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

METHODS:

• Prospective, double blind, randomized, placebo-controlled trial
• Participants
  • Termination for fetal death
  • Between 14 and 28 weeks of gestation
• Interventions
  • 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
• Study design
  • 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
• Primary outcome
  • Time from administration of misoprostol to delivery

RESULTS:

• 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

CONCLUSION:

• 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

Learn More – Primary Sources:

Pretreatment With Mifepristone Compared With Misoprostol Alone for Delivery After Fetal Death Between 14 and 28 Weeks of Gestation: A Randomized Controlled Trial

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MifeMiso RCT results: Mifepristone Plus Misoprostol or Misoprostol Alone for Miscarriage Treatment?

Does Adding Mifepristone Prior to Misoprostol Improve Medical Management of Pregnancy Loss?

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