Medical abortion in Ghana: A non-randomized, non-inferiority study of access through pharmacies compared with clinics

IF 2.3 2区医学 Q1 OBSTETRICS & GYNECOLOGY Contraception Pub Date : 2024-12-01 Epub Date: 2024-07-11 DOI:10.1016/j.contraception.2024.110538

Nathalie Kapp , Ayaga A. Bawah , Caesar Agula , Jamie L. Menzel , Samuel K. Antobam , Patrick O. Asuming , Elisabeth Eckersberger , Erin E. Pearson

{"title":"Medical abortion in Ghana: A non-randomized, non-inferiority study of access through pharmacies compared with clinics","authors":"Nathalie Kapp , Ayaga A. Bawah , Caesar Agula , Jamie L. Menzel , Samuel K. Antobam , Patrick O. Asuming , Elisabeth Eckersberger , Erin E. Pearson","doi":"10.1016/j.contraception.2024.110538","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><div>To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic.</div></div><div><h3>Study design</h3><div>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).</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div><div><h3>Implications</h3><div>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.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT03727308).</div></div>","PeriodicalId":10762,"journal":{"name":"Contraception","volume":"140 ","pages":"Article 110538"},"PeriodicalIF":2.3000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contraception","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0010782424002270","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/11 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

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).

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

加纳的医疗堕胎：通过药店与诊所进行堕胎的非随机、非劣效研究。

目的：比较使用米非司酮和米索前列醇进行药物流产后的自我报告临床结果：比较在药房或诊所使用米非司酮和米索前列醇进行药物流产后自我报告的临床结果：研究设计：我们在加纳的四个地区开展了一项前瞻性、非随机、非劣效性队列研究，研究对象来自药店和诊所。我们招募了寻求药物流产（妊娠不足九周）且符合常规药物流产资格标准的参与者。数据收集包括基线调查、后续电话访谈以及医疗流产结果的自我报告评估。研究的目标是招募 2,000 名药物流产使用者（每个来源各 1,000 名）：药房组与诊所组相比，需要额外治疗以完成流产的调整后风险差异为-2.3%（95% CI -5.3%至0.7%）]。两组报告的额外治疗率均较低（4.9%），对人工流产方案的坚持程度相似。次要结果显示无明显差异，两组的接受度均处于中等水平（药房为 65.4%，诊所为 52.3%）。不良结果很少见：一次宫外孕、一次输血，没有死亡或其他重大并发症的报告：结论：直接从药店购买药物流产药片，无需事先咨询医疗服务提供者，其自我报告的临床结果并不优于从医疗诊所寻求治疗。研究结果与全球越来越多的证据一致，支持药物流产自我护理的安全性和有效性：本研究提供的数据支持未来对妊娠九周以内的非处方使用药物流产进行登记。此类措施可扩大安全堕胎护理的选择范围，尤其是在不安全堕胎对孕产妇健康构成重大风险的地区：试验注册：ClinicalTrials.gov (NCT03727308)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Contraception 医学-妇产科学

CiteScore

4.70

自引率

17.20%

发文量

211

审稿时长

69 days

期刊介绍： Contraception has an open access mirror journal Contraception: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review. The journal Contraception wishes to advance reproductive health through the rapid publication of the best and most interesting new scholarship regarding contraception and related fields such as abortion. The journal welcomes manuscripts from investigators working in the laboratory, clinical and social sciences, as well as public health and health professions education.