Skip to main content
OpenTrials
Completed

NCT Number: NCT00466622

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Trondheim, 7006, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Other names: metformin 500mg tablets from Weifa

Placebo

Drug

Placebo 2 tablets x 2 daily. Orally from Weifa

Other names: Placebo tablets from Weifa

Primary outcomes

  1. Pulsatility index of the uterine artery

    Time frame: up to delivery

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

Secondary outcomes

  1. Blood flow in the umbilical artery and fetal cerebral artery

    Time frame: 24 weeks gestational

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study

Acronym: FlowMet

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 27, 2007
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.