CompletedNot Applicable

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

Iceland, Norway489 participantsStarted 2012-10

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 18-45 years * PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion * Mode of conception: Any * Single, viable fetus, diagnosed by vaginal ultrasound * Gestational week at inclusion: week 6 + 0 to 12 + 0 * Wash out for metformin: at least 7 days * Able to communicate fluently in the official language at the study cite or English Exclusion Criteria: * Any type of diabetes (except GDM in former pregnancy) * Known liver disease or ALAT \> 100 IU/L * Known kidney disease or creatinine \> 110 μmol/L * Known alcohol or drug abuse * Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidine, anticoagulation therapy * Unsuitable for participation of other reasons

What they're measuring

combined incidence of late miscarriages and preterm births

Timeframe: at delivery

Trial details

NCT IDNCT01587378

SponsorNorwegian University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10-31