Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial

Abstract

Objective: To 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.

Methods: This 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.

Results: Follow-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.

Conclusion: Routine 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 registration: ClinicalTrials.gov NCT02231619.

Fig 1. Trial profile.

(A)Women returned to the clinic, but the provider was not present. In final FU phone contact abortion outcome was self-reported. (B)Women returned to the clinic, but the provider was not present. Final FU phone contact was unsuccessful and abortion outcome could not be confirmed. (C)Women did not return to the clinic, FU at 14 days was by phone. Final FU phone contact was unsuccessful and abortion outcome could not be confirmed.

Fig 2. Observed difference (95% CI) between study groups for accurate self-assessment.