion (SMA) and two follow-up surveys (approximately 1 and 3 weeks after taking medication). Primary outcomes of interest included: (1) time from abortion decision to contacting the hotline, (2) time from contacting the hotline to obtaining pills and (3) time from obtaining pills to taking the first dose. We explored relationships between participant characteristics and each of these outcomes and evaluated differences in overall abortion time using survival analyses. RESULTS: Between July 31, 2019 and October 01, 2020 we enrolled 1352 eligible callers; 1148 provided data for this analysis. After deciding to have an abortion, participants took 12.2 days on average (95% CI: 11.6, 12.9) to start medications for abortion. On average, participants at later pregnancy durations progressed through the SMA process more quickly (<4 weeks: 20.9 days, 4 weeks: 11 days, 5-6 weeks: 10.1 days, 7-9 weeks, 10.4 days, 10+ weeks: 9.1 days; p<0.001). CONCLUSIONS: Overall, participants accessed accompaniment group support and started abortion regimens quickly and at relatively early pregnancy durations. SMA with accompaniment provided a time-efficient route for obtaining abortions.

Effectiveness of Self-Managed Medication Abortion Between 9 and 16 Weeks of Gestation.

OBJECTIVE: To evaluate abortion completion after self-managed medication abortion in pregnancies at or beyond 9 weeks of gestation. METHODS: We conducted a prospective observational cohort study in which we recruited callers to three abortion-accompaniment groups in Argentina, Nigeria, and Southeast Asia who were initiating a self-managed medication abortion. Participants completed a baseline survey over the phone before taking pills and then two follow-up phone surveys 1 and 3 weeks after taking pills. The primary outcome was abortion completion; secondary outcomes included physical experiences and health care seeking and treatment. RESULTS: Between 2019 and 2020, we enrolled 1,352 participants, 19.5% (264/1,352) of whom self-managed a medication abortion at 9 or more weeks of gestation: 75.0% (198/264) at 9-11 weeks, 19.3% (51/264) at 12-14 weeks, and 5.7% (15/264) at 15-22 weeks. Participants were aged 26 years on average (SD 5.6 years); 56.4% (149/264) used the combined regimen (mifepristone+misoprostol), and 43.6% (115/264) used misoprostol only. At the last follow-up, 89.4% (236/264) had a complete abortion without procedural intervention, 5.3% (14/264) had a complete abortion with manual vacuum aspiration or dilation and curettage procedure, 4.9% (13/264) had an incomplete abortion, and 0.4% (1/264) participants did not report an abortion outcome. Some participants (23.5%, 62/264) sought health care during or after the self-managed medication abortion, most commonly to confirm completion (15.9%, 42/264); 9.1% (24/264) needed further medical intervention (procedural evacuation, antibiotics, additional misoprostol, intravenous fluids, blood transfusion, or overnight stay in the facility). Those who were 12 or more weeks pregnant were more likely to seek care at a clinic or hospital than those who were 9-11 weeks pregnant (adjusted relative risk 1.62, 95% CI 1.3-2.1). CONCLUSION: People who self-managed an abortion with medication between 9 and 16 weeks of gestation had high levels of abortion completion and accessed health care to confirm completion or to treat potential complications. CLINICALTRIALREGISTRATION: ISRCTN, ISRCTN95769543.

Respondent-Driven Sampling for Estimation of the Cumulative Lifetime Incidence of Abortion in Soweto, Johannesburg, South Africa: A Methodological Assessment.

