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

NCT00466622 | Completed Phase 3

• 1 other identifier: 2004-000792-33
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS; pregnancy; metformin; blood flow; Pulsatility index

Outcome Measures

Primary Outcomes (1)

• Pulsatility index of the uterine artery

  3 hrs before and after drug intake, 2 weeks after inclusion, and during medication

  up to delivery

Secondary Outcomes (1)

• Blood flow in the umbilical artery and fetal cerebral artery

  24 weeks gestational

Study Arms (2)

1

EXPERIMENTAL

Metformin 1000mg x 2 daily. Orally. From Weifa

Drug: Metformin

2

PLACEBO COMPARATOR

Placebo 2 tablets x 2 daily. Orally From Weifa

Drug: Placebo

Interventions

Metformin DRUG

1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.

Also known as: metformin 500mg tablets from Weifa

1

Placebo DRUG

Placebo 2 tablets x 2 daily. Orally from Weifa

Also known as: Placebo tablets from Weifa

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Same as in the PregMet study

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

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

Trondheim, 7006, Norway

Location

Related Publications (2)

• 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.

  PMID: 24423336 RESULT

• 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.

  PMID: 30186323 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Eszter Vanky, MD, Phd

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

NO (1)