At a glance
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A Prospective, Randomized, Double-blind, Multi-centre Study, Where the Possible Effect of Metformin to Prevent Late Miscarriage and Preterm Delivery is Studied in Women With Polycystic Ovary Syndrome (PCOS)
In Brief
A clinical study evaluating Metformin and placebo for Pregnancy and Polycystic Ovary Syndrome. Completed, enrolled 489 participants across 13 sites in 3 countries.
Detailed Summary
The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting. The investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week \< 37) in PCOS women diagnosed according to Rotterdam 2003 consensus criteria, with singleton pregnancy.
Study Details
Timeline
Interventions
Metformin 500 mg tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery