RESUMO
OBJECTIVES: To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic. STUDY DESIGN: We conducted a prospective, non-randomized, non-inferiority cohort study across four regions in Ghana, from high-volume pharmacies and health clinics. Participants seeking medical abortion (less than nine weeks' gestation) who met usual medical abortion eligibility criteria were recruited. Data collection included baseline surveys, follow-up phone interviews, and self-reported assessments of medical abortion outcomes. The study aimed to enroll 2000 medical abortion users (1000 from each source). RESULTS: Complete outcome data was available and analyzed from 1958 participants (of 2208 enrolled), with the adjusted risk difference of need for additional treatment to complete the abortion indicating non-inferiority of the pharmacy group compared to the clinic group [-2.3% (95% CI -5.3% to 0.7%)]. Both groups reported low rates of additional treatment (4.9%) and adhered similarly to the abortion regimen. Secondary outcomes showed no significant differences, with moderate acceptability in both groups (65.4% pharmacy, 52.3% facility). Adverse outcomes were rare: one ectopic pregnancy, one blood transfusion and no deaths or other major complications were reported. CONCLUSIONS: Accessing medical abortion pills directly from pharmacies without prior consultation from a provider demonstrated non-inferior self-reported clinical outcomes compared to seeking care from health clinics. The findings align with the growing global evidence supporting the safety and effectiveness of medical abortion self-care. IMPLICATIONS: This study contributes data which support future registration of over-the-counter use of medical abortion drugs up to nine weeks' gestation. Such measures could expand options for safe abortion care, especially in regions where unsafe abortion poses a substantial maternal health risk. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03727308).
RESUMO
Background: Despite progress in assuring provision of safe abortion, substantial disparities remain in quality of abortion care around the world. However, no consistent, valid, reliable method exists to routinely measure quality in abortion care across facility and out-of-facility settings, impeding learning and improvement. To address this need, the Abortion Service Quality Initiative developed the first global standard for measuring quality of abortion care in low-income and middle-income countries. Methods: This prospective cohort study was conducted in Bangladesh, Ethiopia, and Nigeria in 2020-2022. Participants included sites and providers offering abortion care, including health facilities, pharmacies, proprietary and patent medicine vendors (PPMVs), and hotlines, and clients aged 15-49 receiving abortion care from a selected site. 111 structure and process indicators were tested, which originated from a review of existing abortion quality indicators and from qualitative research to develop additional client-centred quality indicators. The indicators were tested against 12 clinical and client experience outcomes at the site-level (such as abortion-related deaths) and client-level (such as whether the client would recommend the service to a friend) that were expected to result from the abortion quality indicators. Indicators were selected for the final metric based on predictive validity assessed using Bayesian models to test associations between indicators and outcomes, content validity, and performance. Findings: We included 1915 abortion clients recruited from 131 sites offering abortion care across the three countries. Among the 111 indicators tested, 44 were associated with outcomes in Bayesian analyses and an additional 8 were recommended for inclusion by the study's Resource Group for face validity. These 52 indicators were evaluated on content validity, predictive validity, and performance, and 29 validated indicators were included in the final abortion care quality metric. The 29 validated indicators were feasibility tested among 53 clients and 24 providers from 9 facility sites in Ethiopia and 57 clients and 6 PPMVs from 9 PPMV sites in Nigeria. The median time required to complete each survey instrument indicated feasibility: 10 min to complete the client exit survey, 16 min to complete the provider survey, and 11 min to complete the site checklist. Overall, the indicators performed well. However, all providers in the feasibility test failed two indicators of provider knowledge to competently complete the abortion procedure, and these indicators were subsequently revised to improve performance. Interpretation: This study provides 29 validated abortion care quality indicators to assess quality in facility, pharmacy, and hotline settings in low-income and middle-income countries. Future research should validate the Abortion Care Quality (ACQ) Tool in additional abortion care settings, such as telemedicine, online medication abortion (MA) sellers, and traditional abortion providers, and in other geographical and legal settings. Funding: The David and Lucile Packard Foundation and the Children's Investment Fund Foundation.