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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466622
First Posted: April 27, 2007
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

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.

Condition Intervention Phase
Polycystic Ovary Syndrome Drug: Metformin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Blood flow in the umbilical artery and fetal cerebral artery [ Time Frame: 24 weeks gestational ]

Enrollment: 48
Study Start Date: April 2007
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo tablets from Weifa

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466622


Locations
Norway
Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Eszter Vanky, MD, Phd Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00466622     History of Changes
Other Study ID Numbers: 2004-000792-33
First Submitted: April 26, 2007
First Posted: April 27, 2007
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Norwegian University of Science and Technology:
PCOS
pregnancy
metformin
blood flow
Pulsatility index

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs