We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01587378
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Pregnancy Polycystic Ovary Syndrome Drug: Metformin Drug: placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 489 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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)
Actual Study Start Date : October 2012
Primary Completion Date : August 2017
Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: metformin Drug: 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
Placebo Comparator: placebo Drug: 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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587378


Locations
Iceland
Landspital University Hospital
Reykjavik, Iceland, 101
Norway
Haukeland University Hospital
Bergen, Norway, 5000
Nordlandssykehuset HF
Bodø, Norway, 1480
Sykehuset Innlandet
Brumunddal, Norway, 2380
Vestre Viken Hospital Trust
Drammen, Norway
Vestre Viken Ringerike sykehus
Honefoss, Norway, 3511
Sykehuset Telemark
Skien, Norway, 3710
St Olavs Hospital
Trondheim, Norway, 7006
Sentralsykehuset i Vestfold
Tønsberg, Norway, 3116
Sykehuset Ålesund
Ålesund, Norway, 6026
Sweden
Karolinska Universitetssjukhus
Stockholm, Sweden, 17176
Norrlands universitetssjukhus
Umeå, Sweden, 901 85
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Norwegian University of Science and Technology
Vestre Viken Hospital Trust
Landspitali University Hospital
Uppsala University Hospital
Haukeland University Hospital
Karolinska University Hospital
St. Olavs Hospital
Sykehuset Telemark
Alesund Hospital
The Hospital of Vestfold
Nordlandssykehuset HF
Norrlands universitetssjukhus Umeå
Sykehuset Innlandet HF
Vestre Viken Ringerike Sykehus
Investigators
Study Director: Eszter I Vanky, md phd Norwegian University of Science and Technology
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01587378     History of Changes
Other Study ID Numbers: 2011/1434
2011-002203-15 ( EudraCT Number )
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
miscarriage
preterm birth
prevention

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Abortion, Spontaneous
Premature Birth
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs