NCT01587378

Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Metformin	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
DRUG	placebo	identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2012-04-30
• Last updated: 2019-02-26

Locations

13 sites across 3 countries: Iceland, Norway, Sweden