A prospective, comparative study of clinical outcomes following clinic-based versus self-use of medical abortion

Abstract

BackgroundTo 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.MethodsWe 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.ResultsOver 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).ConclusionsSelf-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.

Developing and validating an abortion care quality metric for facility and out-of-facility settings: an observational cohort study in Bangladesh, Ethiopia, and Nigeria

“…All client-level outcomes, including clinical abortion outcomes, were measured based on client self-report rather than provider report or medical record review. Use of client-reported clinical abortion outcomes is in alignment with similar studies, 27 , 28 but this approach may introduce bias, particularly if some subgroups of abortion clients are more likely to report certain outcomes. This study used a rigorous approach to validating the final abortion quality metric, but also sought to be stakeholder-centred to ensure uptake and use of the final abortion quality metric, which meant that individuals participating the ASQ Resource Group had an influence on the final metric.…”

Can mid‐level providers manage medical abortion after 12 weeks' gestation as safely and effectively as physicians? A non‐inferiority, randomized controlled trial in Addis Ababa, Ethiopia

“…We required 88 participants to determine non‐inferiority of the mid‐level provider group, with a one‐sided margin of −1.5 h, assuming 80% power ( β = 0.2), and a one‐sided confidence level of 97.5% ( α = 0.025). We anticipated post‐randomization clustering at the provider level; thus, we increased the sample size to a total of 111 patients by including an intraclass correlation ( ρ ) of 0.026 at the provider level based on previous studies 26 and an average cluster size ( m ) of 11 patients. With rounding, the final sample size was 120, assuming an average of 10 clients recruited from 12 providers (six physicians and six mid‐level providers).…”

“…[20][21][22][23][24] We required 88 participants to determine non-inferiority of the mid-level provider group, with a one-sided margin of −1.5 h, assuming 80% power (β = 0.2), and a one-sided confidence level of 97.5% (α = 0.025). We anticipated post-randomization clustering at the provider level; thus, we increased the sample size to a total of 111 patients by including an intraclass correlation (ρ) of 0.026 at the provider level based on previous studies 26 We assessed non-inferiority of the mid-level compared with the physician group in terms of median time to fetal expulsion using unadjusted and adjusted regression models. 27 The mid-level provider group would be considered non-inferior to the physician group if the one-sided confidence interval (CI) for the difference in median time to expulsion was within the predetermined non-inferiority margin of −1.5 h after accounting for provider-level clustering.…”

Client-reported quality of facility-managed medication abortion compared with pharmacy-sourced self-managed abortion in Bangladesh

“…Self-managed medication abortion (SMA), where an individual terminates their pregnancy with medications without formal clinical management, has been shown to be safe and effective, has been incorporated into global care standards, and has the potential to expand abortion access and improve health outcomes 1–4. SMA exists on a continuum from minimal or no interaction with health systems, as in accompaniment models, hotlines, and independent drug shops, to some or more health system interaction, as in direct pharmacy-based care 5 6.…”