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

July 19, 2016 updated by: Norwegian University of Science and Technology

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Metformin 1000mg x 2 daily. Orally. From Weifa
Drug: Metformin
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 Comparator: 2
Placebo 2 tablets x 2 daily. Orally From Weifa
Drug: Placebo
Placebo 2 tablets x 2 daily. Orally from Weifa
Other Names:
  • Placebo tablets from Weifa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood flow in the umbilical artery and fetal cerebral artery
Time Frame: 24 weeks gestational
24 weeks gestational

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Principal Investigator: Eszter Vanky, MD, Phd, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-000792-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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