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.

摘要

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 microg of misoprostol vaginally, with up to three additional oral doses of 400 microg misoprostol every 12 h. Group 2 (EL) received an intra-amniotic injection of 100mg 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.