Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, metformin, pregnancy, preeclampsia, diabetes, preterm delivery
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.
Interventions
DRUGMetformin
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
DRUGPlacebo
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
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gestational diabetes | up to delivery |
| incidence of metabolic syndrome and neurophysiologic parameters in offspring | Within 18 years |
| Preterm delivery | up to delivery |
| pre-eclampsia | up to delivery |
Secondary
| Measure | Time frame |
|---|---|
| Incident of instrumental deliveries | at delivery |
| emesis and hyperemesis | up to delivery |
| Snoring and sleep quality | up to delivery |
| Hormone levels in mother and offspring | up to delivery |
| Breastfeeding | One year post partum |
| weight change | up to delivery |
| blood pressure change | up to delivery |
Countries
Norway
Outcome results
None listed