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Grand Rounds

Results from the PregMet2 Trial: Does Metformin Treatment for PCOS Decrease Risk of Late Miscarriage and Preterm Birth?

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BACKGROUND AND PURPOSE:

  • Women with PCOS are at a higher risk for pregnancy complications
  • Previous studies suggested that metformin may prevent adverse pregnancy outcome
  • Løvvik et al. (Lancet Diabetes & Endocrinology, 2019) designed the PregMet2 RCT to determine if metformin can prevent late miscarriage and preterm birth in women with PCOS

METHODS:

  • Randomized, placebo-controlled, double-blind, multicenter trial
  • Participants
    • Women with singleton pregnancies and PCOS aged 18-45 years
  • Randomized to receive either
    • 500 mg metformin 2x daily during first week of treatment, increased to 1000 mg 2x daily from week two until delivery
    • Placebo
  • Primary outcome (intention to treat)
    • Composite incidence of late miscarriage (13w0d-22w6d) and preterm birth (23w0d-36w6d)
  • Secondary outcomes
    • Gestational diabetes | Preeclampsia |Pregnancy-induced hypertension | NICU admission
  • Further analysis
    • Post-hoc individual participant data analysis of pregnancy outcomes
    • Current study data pooled with 2 previous RCTs

RESULTS:

  • 244 women received metformin | 243 received placebo
  • Primary outcome: Late miscarriage and preterm birth (p=0.08)
    • Metformin group: 5%
    • Placebo: 10%
    • Odds ratio (OR) 0.50 (95% CI 0.22–1.08)
  • Secondary outcomes: No significant differences
    • No significant between-group differences in serious adverse outcomes in either mother or offspring
    • No serious drug related adverse outcomes
  • The post-hoc pooled analysis did demonstrate metformin benefit for late miscarriage or preterm delivery (p=0.004)
    • Metformin group: 5%
    • Placebo group: 10%
    • OR 0.43 (95% CI, 0.23–0.79)

CONCLUSION:

  • In the current study, metformin during pregnancy was not of benefit for women with PCOS but when individual data was pooled, there was a significant improvement in late miscarriage or preterm delivery
  • Metformin did not impact gestational diabetes

Learn More – Primary Sources:

Use of metformin to treat pregnant women with polycystic ovary syndrome (PregMet2): a randomized, double-blind, placebo-controlled trial

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Related ObG Topics:

Metformin in Pregnancy
EUROmediCAT Data: Does Metformin Use in the First Trimester of Pregnancy Increase the Risk for Congenital Anomalies?
The MiG-TOFU Study: Gestational Diabetes, Metformin and Metabolic Outcomes in Offspring 7 Years Later
Updated ACOG Guidance on Gestational Diabetes

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