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

Roopa Malik, Viral Kumar, Vijayata Sangwan, Smiti Nanda

Post Graduate Institute of Medical Science, Rohtak, India.

DOI: 10.4236/ojog.2012.21016                

Abstract

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.

Keywords

Abortion; Medical Abortion; Mifepristone; Misoprostol; Pregnancy

Conflicts of Interest

The authors declare no conflicts of interest.

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