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

Polycystic Ovary Syndrome Clinical Trial

— FlowMet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466622
• Other study ID #: 2004-000792-33
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2007
• Last updated: July 19, 2016
• Start date: April 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.
• Placebo
Placebo 2 tablets x 2 daily. Orally from Weifa

Locations

Country	Name	City	State
Norway	Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Stridsklev S, Carlsen SM, Salvesen Ø, Clemens I, Vanky E. Midpregnancy Doppler ultrasound of the uterine artery in metformin- versus placebo-treated PCOS women: a randomized trial. J Clin Endocrinol Metab. 2014 Mar;99(3):972-7. doi: 10.1210/jc.2013-3227. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulsatility index of the uterine artery	3 hrs before and after drug intake, 2 weeks after inclusion, and during medication	up to delivery	No
Secondary	Blood flow in the umbilical artery and fetal cerebral artery		24 weeks gestational	No