Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome (PregMet2)

A Prospective, Randomized, Double-blind, Multi-centre Study, Where the Possible Effect of Metformin to Prevent Late Miscarriage and Preterm Delivery is Studied in Women With Polycystic Ovary Syndrome (PCOS)

The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting.

The investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003 consensus criteria, with singleton pregnancy.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

489

Phase

  • Not Applicable

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

      • Reykjavik, Iceland, 101
        • Landspital University Hospital
      • Bergen, Norway, 5000
        • Haukeland University Hospital
      • Bodø, Norway, 1480
        • Nordlandssykehuset HF
      • Brumunddal, Norway, 2380
        • Sykehuset Innlandet
      • Drammen, Norway
        • Vestre Viken Hospital Trust
      • Honefoss, Norway, 3511
        • Vestre Viken Ringerike Sykehus
      • Skien, Norway, 3710
        • Sykehuset Telemark
      • Trondheim, Norway, 7006
        • St Olavs Hospital
      • Tønsberg, Norway, 3116
        • Sentralsykehuset i Vestfold
      • Ålesund, Norway, 6026
        • Sykehuset Ålesund
      • Stockholm, Sweden, 17176
        • Karolinska Universitetssjukhus
      • Umeå, Sweden, 901 85
        • Norrlands Universitetssjukhus
      • Uppsala, Sweden, 75185
        • Uppsala University 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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age: 18-45 years
  • PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion
  • Mode of conception: Any
  • Single, viable fetus, diagnosed by vaginal ultrasound
  • Gestational week at inclusion: week 6 + 0 to 12 + 0
  • Wash out for metformin: at least 7 days
  • Able to communicate fluently in the official language at the study cite or English

Exclusion Criteria:

  • Any type of diabetes (except GDM in former pregnancy)
  • Known liver disease or ALAT > 100 IU/L
  • Known kidney disease or creatinine > 110 μmol/L
  • Known alcohol or drug abuse
  • Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidine, anticoagulation therapy
  • Unsuitable for participation of 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
Placebo Comparator: placebo
identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
Experimental: metformin
Metformin 500 mg tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
combined incidence of late miscarriages and preterm births
Time Frame: at delivery
This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.
at delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NICU admissions and total number of days in NICU/baby
Time Frame: 2 months
2 months
number of patients hospitalized
Time Frame: at delivery
at delivery
Total number of hospitalization days/ hospitalized participant
Time Frame: 2 months
2 months
Prevalence of gestational diabetes
Time Frame: up to delivery
up to delivery
Prevalence of preeclampsia
Time Frame: up to delivery
up to delivery
SNP
Time Frame: at delivery
SNP analysis (genetic analysis)
at delivery

Collaborators and Investigators

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

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.

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 (Actual)

October 1, 2012

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

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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