ABSTRACT
Introduction: Mifepristone and misoprostol are the two drugs which are given at 36-48 h interval for medical abortion. This study was designed to study the efficacy of early administration of misoprostol (24 h after mifepristone) for medical termination of pregnancy less than 9 weeks and to compare this with standard protocol of mifepristone misoprostol combination at 48 h interval. Materials and Methods: Subjects for this single center prospective randomized case-control study were enrolled from the family planning outdoor patient department at our hospital with gestational age of less than 9 weeks. All subjects initially received 200 mg of oral mifepristone and then were randomly assigned to receive per vaginal 400 μg misoprostol at 24 h (study group) and 48 h (control group). They were then followed up after 14 days with transvaginal sonography to confirm completion of expulsion. Treatment was considered failed if surgical evacuation was needed for any indication. Primary outcome measure was success rate of the two treatment regimens. Results: Totally, 200 subjects were randomly allocated to each treatment arm (100 each). Complete expulsion was seen in 94% (94/100) in study group and 95% (95/100) in control group according to intention to treat analysis (P value ns). According to per protocol analysis success rate in study group was 93.6% and 94.3% in control group (P value ns). High failure rate after 7 weeks period of gestation in both the study and control group was found (26.3% and 30.0%; P value ns). Adverse effects were mostly similar in both the groups. Conclusion: Efficacy of mifepristone misoprostol combination at 24 h interval was similar to that at 48 h interval for medical abortion of pregnancy less than 9 weeks without compromising the safety (CTRI No. 2010/091/001422).