Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin (FlowMet)

Norwegian University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00466622

2004-000792-33

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Metformin 1000mg x 2 daily. Orally. From Weifa

Treatment:

Drug: Metformin

2

Placebo Comparator group

Description:

Placebo 2 tablets x 2 daily. Orally From Weifa

Treatment:

Drug: Placebo