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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Pregnancy
• Interventions: Drug: placebo; Drug: Metformin

• Registration Number: NCT01587378
• Lead Sponsor: Norwegian University of Science and Technology

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

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2012-10
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 489

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
combined incidence of late miscarriages and preterm births	at delivery	This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.

Secondary Outcome Measures

Name	Time	Method
NICU admissions and total number of days in NICU/baby	2 months
Prevalence of preeclampsia	up to delivery
number of patients hospitalized	at delivery
Prevalence of gestational diabetes	up to delivery
Total number of hospitalization days/ hospitalized participant	2 months
SNP	at delivery	SNP analysis (genetic analysis)

Trial Locations

Locations (13)

Sykehuset Innlandet; 🇳🇴 Brumunddal, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Nordlandssykehuset HF; 🇳🇴 Bodø, Norway

Vestre Viken Hospital Trust; 🇳🇴 Drammen, Norway

Vestre Viken Ringerike sykehus; 🇳🇴 Honefoss, Norway

Karolinska Universitetssjukhus; 🇸🇪 Stockholm, Sweden

Norrlands universitetssjukhus; 🇸🇪 Umeå, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Sykehuset Ålesund; 🇳🇴 Ålesund, Norway

Sentralsykehuset i Vestfold; 🇳🇴 Tønsberg, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Landspital University Hospital; 🇮🇸 Reykjavik, Iceland

Sykehuset Telemark; 🇳🇴 Skien, Norway