RCT Results: Does Mifepristone Pretreatment for Termination of Pregnancy After Fetal Loss Improve Time to Delivery?
BACKGROUND AND PURPOSE:
Allanson et al. (Obstetrics & Gynecology, 2021) assessed the efficacy of pretreatment with mifepristone before misoprostol, compared with misoprostol alone, for termination of pregnancy after a fetal death in the second trimester
200 mg mifepristone orally 24 to 48 hours before the termination of pregnancy with misoprostol
14 to 24 weeks: 400 micrograms every 6 hours vaginally
24 to 28 week: 200 micrograms every 4 hours vaginally
Placebo before misoprostol
A sample size of 116 women per group was planned
Trial was ceased after 66 women enrolled secondary to prolonged time to achieve recruitment | Over time of the study, resources were available at other centers and recruitment site was no longer receiving as many patients for this procedure
Time from administration of misoprostol to delivery
34 women received placebo | 32 received mifepristone
There were no differences in the characteristics between the groups
The median time to delivery was significantly reduced in the mifepristone group
Mifepristone + misoprostol: 6.8 hours
Placebo + misoprostol: 10.5 hours
Hazard ratio 2.41 (95% CI, 1.39 to 4.17); P = 0.002
Women in the placebo group also required
More doses of misoprostol (P = 0.002)
Mifepristone + misoprostol: 2.1 doses
Placebo + misoprostol: 3.4 doses
More misoprostol overall (P = 0.003)
Mifepristone + misoprostol: 767.7 micrograms
Placebo + misoprostol: 1,181.8 micrograms
There was no difference in maternal complications between the two groups
Women in the mifepristone group reported improved perception of the procedure
Compared to misoprostol alone, the use of mifepristone prior to misoprostol for termination of pregnancy after fetal death between 14 and 28 weeks significantly reduced the time to delivery and the amount of misoprostol needed
The authors conclude
Despite the early termination of our trial, we achieved our planned outcome of a 30% reduction in the median duration of labor
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
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