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

• Status: Completed
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborators: Alesund Hospital; Haukeland University Hospital; Karolinska University Hospital; Landspitali University Hospital; Nordlandssykehuset HF; Norrlands universitetssjukhus Umeå; St. Olavs Hospital; Sykehuset Innlandet HF; Sykehuset Telemark; The Hospital of Vestfold; Uppsala University Hospital; Vestre Viken Hospital Trust; Vestre Viken Ringerike Sykehus
• Treatments: Metformin

Criteria

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