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

Abstract

Objective: To determine whether clinical outcomes among clients undergoing medical abortion after 12 weeks' gestation differ by provider cadre. Methods: Randomized 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. Results: After 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. Conclusions: Training mid-level providers to provide abortion services after 12 weeks' gestation independently of physicians is feasible and may result in comparable clinical outcomes.