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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
489
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
identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
Landspital University Hospital
Reykjavik, Iceland
Sykehuset Ålesund
Ålesund, Norway
Haukeland University Hospital
Bergen, Norway
Nordlandssykehuset HF
Bodø, Norway
Sykehuset Innlandet
Brumunddal, Norway
Vestre Viken Hospital Trust
Drammen, Norway
Vestre Viken Ringerike sykehus
Hønefoss, Norway
Sykehuset Telemark
Skien, Norway
St Olavs Hospital
Trondheim, Norway
Sentralsykehuset i Vestfold
Tønsberg, Norway
...and 3 more locations
combined incidence of late miscarriages and preterm births
This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.
Time frame: at delivery
NICU admissions and total number of days in NICU/baby
Time frame: 2 months
number of patients hospitalized
Time frame: at delivery
Total number of hospitalization days/ hospitalized participant
Time frame: 2 months
Prevalence of gestational diabetes
Time frame: up to delivery
Prevalence of preeclampsia
Time frame: up to delivery
SNP
SNP analysis (genetic analysis)
Time frame: at delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.