A Prospective, Comparative Study of Clinical Outcomes Following Clinic-Based Versus Self-Use of Medical Abortion

Abstract

Background: To determine whether clinical outcomes differ among women accessing a combined medical abortion regimen from a health clinic when compared with those accessing it from a pharmacy. Methods: We conducted a multicenter, prospective, comparative study of women aged ≥15 years seeking medical abortion from 5 clinics and 5 adjacent pharmacy-clusters in 3 provinces of Cambodia. Women were recruited in-person at the point of purchase (clinic or pharmacy). Follow-up for self-reported pill use, acceptability, and clinical outcomes occurred by telephone at day 10 and 30 after mifepristone administration. Findings: Over 10 months, we enrolled 2083 women with 1847 providing outcome data: 937 from clinics and 910 from pharmacies. Most were early in their pregnancy (mean gestational age of 6.3 and 6.1 weeks, respectively) and almost all took the pills correctly (98% and 96%; p=.126). Additional treatment needed to complete the abortion was non-inferior for the pharmacy group (9.3%) compared with the clinic group (12.7%). More women from the clinic group received additional care from a provider, such as antibiotics or diagnostics tests than those from the pharmacy group (11% and 2%; p=0.149), and one ectopic pregnancy (pharmacy group) was successfully treated. Most women said they felt prepared for what happened after taking the pills (91% and 81%, respectively; p=0.055). Interpretation: Self-use of a combined medical abortion product resulted in comparable clinical outcomes as use following a clinical visit. Registration and availability of medical abortion as an over-the-counter product would likely increase women’s access to safe abortion. Clinical Trial Registration Details: Registered with ClinicalTrials.gov (NCT03727308). Funding Information: Funding was provided by Ipas. Declaration of Interests: None to declare. Ethics Approval Statement: This study received ethical approval from the National Ethics Committee for Health Research in Cambodia.