Trial Information
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Gestational diabetes
Outcome Time Frame:
up to delivery
Safety Issue:
No
Principal Investigator
Eszter I Vanky, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Norwegian University of Science and Technology
Authority:
Norway: Norwegian Medicines Agency
Study ID:
PregMet
NCT ID:
NCT00159536
Start Date:
February 2005
Completion Date:
October 2009
Related Keywords:
- Polycystic Ovary Syndrome
- PCOS
- metformin
- pregnancy
- preeclampsia
- diabetes
- preterm delivery
- Polycystic Ovary Syndrome