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Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome: an Randomized Control Trial (PregMet2)

This study is currently recruiting participants.
Verified January 2013 by Norwegian University of Science and Technology
Sponsor:
Collaborators:
Landspitali University Hospital
Uppsala University Hospital
Haukeland University Hospital
Karolinska University Hospital
St. Olavs Hospital
Sykehuset Telemark
Stockholm South General Hospital
Alesund Hospital
University Hospital Orebro
Vestfold Central Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01587378
First received: April 26, 2012
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Pregnancy
Polycystic Ovary Syndrome
 Drug: Metformin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • combined incidence of late miscarriages and preterm births [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.


Secondary Outcome Measures:
  • NICU admissions and total number of days in NICU/baby [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • number of patients hospitalized [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Total number of hospitalization days/ hospitalized participant [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Prevalence of gestational diabetes [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • Prevalence of preeclampsia [ Time Frame: up to delivery ] [ Designated as safety issue: No ]
  • SNP [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    SNP analysis (genetic analysis)


Estimated Enrollment: 1000
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587378

Contacts
Contact: Tone S Løvvik, md 004772575715 tone.shetelig.lovvik@stolav.no
Contact: Eszter I Vanky, md phd 004772573819 eszter.vanky@ntnu.no

Locations
Iceland
Landspital University Hospital Recruiting
Reykjavik, Iceland, 101
Contact: Berglind Steffensen, md     +35 46955366     berglins@landspitali.is    
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5000
Contact: Francisco Gomez Real, MD     +47 915 611 46     francisco.real@med.uib.no    
Contact: Svein M Skulstad, MD     +47 950 40 589     svein.skulstad@uib.no    
Sykehuset Telemark Recruiting
Skien, Norway, 3710
Contact: Birgitte M Mork, md     +47 911 49 108     birgitte.mork@sthf.no    
St Olavs Hospital Recruiting
Trondheim, Norway, 7006
Contact: Tone S Løvvik, md     +47 97798745     tone.shetelig.lovvik@stolav.no    
Sentralsykehuset i Vestfold Recruiting
Tønsberg, Norway, 3116
Contact: Renata Zabielska, md     +47 45881525     dzabielski@yahoo.com    
Sykehuset Ålesund Recruiting
Ålesund, Norway, 6026
Contact: Sissel Hjelle, md     +47 70105825     sissel.hjelle@helse-mr.no    
Sweden
South General Hospital Recruiting
Stockholm, Sweden, 11883
Contact: Marie Bixo, md phd     +46 8-616 15 32     marie.bixo@sodersjukhuset.se    
Contact: Eva Warghammar     +46 70-4840803     Eva.warghammar@sodersjukhuset.se    
Karolinska Universitetssjukhus Recruiting
Stockholm, Sweden, 17176
Contact: Angelica L Hirschberg, md     +46 8 517 733 26     angelica.linden-hirschberg@karolinska.se    
Uppsala University Hospital Recruiting
Uppsala, Sweden, 75185
Contact: Inger S Poromaa, md         inger.sundstrom@kbh.uu.se    
Contact: Lena Moby     +46 18-6115787     lena.moby@kbh.uu.se    
Universitetssjukhuset Örebro Recruiting
Örebro, Sweden, 701 85
Contact: Izabella Jawad, md         izabella.jawad@orebroll.se    
Sponsors and Collaborators
Norwegian University of Science and Technology
Landspitali University Hospital
Uppsala University Hospital
Haukeland University Hospital
Karolinska University Hospital
St. Olavs Hospital
Sykehuset Telemark
Stockholm South General Hospital
Alesund Hospital
University Hospital Orebro
Vestfold Central Hospital
Investigators
Study Director: Eszter I Vanky, md phd Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01587378     History of Changes
Other Study ID Numbers: 2011/1434, 2011-002203-15
Study First Received: April 26, 2012
Last Updated: January 25, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

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

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

ClinicalTrials.gov processed this record on May 16, 2013