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

ObjectiveTo determine whether clinical outcomes among clients undergoing medical abortion after 12 weeks' gestation differ by provider cadre.MethodsRandomized controlled trial conducted among eligible clients seeking abortion between 13 and 20 weeks' gestation. Participants seeking in-facility abortion were randomized to receive care from a mid-level provider (nurse/midwife) or physician. The primary outcome was median time to expulsion with non-inferiority margin of -1.5 h between provider groups. Quantile median regression models assessed non-inferiority. Secondary outcomes included retained placenta, complications, and patient acceptability.ResultsAfter randomization and eligibility assessment by the provider, 171 women participated in the study: 81 in the physician group and 90 in the mid-level provider group. Their average age was 24 years, the mean gestational age was 16 weeks, and 65% were nulliparous in both groups. The median time to expulsion did not differ significantly, being 8.1 h for the mid-level group and 6.6 h for the physician group. The adjusted median difference was 0.8 h (95% confidence interval [CI] -1.15 to 2.66), within the non-inferiority margin. Retained placenta occurred similarly: 30.0% (n = 24) of the physician group and 20.5% (n = 18) of the mid-level provider group (adjusted risk difference [ARD] 7.6%, 95% CI -2.81 to 18.06). Complications occurred in 7% of cases, including 5.0% (n = 4) of patients in the physician group and 8.9% (n = 8) in the mid-level provider group (ARD -4.7%, 95% CI -12.43 to 3.12). Patient acceptability did not differ by group.ConclusionsTraining mid-level providers to provide abortion services after 12 weeks' gestation independently of physicians is feasible and may result in comparable clinical outcomes. Training mid-level providers in abortion service provision after 12 weeks' gestation is feasible and results in comparable patient clinical outcomes to those achieved by physician-led care.