Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, pregnancy, metformin, blood flow, Pulsatility index
Brief summary
FlowMet study is a sub-study of the PregMet study (registered in 2005). The aim of the FlowMet study is to register the possible effect of metformin on the blood flow of the uterine artery in pregnant PCOS women. The participants will be examined with ultrasound Doppler in gestational week 10-13: 1. before and 3h after the first tablet intake of metformin/placebo 2. and 10-14 days after inclusion in the trial 3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.
Interventions
DRUGMetformin
1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.
DRUGPlacebo
Placebo 2 tablets x 2 daily. Orally from Weifa
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
* Same as in the PregMet study. As this study is a sub-study/extended study of the PregMet study, ONLY those included in the PregMet study (NCT00159536) can participate.
Exclusion criteria
* Same as in the PregMet study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulsatility index of the uterine artery | up to delivery | 3 hrs before and after drug intake, 2 weeks after inclusion, and during medication |
Secondary
| Measure | Time frame |
|---|---|
| Blood flow in the umbilical artery and fetal cerebral artery | 24 weeks gestational |
Countries
Norway
Outcome results
None listed