Metformin in Pregnant PCOS Women

Norwegian University of Science and Technology257 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

257

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminDRUG

Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study

PlaceboDRUG

Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (10)

Ålesund Hospital

Ålesund, Norway

University hospital of Bergen

Bergen, Norway

Central Hospital of Northern Norway

Bodø, Norway

Buskerud Hospital

Drammen, Norway

Outcomes

Primary Outcomes

Gestational diabetes

Time frame: up to delivery

incidence of metabolic syndrome and neurophysiologic parameters in offspring

Time frame: Within 18 years

Preterm delivery

Time frame: up to delivery

pre-eclampsia

Time frame: up to delivery

Secondary Outcomes

emesis and hyperemesis

Time frame: up to delivery

Breastfeeding

Time frame: One year post partum

weight change

Time frame: up to delivery

blood pressure change

Time frame: up to delivery

Incident of instrumental deliveries

Time frame: at delivery

Hormone levels in mother and offspring

Time frame: up to delivery

Snoring and sleep quality

Time frame: up to delivery

Data from ClinicalTrials.gov

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