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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polycystic Ovary Syndrome focused on measuring PCOS, pregnancy, metformin, blood flow, Pulsatility index

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Metformin 1000mg x 2 daily. Orally. From Weifa

Placebo 2 tablets x 2 daily. Orally From Weifa

Outcomes

Primary Outcome Measures

Pulsatility index of the uterine artery
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

Full Information

First Posted
April 26, 2007
Last Updated
July 19, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00466622
Brief Title
Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin
Acronym
FlowMet
Official Title
Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, pregnancy, metformin, blood flow, Pulsatility index

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Metformin 1000mg x 2 daily. Orally. From Weifa
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo 2 tablets x 2 daily. Orally From Weifa
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
metformin 500mg tablets from Weifa
Intervention Description
1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablets from Weifa
Intervention Description
Placebo 2 tablets x 2 daily. Orally from Weifa
Primary Outcome Measure Information:
Title
Pulsatility index of the uterine artery
Description
3 hrs before and after drug intake, 2 weeks after inclusion, and during medication
Time Frame
up to delivery
Secondary Outcome Measure Information:
Title
Blood flow in the umbilical artery and fetal cerebral artery
Time Frame
24 weeks gestational

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eszter Vanky, MD, Phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim
City
Trondheim
ZIP/Postal Code
7006
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24423336
Citation
Stridsklev S, Carlsen SM, Salvesen O, 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. Epub 2014 Jan 1.
Results Reference
result
PubMed Identifier
30186323
Citation
Stridsklev S, Salvesen O, Salvesen KA, Carlsen SM, Vanky E. Uterine Artery Doppler in Pregnancy: Women with PCOS Compared to Healthy Controls. Int J Endocrinol. 2018 Aug 16;2018:2604064. doi: 10.1155/2018/2604064. eCollection 2018.
Results Reference
derived

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

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