Poly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias: - at least 2 out of 3 criterias 1.PCO in at least one ovary 2.Oligo-/anovulation (clinically diagnosed as oligo-/amenorrhea,i.e. menstrual cycles > 35 days or <10 menstruations/year 3.Hyperandrogenism
Conditions
Interventions
Trade Name: Metformin
Product Name: Metformin
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route
Sponsors
NTNU, Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Age: 18-45 years • PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion. • Mode of conception: Any • Single, viable fetus, diagnosed by vaginal ultrasound • Gestational week at inclusion: week 6 + 0 to 12 + 0. • Wash out for metformin: at least 7 days • Able to communicate fluently in the official language at the study cite or English • Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria • Any type of diabetes (except GDM in former pregnancy). • Known liver disease or ALAT > 100 IU/L • Known kidney disease or creatinine > 110 µmol/L • Known alcohol or drug abuse • Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidin, anticoagulation therapy • Unsuitable for participation of other reasons • Participating in other medical trials in the same period of time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim and primary endpoint of the PregMet 2 Study is to investigate whether metformin prevents late miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting. ; Secondary Objective: Secondary endpoints • NICU admissions and total number of days in NICU/baby • No. of patients hospitalized (except delivery and post partum) • Total number of hospitalization days/ hospitalized participant • The prevalence of gestational diabetes • The prevalence of preeclampsia Tertiary endpoints • Weight gain in pregnancy • Newborn data • Birth weight • Birth length • Head Circumference • Apgar score/ pH , BE from umbilical cord blood • Malformations ; Primary end point(s): Primary endpoints • The combined incidence of late miscarriages and preterm births. This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications. ;Timepoint(s) of evaluation of this end point: All endpoints will be evaluated when the last participant of the studygroup has delivered | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints • NICU admissions and total number of days in NICU/baby • No. of patients hospitalized (except delivery and post partum) • Total number of hospitalization days/ hospitalized participant • The prevalence of gestational diabetes • The prevalence of preeclampsia Tertiary endpoints • Weight gain in pregnancy • Newborn data • Birth weight • Birth length • head circumference • Apgar score/ pH , BE from umbilical cord blood • Malformations ;Timepoint(s) of evaluation of this end point: All endpoints will be evaluated when the last participant of the studygroup given birth | — |
Countries
Denmark, Iceland, Norway, Sweden
Contacts
Public ContactMaternity care, Outpatient Unit
Women's clinic, St. Olavs hospital
Outcome results
None listed