Comparison of Mifepristone Followed by Misoprostol with Misoprostol Alone for Treatment of Early Pregnancy Failure: A Randomized Double-Blind Placebo-Controlled Trial.

Abstract

To compare the efficacy and safety of mifepristone followed by misoprostol with misoprostol alone in the management of early pregnancy failure (EPF). A randomized double-blind placebo-controlled clinical trial. Ninety-two women with EPF ≤12weeks were recruited and randomly allocated to receive either mifepristone 200mg (n=46) or placebo (n=46). Forty-eight hours later, patients in both the groups were given 800µg misoprostol per-vaginum. If no expulsion occurred within 4h, repeat doses of 400µg misoprostol were given orally at 3-hourly interval to a maximum of 2 doses in women ≤9weeks by scan and 4 doses in women >9weeks by scan. Pre-treatment of misoprostol with mifepristone significantly increased the complete abortion rate (86.7 vs. 57.8%, p=0.009) and, hence, reduced the need for surgical evacuation (13.3 vs. 42.2%, p=0.002), induction to expulsion interval (4.74±2.24 vs. 8.03±2.77h, p=0.000), mean number of additional doses of misoprostol required (0.68 vs. 1.91, p=0.000), and side effects. Use of mifepristone prior to misoprostol in EPF significantly improves the efficacy and reduces the side effects of misoprostol alone.