Accounting for Misclassification and Selection Bias in Estimating Effectiveness of Self-managed Medication Abortion.

BACKGROUND: Studies on the effectiveness of self-managed medication abortion may suffer from misclassification and selection bias due to self-reported outcomes and loss of follow-up. Monte Carlo sensitivity analysis can estimate self-managed abortion effectiveness accounting for these potential biases. METHODS: We conducted a Monte Carlo sensitivity analysis based on data from the Studying Accompaniment model Feasibility and Effectiveness Study (the SAFE Study), to generate bias-adjusted estimates of the effectiveness of self-managed abortion with accompaniment group support. Between July 2019 and April 2020, we enrolled a total of 1051 callers who contacted accompaniment groups in Argentina and Nigeria for self-managed abortion information; 961 took abortion medications and completed at least one follow-up. Using these data, we calculated measures of effectiveness adjusted for ineligibility, misclassification, and selection bias across 50,000 simulations with bias parameters drawn from pre-specified Beta distributions in R. RESULTS: After accounting for the potential influence of various sources of bias, bias-adjusted estimates of effectiveness were similar to observed estimates, conditional on chosen bias parameters: 92.68% (95% simulation interval: 87.80%, 95.74%) for mifepristone in combination with misoprostol (versus 93.7% in the observed data) and 98.47% (95% simulation interval: 96.79%, 99.39%) for misoprostol alone (versus 99.3% in the observed data). CONCLUSIONS: After adjustment for multiple potential sources of bias, estimates of self-managed medication abortion effectiveness remain high. Monte Carlo sensitivity analysis may be useful in studies measuring an epidemiologic proportion (i.e., effectiveness, prevalence, cumulative incidence) while accounting for possible selection or misclassification bias.

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.

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.

Medication Abortion Safety and Effectiveness With Misoprostol Alone.

Importance: Misoprostol-alone regimens for abortion may be more effective than previously thought. Objective: To estimate the effectiveness of medication abortion with misoprostol alone among individuals self-managing their abortion. Design, Setting, and Participants: For this prospective observational cohort study of callers to safe abortion hotlines and accompaniment groups in Argentina, Nigeria, and Southeast Asia, participants were recruited between July 31, 2019, and October 1, 2020, prior to starting their medication abortion. Eligible participants were 13 years or older, had no contraindications to medication abortion, and were not currently bleeding. Participants completed a baseline and 2 follow-up surveys. The analysis was restricted to participants who reported using misoprostol alone and was performed between January 6, 2022 and September 8, 2023. Exposure: Self-managed medication abortion using misoprostol alone. Main Outcomes and Measures: The primary outcome was effectiveness, defined as participant self-report of complete abortion without procedural intervention, measured at 1 week and 3 weeks after taking misoprostol. Secondary outcomes included method safety, measured by self-report of experiencing warning signs (eg, heavy bleeding, pain, fever, discharge) indicative of a potential complication and by medical treatment (eg, blood transfusion, intravenous fluids, overnight hospital stay) indicative of a potential adverse event. Additional outcomes included length of bleeding and cramping, time to expulsion, and experience of adverse effects. Results: Among 1352 enrolled participants, 637 used misoprostol-alone regimens for abortion and were included in the analysis (591 [92.8%] from Nigeria, 45 [7.1%] from Southeast Asia, and 1 [0.2%] from Argentina; 384 [60.2%] aged 20-29 years; 317 [49.8%] with pregnancy durations <7 weeks and 205 [32.2%] with pregnancy durations between 7 and <9 weeks). At last follow-up after taking medication (median, 22 days; IQR, 21-26 days), 625 participants (98.1%; 95% CI, 96.7%-98.9%) had a complete abortion without procedural intervention. Potential adverse events were reported by 6 participants (0.9%; 95% CI, 0.4%-2.1%). Most participants experienced bleeding for less than 1 week (median, 4 days; IQR, 3-6 days) and expelled their pregnancy within 24 hours of starting the abortion process (median, 12 hours; IQR, 9-15 hours). Common side effects included nausea (335 participants [52.6%]), fever (232 [36.4%]), and diarrhea (181 [28.4%]). Conclusions and Relevance: The findings suggest that misoprostol alone is a highly effective method of pregnancy termination. Future research should explore strategies to maximize the effectiveness of misoprostol alone in clinical and nonclinical settings.

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 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.

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.

A qualitative exploration of how the COVID-19 pandemic shaped experiences of self-managed medication abortion with accompaniment group support in Argentina, Indonesia, Nigeria, and Venezuela.

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.

Effect of a smartphone intervention on self-managed medication abortion experiences among safe-abortion hotline clients in Indonesia: A randomized controlled trial.

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.

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.