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.

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: Metformin  Behavior: Diet and lifestyle advice	Phase III

Further Study Details: 

Primary Outcomes: 1)To investigate the incidence of pregnancy complications and pregnancy outcome in PCOS women with special focus on; a)Gestational diabetes; b)Preterm delivery; c)Preeclampsia; 2)To register the incidence of metabolic syndrome and neuropsycologic parameters in offspring
Secondary Outcomes: To investigate; 1)emesis and hyperemesis in pregnancy; 2) weight development, bloodpressure in participants during pregnancy; 3)Incident of instrumental deliveries; 4)Hormonelevels in mother and offspring; 5)Snoring and sleep quality; 6)Breastfeeding
Expected Total Enrollment:  300

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• 18-45 years,
• PCOS diagnosis according to Rotterdam criteria
• single, viable, ultrasoud 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, anticoagulantia og erytromycin treatment at time of inclusion
• not suitable for other reasons

Please refer to this study by ClinicalTrials.gov identifier  NCT00159536

Eszter I Vanky, MD      +4773868967    eszter.vanky@ntnu.no
Sven M Carlsen, MD, PhD      +4773868567    sven.carlsen@ntnu.no

Norway
      Dept. of Obstetrics and Gynecology, University Hospital of Trondheim, Trondheim,  7006,  Norway; Recruiting

Study chairs or principal investigators

Eszter I Vanky, MD,  Principal Investigator,  Norwegian University of Science and Technology   

Study ID Numbers:  PregMet
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159536
Health Authority: Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services
ClinicalTrials.gov processed this record on 2005-09-13