Metformin in Pregnant PCOS Women

Phase 3

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT00159536
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 257

Inclusion Criteria

• 18-45 years,
• PCOS diagnosis according to Rotterdam criteria
• single, viable, ultrasound verified fetus
• if metformin was used at conception and early pregnancy, at least 7 days of "wash out"

Exclusion Criteria

• known liver disease or ALAT > 90 nmol/L
• known renal disease or creatinine > 110 micromol/L
• diabetes mellitus
• alcohol or drug abuse
• peroral steroid treatment
• cimetidine, anticoagulant or erythromycin treatment at time of inclusion
• not suitable for other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo x 2 daily
Metformin	Metformin	Metformin 1000mg x 2 daily

Primary Outcome Measures

Name	Time	Method
Preterm delivery	up to delivery
pre-eclampsia	up to delivery
incidence of metabolic syndrome and neurophysiologic parameters in offspring	Within 18 years
Gestational diabetes	up to delivery

Secondary Outcome Measures

Name	Time	Method
blood pressure change	up to delivery
Breastfeeding	One year post partum
Hormone levels in mother and offspring	up to delivery
Incident of instrumental deliveries	at delivery
weight change	up to delivery
emesis and hyperemesis	up to delivery
Snoring and sleep quality	up to delivery

Trial Locations

Locations (10)

University hospital of Bergen; 🇳🇴 Bergen, Norway

Central Hospital of Northern Norway; 🇳🇴 Bodø, Norway

Buskerud Hospital; 🇳🇴 Drammen, Norway

Haugesund Hospital; 🇳🇴 Haugesund, Norway

Ringerike Hospital; 🇳🇴 Hønefoss, Norway

Elvebredden Gynekologpraksis; 🇳🇴 Kristiansand, Norway

Lillehammer Hospital; 🇳🇴 Lillehammer, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital; 🇳🇴 Trondheim, Norway

Ålesund Hospital; 🇳🇴 Ålesund, Norway