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PRISM Trial Results: Does Progesterone for Bleeding Early in Pregnancy Prevent Pregnancy Loss?

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BACKGROUND AND PURPOSE:

  • Evidence is limited as to whether progesterone supplementation early in pregnancy may be beneficial to prevent miscarriage for those with bleeding in pregnancy
  • Coomarasamy et al. (NEJM, 2019), examined whether progesterone administered to women who are bleeding early in pregnancy results in a higher incidence of live birth ≥34 weeks

METHODS:

  • Multicenter, randomized, double-blind, placebo-controlled trial
  • Participants
    • 16 to 39 years of age
    • <12 weeks of pregnancy
    • Vaginal bleeding,
    • Gestational sac on ultrasound (intrauterine)
  • Randomized to
    • Progesterone arm: 400 mg vaginal suppositories twice a day from time of bleeding to 16 weeks
    • Control: Matching placebo
  • Primary outcome: Incidence of live-born ≥34 weeks
  • Multiple secondary outcomes including ongoing pregnancy beyond 12 weeks, miscarriage, live birth <34 weeks etc.
  • Statistical analysis
    • Power calculation: 90% power to detect a minimally important absolute difference of 5 percentage points between groups
    • 1,972 women required in each arm with plan to include 4150 to account for loss to follow-up

RESULTS:

  • 4,153 women | 48 UK hospitals
    • Progesterone: 2079 women | Placebo 2074 women
    • 97% of women available for analysis (primary outcome)
  • Incidence of live births ≥34 weeks was similar in the two groups (P=0.08)
    • Progesterone: 75%
    • Control: 72%
    • Relative rate 1.03 (95% CI, 1.00 to 1.07
    • When accounting for missing data, there was still no significant difference between groups
  • Secondary outcomes
    • Overall, there were no significant differences found for either maternal or fetal outcomes
    • The only finding was a small increase in ongoing pregnancy beyond 12 weeks (83% vs 80%; 95% CI, 1.04 (95% CI, 1.01 – 1.07)
  • Only one subgroup, women with ≥3 previous losses, showed a statistical difference for primary outcome (P=0.007)
    • Progesterone: 72%
    • Control: 57%
    • RR 1.28 (95% CI, 1.08 to 1.51)

CONCLUSION:

  • Progesterone therapy did not impact outcomes in women with bleeding early in pregnancy
  • Progesterone therapy for women with bleeding in pregnancy did not result in more live births ≥34 nor most clinically relevant secondary maternal or fetal outcomes
  • Authors caution that in the case of multiple miscarriages and subgroup analysis of pregnancy lasting beyond 12 weeks
    • Confirmation of results is required as there was no adjustment for multiple comparisons  

Learn More – Primary Sources:

A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy

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Related ObG Topics:

How Effective are Treatments for Unexplained Recurrent Miscarriage?
How Do Maternal Age and Pregnancy History Affect Risk of Miscarriage?
SMFM Statement: Choice of Progestogen for Preterm Birth Prevention

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