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Brief Title: Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome
Official Title: 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)
Study ID: NCT01587378
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Landspital University Hospital, Reykjavik, , Iceland
Haukeland University Hospital, Bergen, , Norway
Nordlandssykehuset HF, Bodø, , Norway
Sykehuset Innlandet, Brumunddal, , Norway
Vestre Viken Hospital Trust, Drammen, , Norway
Vestre Viken Ringerike sykehus, Honefoss, , Norway
Sykehuset Telemark, Skien, , Norway
St Olavs Hospital, Trondheim, , Norway
Sentralsykehuset i Vestfold, Tønsberg, , Norway
Sykehuset Ålesund, Ålesund, , Norway
Karolinska Universitetssjukhus, Stockholm, , Sweden
Norrlands universitetssjukhus, Umeå, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
Name: Eszter I Vanky, md phd
Affiliation: Norwegian University of Science and Technology
Role: STUDY_DIRECTOR