Abstract
ObjectiveTo evaluate feasibility of self-assessment of medical abortion outcome using a low-sensitivity urine pregnancy test, checklist and text messages. The study assessed whether accurate self-assessment required a demonstration of the low-sensitivity urine pregnancy test or if verbal instructions suffice.MethodsThis non-inferiority trial enrolled 525 adult women from six public sector abortion clinics. Eligible women were undergoing medical abortion at gestations within 63 days. Consenting women completed a baseline interview, received standard care with mifepristone and home-administration of misoprostol. All were given a low-sensitivity urine pregnancy test and checklist for use 14 days later, sent text reminders, and asked to attend in-clinic follow-up after two weeks. Women were randomly assigned 1:1 to an instruction-only group (n = 262; issued with pre-scripted instructions on the low-sensitivity pregnancy test), or a demonstration group (n = 263; performed practice tests guided by lay health workers). The primary outcome was accurate self-assessment of incomplete abortion, defined as needing additional misoprostol or vacuum aspiration. Analysis was by intention to treat and a non-inferiority margin was set to six percentage points. Women’s acceptability of their abortion procedure and preferences for follow-up were also assessed.ResultsFollow-up was 81% for abortion outcome, confirmed in-clinic at two weeks or self-reported within six months. Non-inferiority of instruction-only to a demonstration was inconclusive for accurate self-assessment (risk difference for instruction-only –demonstration: -2.5%; 95%CI: -9% to 4%). Comparing instruction-only to demonstration groups, 99% and 100% found the pregnancy test easy to do; and 91% and 93% respectively chose the pregnancy test, checklist and text messages for abortion outcome assessment in the future.ConclusionRoutine self-assessment using a low-sensitivity pregnancy test, checklist and text messages is feasible and preferred by women attending South African primary care abortion clinics. Counselling with additional emphasis on prompt recognition of ongoing pregnancies is recommended.Trial registrationClinicalTrials.gov NCT02231619
Highlights
Medical abortion with mifepristone and misoprostol was introduced into public sector primary care services in South Africa in 2010 [1]
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
The World Health Organization (WHO) technical guidelines stated that routine in-clinic assessment is not required, if given adequate counselling on signs of ongoing pregnancy and complications [8]
Summary
Medical abortion with mifepristone and misoprostol was introduced into public sector primary care services in South Africa in 2010 [1]. The multi-level test, while highly accurate, involves comparing serial hCG measurements performed at baseline and repeated 7–14 days later [17] As such, both complexity of the test and cost could be a barrier in resource-constrained settings in developing countries. For the South African primary healthcare sector, a single, simple, lowsensitivity urine pregnancy test (LSUPT) for home-use, together with a checklist, might be a more feasible tool for self-assessment of medical abortion outcome. This could be supplemented by automated text message reminders to women over the course of the abortion process, providing an effective, low-cost support mechanism [19]. It was unknown if this package would be preferred to in-clinic follow-up by women, and if lack of privacy at home would present a barrier to this approach
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