Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin

Norwegian University of Science and Technology48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminDRUG

1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.

PlaceboDRUG

Placebo 2 tablets x 2 daily. Orally from Weifa

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim

Trondheim, Norway

Outcomes

Primary Outcomes

Pulsatility index of the uterine artery

3 hrs before and after drug intake, 2 weeks after inclusion, and during medication

Time frame: up to delivery

Secondary Outcomes

Blood flow in the umbilical artery and fetal cerebral artery

Time frame: 24 weeks gestational

Data from ClinicalTrials.gov

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