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 multicentre, prospective, comparative, non-inferiority study of participants aged ≥15 years seeking medical abortion from five clinics and five adjacent pharmacy clusters in three provinces of Cambodia. Participants 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 days 10 and 30 after mifepristone administration.

Results: 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%,). Additional treatment needed to complete the abortion was non-inferior for the pharmacy group (9.3%) compared with the clinic group (12.7%). More from the clinic group received additional care from a provider, such as antibiotics or diagnostics tests, than those from the pharmacy group (11.5% and 3.2%,), and one ectopic pregnancy (pharmacy group) was successfully treated. Most said they felt prepared for what happened after taking the pills (90.9% and 81.3%, respectively, p=0.273).

Conclusions: Self-use of a combined medical abortion product resulted in comparable clinical outcomes as use following a clinical visit, consistent with existing literature on its safety and efficacy. Registration and availability of medical abortion as an over-the-counter product would likely increase women's access to safe abortion.