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

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.

Highlights

Termination of pregnancy is a medically directed miscarriage prior to independent viability, using pharmacological or surgical means
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
Successful medical abortions occurred in 96 out of 100 subjects (96%) after mifepristone followed by vaginal misoprostol

Summary

INTRODUCTION

Termination of pregnancy is a medically directed miscarriage prior to independent viability, using pharmacological or surgical means. A regimen of 600 mg of mifepristone followed by 400 ug oral misoprostol was approved for use in USA in September 2000 for elective termination of pregnancy up to 49 days gestation [3]. Studies have been ongoing to develop alternative regimens with these agents that are easier to administer, are cost effective, have low incidence of side effects and improve acceptability of the method. It is easier to use, provide more rapid pregnancy termination and is less expensive compared with the mifepristone and misoprostol combination regimen. It can be used in areas where mifepristone is unavailable or is difficult to obtain. This study was designed to compare mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy

MATERIAL AND METHODS

OBSERVATIONS

Findings

DISCUSSION