Metformin in Pregnant PCOS Women (PregMet)

February 11, 2019 updated by: Norwegian University of Science and Technology

Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • University hospital of Bergen
      • Bodø, Norway
        • Central Hospital of Northern Norway
      • Drammen, Norway
        • Buskerud Hospital
      • Haugesund, Norway
        • Haugesund Hospital
      • Hønefoss, Norway
        • Ringerike Hospital
      • Kristiansand, Norway
        • Elvebredden Gynekologpraksis
      • Lillehammer, Norway
        • Lillehammer Hospital
      • Stavanger, Norway
        • Stavanger University Hospital
      • Trondheim, Norway
        • Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital
      • Ålesund, Norway
        • Ålesund Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-45 years,
  • PCOS diagnosis according to Rotterdam criteria
  • single, viable, ultrasound verified fetus
  • if metformin was used at conception and early pregnancy, at least 7 days of "wash out"

Exclusion Criteria:

  • known liver disease or ALAT > 90 nmol/L
  • known renal disease or creatinine > 110 micromol/L
  • diabetes mellitus
  • alcohol or drug abuse
  • peroral steroid treatment
  • cimetidine, anticoagulant or erythromycin treatment at time of inclusion
  • not suitable for other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Metformin 1000mg x 2 daily
Drug: Metformin
Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Other Names:
  • metformin from Weifa 500 mg / tablet
Placebo Comparator: placebo
Placebo x 2 daily
Drug: Placebo
Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Other Names:
  • Placebo from Weifa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gestational diabetes
Time Frame: up to delivery
up to delivery
incidence of metabolic syndrome and neurophysiologic parameters in offspring
Time Frame: Within 18 years
Within 18 years
Preterm delivery
Time Frame: up to delivery
up to delivery
pre-eclampsia
Time Frame: up to delivery
up to delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
emesis and hyperemesis
Time Frame: up to delivery
up to delivery
Breastfeeding
Time Frame: One year post partum
One year post partum
weight change
Time Frame: up to delivery
up to delivery
blood pressure change
Time Frame: up to delivery
up to delivery
Incident of instrumental deliveries
Time Frame: at delivery
at delivery
Hormone levels in mother and offspring
Time Frame: up to delivery
up to delivery
Snoring and sleep quality
Time Frame: up to delivery
up to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Principal Investigator: Eszter I Vanky, MD, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PregMet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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