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

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

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

Sponsors & Collaborators

• Vestre Viken Hospital Trust

  collaborator OTHER

• Landspitali University Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• Alesund Hospital

  collaborator OTHER

• The Hospital of Vestfold

  collaborator OTHER

• Nordlandssykehuset HF

  collaborator OTHER

• Norrlands universitetssjukhus Umeå

  collaborator UNKNOWN

• Sykehuset Innlandet HF

  collaborator OTHER

• Vestre Viken Ringerike Sykehus

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Eszter I Vanky, md phd · Norwegian University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2017-10-31

Completion

2017-10-31

Countries

• Iceland
• Norway
• Sweden

Study Locations