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Spots Global Cancer Trial Database for Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome

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Trial Identification

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

Interventions

Metformin
placebo

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Eszter I Vanky, md phd

Affiliation: Norwegian University of Science and Technology

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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