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Grand Rounds

2021 Cochrane Review: Do Progestogens Increase Live Births for Those with Threatened or Recurrent Miscarriage?

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BACKGROUND AND PURPOSE:

  • Devall et al. (Cochrane Reviews, 2021) assessed the relative effectiveness and safety profiles for different progestogen treatments for threatened and recurrent miscarriage

METHODS:

  • Systematic review and meta-analysis
  • Study inclusion criteria
    • Randomized and cluster-randomized controlled trials
    • Studies that assessed the effectiveness or safety of progestogen treatment for the prevention of miscarriage
  • Study design
    • The relative effects for the primary and secondary outcomes were estimated
    • Relative effects were reported by the type of miscarriage
      • Threatened: Bleeding in early pregnancy
      • Recurrent: ≥3 losses
    • GRADE criteria were used to assess the certainty of evidence
  • Primary outcome
    • Live birth
  • Secondary outcomes
    • Miscarriage (< 24 weeks of gestation)
    • Preterm birth (< 37 weeks of gestation)
    • Stillbirth
    • Ectopic pregnancy
    • Congenital abnormalities
    • Adverse drug events

RESULTS:

  • 7 randomized trials (total 14 treatment arms) | 5682 women
    • Vaginal micronized progesterone: 21% (3 treatment arms)
    • Dydrogesterone: 21% (3 arms)
    • Oral micronized progesterone: 7% (1 arm)
    • 17-α-hydroxyprogesterone: 7% (1 arm)
    • Placebo: 43% (6 arms)

Women with Threatened Miscarriage

  • Compared to placebo, vaginal micronized progesterone and dydrogesterone probably make little or no difference to the live birth rate
    • Vaginal micronized progesterone
      • Relative risk (RR) 1.03 (95% CI, 1.00 to 1.07)
      • 2 trials; 4090 women; high-certainty evidence
    • Dydrogesterone
      • RR 0.98 (95% CI, 0.89 to 1.07)
      • 1 trial; 406 women; moderate-certainty evidence
    • There were no data to assess the effectiveness of 17-α-hydroxyprogesterone on live birth

Subgroup Analysis: Previous Miscarriages

  • No previous miscarriages and early pregnancy bleeding
    • Probably little or no improvement in the live birth rate with vaginal micronized progesterone
    • RR 0.99 (95% CI, 0.95 to 1.04); high-certainty evidence
  • Subgroup analysis: ≥1 previous miscarriages and early pregnancy bleeding
    • Vaginal micronized progesterone increases the live birth rate
    • RR 1.08 (95% CI, 1.02 to 1.15); high-certainty evidence

Women with Recurrent Miscarriage

  • Vaginal micronized progesterone probably makes little or no difference to the live birth rate vs placebo
    • RR 1.04 (95% CI, 0.95 to 1.15); high-certainty evidence
  • The effects of dydrogesterone are unclear due to very low-certainty evidence
  • No data available to assess the effectiveness of 17-α-hydroxyprogesterone or oral micronized progesterone on live birth

Other Outcomes: Adverse Events and Congenital Anomalies

  • There is probably no difference in other outcomes for vaginal micronized progesterone vs placebo (data limited for other progestogens)
    • Threatened miscarriage
      • Congenital abnormalities
        • RR 1.00 (95% CI, 0.68 to 1.46)
        • Moderate-certainty evidence
      • Adverse drug events
        • RR 1.07 (95% CI, 0.81 to 1.39)
        • Moderate-certainty evidence
    • Recurrent miscarriage
      • Congenital abnormalities
        • RR 0.75 (95% CI, 0.31 to 1.85)
        • Low-certainty evidence
      • Adverse drug events
        • RR 1.46 (95% CI 0.93 to 2.29)
        • Moderate-certainty evidence

Note: Data limited and very low‐certainty evidence on congenital abnormalities and adverse drug events for the other progestogens

CONCLUSION:

  • Vaginal micronized progesterone increased the rate of live births among women with threatened miscarriage and ≥1 previous miscarriage
  • There was no difference in adverse events between treatments and placebo

Learn More – Primary Sources:

Progestogens for preventing miscarriage: a network meta‐analysis

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Related ObG Topics:

EPPPIC Meta-analysis Results: Progestogens for Preterm Birth Prevention
PRISM Trial Results: Does Progesterone for Bleeding Early in Pregnancy Prevent Pregnancy Loss?
A New Biomarker for the Detection of Miscarriage?

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