Ipas, Chapel Hill, NC, USA.
Regional Institute for Population Studies (RIPS), University of Ghana, Accra, Ghana.
Contraception. 2024 Dec;140:110538. doi: 10.1016/j.contraception.2024.110538. Epub 2024 Jul 11.
To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic.
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).
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.
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.
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.
ClinicalTrials.gov (NCT03727308).
比较米非司酮和米索前列醇来源为药房或诊所的医疗流产后自我报告的临床结局。
我们在加纳的四个地区进行了一项前瞻性、非随机、非劣效性队列研究，涉及高容量的药房和诊所。招募了符合常规医疗流产资格标准、寻求医疗流产（小于 9 周妊娠）的参与者。数据收集包括基线调查、随访电话访谈和自我报告的医疗流产结局评估。该研究旨在招募 2000 名医疗流产使用者（每个来源 1000 名）。
从 2208 名入组者中获得了 1958 名（占 1958 名）完整结局数据，并进行了分析，调整后的需要额外治疗以完成流产的风险差异表明，与诊所组相比，药房组具有非劣效性[-2.3%（95%CI-5.3%至 0.7%）]。两组报告的额外治疗率均较低（4.9%），并且对流产方案的依从性相似。次要结局无显著差异，两组的可接受性均适中（药房组 65.4%，设施组 52.3%）。不良结局罕见：一例异位妊娠，一例输血，无死亡或其他重大并发症报告。
直接从药房获得医疗流产药而无需事先向提供者咨询，与从诊所寻求护理相比，自我报告的临床结局无差异。这一发现与越来越多的全球证据一致，这些证据支持医疗流产自我护理的安全性和有效性。
本研究提供的数据支持将医疗流产药物的非处方使用扩展至妊娠 9 周。这些措施可以扩大安全流产护理的选择范围，特别是在不安全流产对产妇健康构成重大风险的地区。
ClinicalTrials.gov（NCT03727308）。
