Polycystic Ovary Syndrome
Conditions
Keywords
Metformin, Pregnancy outcome, Androgens
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 850 mg x 1 per day for the first week, and 850 mg x 2 per day for the rest of the study period.. Orally. From inclusion (before gestational week 8) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.
DRUGPlacebo
Placebo, 2 tablets x 1 daily for the first week, and 2 tablets x 2 for the rest of the study period.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.
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 40 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis polycystic ovary syndrome (PCOS ) before pregnancy * BMI 27-40 kg/m2 * Human chorionic gonadotropin, beta subunit (HCG-beta) verified pregnancy week 5-8 * At least one of the following criteria: (1) serum testosteron \> 2,5 nmol/L; (2) Sex hormone binding globulin (SHBG) \< 30 nmol; (3) Fasting C-peptid \> 1,0 nmol/L; (4) Menstrual disturbances: oligo-/amenorrhea or metrorrhagia; (5) Hirsutism
Exclusion criteria
* known liver disease or ALAT \> 60 IU/L * S-creatinin \> 130 micromol/L * diabetes mellitus * alcohol or drug abuse * peroral steroid treatment (except inhalation steroids) * use of cimetidine, anticoagulant, erythromycin or other macrolides * not suitable for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dehydroepiandrosterone sulfate (DHEAS) | up to delivery | (µmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA) |
| Androstenedione | up to delivery | Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. measured by a double antibody technique on an Elecsys 2010 analyser (Roche Diagnostics GmbH, Germany) using reagents and calibrators supplied by the manufacturer |
| Testosterone | up to delivery | Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. measured by a double antibody technique on an Elecsys 2010 analyser (Roche Diagnostics GmbH, Germany) using reagents and calibrators supplied by the manufacturer |
| Sex hormone binding globulin (SHBG) | up to delivery | (nmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA) |
| Free testosterone index | up to delivery | Calculated as total testosterone divided by SHBG and multiplied by a factor of 100. SHBG measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy outcome - placental weight | after delivery | Placental weight (g) measured at birth |
| Pregnancy outcome - Agpar score at 5 minutes | after delivery | Apgar score at 5 minutes |
| Occurence of pregnancy complications | up to 6 weeks post partum | Gestational diabetes (GDM) defined according to World Health Organization (1998) criteria, i.e. 2 h plasma glucose values ≥7.8 mmol/l during an Oral Glucose Tolerance Test (OGTT) with 75 g. Uncomplicated GDM treated with dietary advice only was not ranked among the complications in this study. Pre-eclampsia defined as a blood pressure ≥140/90mmHg with concomitant albuminuria ≥0.3 g/24 h measured on two separate occasions after gestational week 20. Premature delivery was defined as delivery before gestational week 37 + 0 according to an estimated date of delivery, based on mid-trimester ultrasound scan |
| Pregnancy outcome - umbilical artery pH | after delivery | Umbilical artery pH measured in umbilical artery blood, immediately after delivery on a Rapidlab 248pH/Blood Gas Analyzer, using reagents and calibrators supplied by the manufacturer (Bayer Corp., USA) |
| Pregnancy outcome - Agpar score at 10 minutes | after delivery | Apgar score at 10 minutes |
| Pregnancy outcome - gestational age | after delivery | Gestational age at birth (days) |
| Pregnancy outcome - gestational length | after delivery | Gestational length (cm) measured at birth |
| Pregnancy outcome - head circumference | after delivery | Head circumference (cm) measured at birth. |
| Pregnancy outcome - birthweight | after delivery | Birthweight (g) measured at birth |
Countries
Norway
Outcome results
None listed