Respondent-driven sampling (RDS) is a potential strategy for addressing challenges in accurate estimation of abortion incidence, but it relies on often untested assumptions. We conducted an RDS study to estimate the cumulative lifetime incidence of abortion in Soweto, Johannesburg, South Africa (April-December 2018), to evaluate whether RDS assumptions were met, and to compare RDS estimates of incidence with estimates adjusted for employment and age based on census data. A total of 849 participants were recruited from 11 seed participants between April and December 2018. The assumption that individuals can identify target population members and the assumption of approximation of sampling with replacement was met. There were minor violations of the assumptions of seed independence from the final sample and reciprocity of ties. Assumptions of accurate degree reporting and random recruitment were not met. Failure to meet assumptions yielded a study sample with different employment characteristics than those of the target population; this could not be resolved by standard RDS methods. The RDS estimate of cumulative lifetime abortion incidence was 12.1% (95% confidence interval: 9.8, 14.3), and the employment-adjusted estimate was 16.9% (95% confidence interval: 12.8, 22.1). We caution researchers in using RDS for representative estimates of abortion incidence. Use of postsurvey weights to adjust for differences in characteristics between the sample and the target population may yield more representative results.

Incidence of and Experiences with Abortion Attempts in Soweto, South Africa: Respondent-Driven Sampling Study.

BACKGROUND: Estimation of abortion incidence, particularly in settings where most abortions occur outside of health facility settings, is critical for understanding information gaps and service delivery needs in different settings. However, the existing methods for measuring out-of-facility abortion incidence are plagued with methodological challenges. Respondent-driven sampling (RDS) may offer a methodological improvement in the estimation of abortion incidence. OBJECTIVE: In this study, we tested the feasibility of using RDS to recruit participants into a study about abortion and estimated the proportion of people who ever attempted abortion as well as 1-year and 5-year incidence of abortion (both in-facility and out-of-facility settings) among women of reproductive age in Soweto, South Africa. METHODS: Participants were eligible if they identified as a woman; were aged between 15 and 49 years; spoke English, Tswana, isiZulu, Sotho, or Xhosa; and lived in Soweto. Working with community partners, we identified 11 seeds who were provided with coupons to refer eligible peers to the study. Upon arrival at the study site, the recruits completed an interviewer-administered questionnaire that solicited information about demographic characteristics, social network composition, health behaviors, sexual history, pregnancy history, and experience with abortion; recruits also received 3 recruitment coupons. Recruitment was tracked using coupon numbering. We used the RDS-II estimator to estimate the population proportions of demographic characteristics and our primary outcome, the proportion of people who ever attempted abortion. RESULTS: Between April 4, 2018, and December 17, 2018, 849 eligible participants were recruited into the study. The estimated proportion of people who ever attempted abortion was 12.1% (95% CI 9.7%-14.4%). A total of 7.1% (95% CI 5.4%-8.9%) reported a facility-based abortion, and 4.4% (95% CI 3.0%-5.8%) reported an out-of-facility abortion. CONCLUSIONS: The estimated proportion of people who ever attempted abortion of 12% (102/849) in our study likely represents a substantial underestimation of the actual proportion of abortion attempts among this study population-representing a failure of the RDS method to generate more reliable estimates of abortion incidence in our study. We caution against the use of RDS to measure the incidence of abortion because of persistent concerns with underreporting but consider potential alternative applications of RDS with respect to the study of abortion.

Effectiveness of self-managed medication abortion with accompaniment support in Argentina and Nigeria (SAFE): a prospective, observational cohort study and non-inferiority analysis with historical controls.

