To evaluate the effectiveness of mifepristone pretreatment with misoprostol alone for termination of pregnancy following the fetal demise in the second trimester was the study’s aim.
This prospective, double-blind, placebo-controlled trial randomly assigned women between 14 and 28 weeks of gestation who needed a pregnancy termination due to fetal death to either a placebo or 200 mg mifepristone orally 24–48 hours before the misoprostol-assisted abortion (400 micrograms every 6 hours vaginally for women at 24 weeks of gestation or less, and 200 micrograms every 4 hours vaginally for women at 24 weeks of gestation or more). A sample size of 116 women per group was designed to compare the primary outcome of time from misoprostol administration to delivery, based on median labor with misoprostol alone in the second trimester of 13 hours. The experiment was halted after 66 women were enrolled as a result of the lengthy period required to recruit them.
Between April 2013 and November 2016, 66 women were randomly assigned (34 to placebo and 32 to mifepristone). There were no variations in the two groups’ features. In the placebo group, the median time from misoprostol administration to delivery was 10.5 hours, compared to 6.8 hours in the treatment group (hazard ratio 2.41, 95 percent CI 1.39–4.17, P=.002). The placebo group required higher misoprostol doses (3.4 vs 2.1, P=.002) and more misoprostol overall (1,181.8 micrograms vs 767.7 micrograms, P=.003). In terms of maternal problems, there was no difference between the two groups. Women in the mifepristone group had a more positive attitude about the operation. When compared to misoprostol alone, the sequential administration of mifepristone and misoprostol for the termination of pregnancy following fetal deaths between 14 and 28 weeks of gestation lowers the time to delivery while having no adverse effects on maternal problems.
