Role of combination of mifepristone and misoprostol versus misoprostol alone in induction of labor in late intrauterine fetal death: A randomized trial

Objectives: To compare the efficacy, safety of a combination of mifepristone and misoprostol with oral misoprostol alone for induction of labor in late IUFD cases.Methods: A hospital based prospective randomized comparative study over 120 pregnant women with IUFD after 28 weeks of gestation requiring induction of labor for termination of pregnancy. Women were divided into two groups. Women of group1(n=63) received a single oral dose of 200 mg of mifepristone, and after 24 hours, 50 mcg of intravaginal misoprostol was administered followed by 50 mcg of intravaginal misoprostol at 6 hours interval for a maximum of 5 doses if required. For group 2 (misoprostol alone group, n=57) received only misoprostol in the dose of 50 mcg intravaginally every 6 hours for a maximum of 5 doses (5x50 mcg=250 mcg in 24hours).Primary outcome was measured by the rate of successful delivery in 24 hours and induction delivery interval from first dose of misoprostol to complete delivery of fetus and placenta.Results: Successful delivery occurred within 24 hours, who received mifepristone before misoprostol than misoprostol alone (94% versus 81%; difference12.95%; 95% CI, 1.07%-24.83%). Mean induction delivery interval in combined regime (group 1) and misoprostol only regime(group 2) was 12.45h (95% CI of mean, 10.863h-14.038h) and 20.25h (95% CI of mean,18.284h-22.216h) respectively; P=0.0001. Mean dose of misoprostol required in group 1 was 2.41± 1.19 and 3.67± 1.07 in group 2 (P=0.0001).With respect to side effects, the two groups did not differ significantly.Conclusions: Addition of mifepristone to misoprostol appears to be more effective than misoprostol alone for induction of labor in late IUFD cases but both the regimens were equally safe, easy to administer and affordable.