Mifepristone combined with misoprostol versus intra-amniotic injection of ethacridine lactate for the termination of second trimester pregnancy: a prospective, open-label, randomized clinical trial

Abstract

Objectives To compare the effectiveness and safety of mifepristone/misoprostol versus intra-amniotic injection of ethacridine lactate for the termination of second trimester pregnancy. Study design 210 women requesting voluntary termination of pregnancies at between 16 and 24 weeks of gestation were randomly assigned into two groups. Group 1 (MM) received a single oral dose of 200 mg mifepristone and, 36–48 h later, 400 μg of misoprostol vaginally, with up to three additional oral doses of 400 μg misoprostol every 12 h. Group 2 (EL) received an intra-amniotic injection of 100 mg ethacridine lactate. The primary outcome was successful abortion rate. Secondary outcomes included the difference in the induction-to-abortion interval and the frequency of adverse events. Results Both MM and EL regimens were effective, with successful abortion rates of 96.19% and 94.29%, respectively ( P = 0.746). The complete abortion rates were 68.57% and 70.48%, respectively. The induction-to-abortion interval was longer in the MM group than in the EL group (50.57 ± 6.80 h vs. 43.02 ± 8.74 h, respectively, P < 0.001). Both treatments were safe, although there was a significant difference in rates of gastrointestinal and fever adverse events between the two groups. Conclusions Both MM and EL regimens were effective with high success rates and were safe for the termination of second trimester pregnancy.