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

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00466622
First received: April 26, 2007
Last updated: November 16, 2011
Last verified: November 2011
History of Changes

April 26, 2007
November 16, 2011
April 2007
August 2009   (final data collection date for primary outcome measure)
Pulsatility index of the uterine artery [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
3 hrs before and after drug intake, 2 weeks after inclusion, and during medication
  • Pulsatility index of the uterine artery before and 3h after first medicine intake
  • Pulsatility index of the uterine artery 10-14 days after inclusion, and ongoing medication
  • Blood flow in the umbilical artery and fetal cerebral artery at gestational week 24
Complete list of historical versions of study NCT00466622 on ClinicalTrials.gov Archive Site
Blood flow in the umbilical artery and fetal cerebral artery [ Time Frame: 24 weeks gestational ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Polycystic Ovary Syndrome
  • 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
  • Drug: Placebo
    Placebo 2 tablets x 2 daily. Orally from Weifa
    Other Name: Placebo tablets from Weifa
  • Experimental: 1
    Metformin 1000mg x 2 daily. Orally. From Weifa
    Intervention: Drug: Metformin
  • Placebo Comparator: 2
    Placebo 2 tablets x 2 daily. Orally From Weifa
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2010
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00466622
2004-000792-33
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Eszter Vanky, MD, Phd Norwegian University of Science and Technology
Norwegian University of Science and Technology
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP