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Grand Rounds

Triple M RCT Results: Mifepristone Plus Misoprostol for the Management of Early Pregnancy Loss

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BACKGROUND AND PURPOSE:

  • Hamel et al. (EClinicalMed, 2021) report on the results of the Triple M Trial, comparing the sequential combination of mifepristone with misoprostol vs misoprostol alone for the treatment of early pregnancy loss

METHODS:

  • Multi-center, double-blind, placebo-controlled randomized trial
  • Participants
    • Women with a non-viable pregnancy
    • Between 6 and 14 weeks
    • ≥1 week expectant management
  • Interventions
    • Mifeprestone + misoprostol
      • 600 mg oral mifepristone and 400 μg oral misoprostol | Repeated after four hours on day two and, if necessary, day three
    • Placebo + misoprostol
  • Study design
    • Participants were randomized 1:1
    • Analysis was by intention-to-treat
  • Primary outcome
    • Ultrasound at 6 to 8 weeks: Expulsion of gestational sac and endometrial thickness <15 mm

RESULTS:

  • Placebo: 172 women | Mifepristone: 172 women
  • More women in the mifepristone group reached complete evacuation
    • Mifepristone: 79.1%
    • Placebo: 58.7%
    • RR 1.35 (95% CI, 1.16 to 1.56; p<0.0001)
  • Fewer adverse events occurred in the mifepristone group (p=0.0005)
    • Mifepristone: 14%
    • Placebo: 32%
  • Number needed to treat: 4.9
  • Triple M Trial study was “halted prematurely because the highly significant results of the pre-planned interim analysis met the pre-defined stopping rule”

CONCLUSION:

  • For the medical management early pregnancy loss, mifepristone followed by misoprostol resulted in a significantly higher number of patients with complete evacuation of the uterus
    • In addition, there were fewer adverse events using this approach  
  • The authors conclude

The implementation of this proven safe regimen into (inter)national guidelines may lead to an extensive improvement in the medical treatment of EPL worldwide

Learn More – Primary Sources:

Mifepristone followed by misoprostol compared with placebo followed by misoprostol as medical treatment for early pregnancy loss (the Triple M trial): A double-blind placebo-controlled randomised trial

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Related ObG Topics:

MifeMiso RCT results: Mifepristone Plus Misoprostol or Misoprostol Alone for Miscarriage Treatment?
Does Adding Mifepristone Prior to Misoprostol Improve Medical Management of Pregnancy Loss?
Is Misoprostol Management Effective for Management of Stillbirth?

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