A prospective randomized, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy

摘要

A prospective randomized, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy. Author: Dr Roopa Malik, Assistant Professor, Obstetrics and gynaecology department Pt BDS PGIMS Rohtak BACKGROUND: Vaginal misoprostol has been shown to be an effective single agent for medical agent for medical abortion. This randomized, placebo controlled trial compared a regimen of mefipristone and misoprostol with misoprostol alone for termination of early pregnancy. METHODS: 200 women with gestation <56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 ug vaginal misoprostol. Abortion success was defined as complete abortion without the use of surgical aspiration. RESULTS: Successful medical abortions occurred in 96 out of 100 subjects (96%) after mifepristone followed by vaginal misoprostol. In all, 79 out of 100 subjects (79%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (p < 0.05). CONCLUSION: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies <56 days than misoprostol alone. The misoprostol alone regimen for termination of early pregnancy is not a very good method for medical abortion but 79% efficacy obtained with vaginal misoprostol alone may clinically acceptable when mifepristone is not available.