Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin
- Registration Number
- NCT00466622
- Lead Sponsor
- Norwegian University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Metformin Metformin 1000mg x 2 daily. Orally. From Weifa 2 Placebo Placebo 2 tablets x 2 daily. Orally From Weifa
- Primary Outcome Measures
Name Time Method Pulsatility index of the uterine artery up to delivery 3 hrs before and after drug intake, 2 weeks after inclusion, and during medication
- Secondary Outcome Measures
Name Time Method Blood flow in the umbilical artery and fetal cerebral artery 24 weeks gestational
Trial Locations
- Locations (1)
Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim
🇳🇴Trondheim, Norway