Abstract：
OBJECTIVE: To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov (NCT03727308).
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov (NCT03727308).
摘要：
目的：比较药物流产后米非司酮和米索前列醇的自我报告的临床结果。
方法：我们进行了前瞻性，非随机化，加纳四个地区的非劣效性队列研究，来自大量药房和健康诊所。招募符合常规药物流产资格标准的寻求药物流产（妊娠少于9周）的参与者。数据收集包括基线调查，后续电话采访,和自我报告的药物流产结果评估。该研究旨在招募2,000名医疗流产用户（每个来源1,000名）。
结果：从1,958名参与者（2208名参与者）获得并分析了完整的结果数据。调整后的需要额外治疗以完成流产的风险差异表明,与临床组相比,药物组非劣性[-2.3%(95%CI-5.3%~0.7%)].两组报告的额外治疗率低（4.9％），并坚持类似的流产方案。次要结果没有显着差异，在两组中具有中等可接受性(65.4%的药房，52.3%设施）。不良结局很少见：一次异位妊娠，1次输血,无死亡或其他重大并发症报告.
结论：与从健康诊所寻求护理相比，在未经提供者事先咨询的情况下直接从药房获得药物流产药丸的自我报告的临床结果不差。这些发现与越来越多的全球证据一致，支持药物流产自我护理的安全性和有效性。
结论：这项研究提供了数据，支持未来在妊娠9周之前非处方药的使用。这些措施可以扩大安全堕胎护理的选择，特别是在不安全人工流产对孕产妇健康构成重大风险的地区。
背景：ClinicalTrials.gov（NCT03727308）。
方法：我们进行了前瞻性，非随机化，加纳四个地区的非劣效性队列研究，来自大量药房和健康诊所。招募符合常规药物流产资格标准的寻求药物流产（妊娠少于9周）的参与者。数据收集包括基线调查，后续电话采访,和自我报告的药物流产结果评估。该研究旨在招募2,000名医疗流产用户（每个来源1,000名）。
结果：从1,958名参与者（2208名参与者）获得并分析了完整的结果数据。调整后的需要额外治疗以完成流产的风险差异表明,与临床组相比,药物组非劣性[-2.3%(95%CI-5.3%~0.7%)].两组报告的额外治疗率低（4.9％），并坚持类似的流产方案。次要结果没有显着差异，在两组中具有中等可接受性(65.4%的药房，52.3%设施）。不良结局很少见：一次异位妊娠，1次输血,无死亡或其他重大并发症报告.
结论：与从健康诊所寻求护理相比，在未经提供者事先咨询的情况下直接从药房获得药物流产药丸的自我报告的临床结果不差。这些发现与越来越多的全球证据一致，支持药物流产自我护理的安全性和有效性。
结论：这项研究提供了数据，支持未来在妊娠9周之前非处方药的使用。这些措施可以扩大安全堕胎护理的选择，特别是在不安全人工流产对孕产妇健康构成重大风险的地区。
背景：ClinicalTrials.gov（NCT03727308）。
