Skip to main content
OpenTrials
Completed

NCT Number: NCT01587378

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Abortion, Spontaneous Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Obstetric Labor Complications Obstetric Labor, Premature Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Landspital University Hospital, Reykjavik, Iceland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Placebo

Drug

identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery

Primary outcomes

  1. 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.

Secondary outcomes

  1. NICU admissions and total number of days in NICU/baby

    Time frame: 2 months

  2. number of patients hospitalized

    Time frame: at delivery

  3. Total number of hospitalization days/ hospitalized participant

    Time frame: 2 months

  4. Prevalence of gestational diabetes

    Time frame: up to delivery

  5. Prevalence of preeclampsia

    Time frame: up to delivery

  6. SNP

    Time frame: at delivery

    SNP analysis (genetic analysis)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Alesund Hospital
  • Haukeland University Hospital
  • Karolinska University Hospital
  • Landspitali University Hospital
  • Nordlandssykehuset HF
  • St. Olavs Hospital
  • Sykehuset Innlandet HF
  • Sykehuset Telemark
  • The Hospital of Vestfold
  • University Hospital, Umeå
  • Uppsala University Hospital
  • Vestre Viken Hospital Trust
  • Vestre Viken Ringerike Sykehus

Registry information

Official study title

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)

Acronym: PregMet2

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 30, 2012
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.