BACKGROUND: Clinical trials have established the high effectiveness and safety of medication abortion in clinical settings. However, barriers to clinical abortion care have shifted most medication abortion use to out-of-clinic settings, especially in the context of the COVID-19 pandemic. Given this shift, we aimed to estimate the effectiveness of self-managed medication abortion (medication abortion without clinical support), and to compare it to effectiveness of clinician-managed medication abortion. METHODS: For this prospective, observational cohort study, we recruited callers from two safe abortion accompaniment groups in Argentina and Nigeria who requested information on self-managed medication abortion. Before using one of two medication regimens (misoprostol alone or in combination with mifepristone), participants completed a baseline survey, and then two follow-up phone surveys at 1 week and 3 weeks after taking pills. The primary outcome was the proportion of participants reporting a complete abortion without surgical intervention. Legal restrictions precluded enrolment of a concurrent clinical control group; thus, a non-inferiority analysis compared abortion completion among those in our self-managed medication abortion cohort with abortion completion reported in historical clinical trials using the same medication regimens, restricted to participants with pregnancies of less than 9 weeks' gestation. This study was registered with ISCRTN, ISRCTN95769543. FINDINGS: Between July 31, 2019, and April 27, 2020, we enrolled 1051 participants. We analysed abortion outcomes for 961 participants, with an additional 47 participants reached after the study period. Most pregnancies were less than 12 weeks' duration. Participants in follow-up self-managed their abortions using misoprostol alone (593 participants) or the combined regimen of misoprostol plus mifepristone (356 participants). At last follow-up, 586 (99%) misoprostol alone users and 334 (94%) combined regimen users had a complete abortion without surgical intervention. For those with pregnancies of less than 9 weeks' gestation, both regimens were non-inferior to medication abortion effectiveness in clinical settings. INTERPRETATION: Findings from this prospective cohort study show that self-managed medication abortion with accompaniment group support is highly effective and, for those with pregnancies of less than 9 weeks' gestation, non-inferior to the effectiveness of clinician-managed medication abortion administered in a clinical setting. These findings support the use of remote self-managed models of early abortion care, as well as telemedicine, as is being considered in several countries because of the COVID-19 pandemic. FUNDING: David and Lucile Packard Foundation. TRANSLATIONS: For the Arabic, French, Bahasa Indonesian, Spanish and Yoruba translations of the Article see Supplementary Materials section.

Effectiveness of self-managed abortion during the COVID-19 pandemic: Results from a pooled analysis of two prospective, observational cohort studies in Nigeria.

Globally, restrictions imposed by the COVID-19 pandemic altered access to clinical abortion care, as well as people's ability to access abortion medications on their own. When clinical care is inaccessible, or when self-care is preferred, people use pills on their own, without clinical supervision, to end their pregnancies-a practice known as "self-managed" abortion. Little is known about experiences of self-managed abortion during the COVID-19 pandemic. The aim of this study was to measure experiences of self-managed abortion, including abortion completion, prior to and during the COVID-19 pandemic in Nigeria. Between October 2019-September 2020, we recruited callers to a safe abortion accompaniment group that provides information on self-managed abortion in Nigeria. Participants completed a baseline phone survey, and two follow-up phone surveys. Primary outcomes included burdens experienced prior to versus during the pandemic, and abortion completion. We calculated frequencies and percentages overall and by time period and compared outcomes across time periods using t-tests, Chi-squared tests, tests of proportion, and Mantel-Haenszel adjusted odds ratios. Overall, 807 participants were included in these analyses. Participants enrolled during the COVID-19 pandemic were more likely to report needing to borrow money (47.9% vs 29.4%) and find lodging outside the home (15.5% vs 3.2%) for their self-managed abortion than were those enrolled prior to the pandemic. Participants reported COVID-19 related difficulties most frequently during the earliest and strictest period of the lockdowns, particularly in obtaining and taking pills (32.4%), and comfort seeking healthcare (12.2%). Nearly all participants (95%) reported a complete abortion at last follow-up. Results from this study underscore the challenges Nigerians faced during the COVID-19 pandemic in self-managing their abortions, and also the essential role that a safe abortion hotline played in expanding access to safe abortion during a time when the formal healthcare system was less accessible and higher-risk.

Self-managed medication abortion outcomes: results from a prospective pilot study.

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.

Studying Accompaniment model Feasibility and Effectiveness (SAFE) Study: study protocol for a prospective observational cohort study of the effectiveness of self-managed medication abortion.

INTRODUCTION: A 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 ANALYSIS: This 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 DISSEMINATION: We 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 NUMBER: ISRCTN95769543.