Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin - Tabular View

Tracking Information

First Received Date ^ICMJE

April 26, 2007

Last Updated Date

February 5, 2009

Start Date ^ICMJE

April 2007

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pulsatility index of the uterine artery before and 3h after first medicine intake [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Pulsatility index of the uterine artery 10-14 days after inclusion, and ongoing medication [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Blood flow in the umbilical artery and fetal cerebral artery at gestational week 24 [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00466622 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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:

before and 3h after the first tablet intake of metformin/placebo
and 10-14 days after inclusion in the trial
blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Polycystic Ovary Syndrome

Intervention ^ICMJE

Drug: Metformin
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Metformin 1000mg x 2 daily. Orally. From Weifa
Placebo Comparator: Placebo 2 tablets x 2 daily. Orally From Weifa

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00466622

Responsible Party

Eszter Vanky and Solhild Stridsklev, Norwegian University of Science and Technology, St.Olavs Hospital

Study ID Numbers ^ICMJE

2004-000792-33

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

St. Olavs Hospital

Investigators ^ICMJE

Principal Investigator:

Eszter Vanky, MD, Phd

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

February 2009

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