Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome: an Randomized Control Trial
Overview[ - collapse ][ - ]
| 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 | Pregnancy Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin Drug: placebo |
| Phase | N/A |
| Sponsor | Norwegian University of Science and Technology |
| Responsible Party | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier | NCT01587378 |
| First Received | April 26, 2012 |
| Last Updated | April 3, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 26, 2012 |
|---|---|
| Last Updated Date | April 3, 2014 |
| Start Date | October 2012 |
| Estimated Primary Completion Date | March 2016 |
| Current 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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome: an Randomized Control Trial |
|---|---|
| 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) |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition |
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| Intervention | 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 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1000 |
| Estimated Completion Date | March 2016 |
| Estimated Primary Completion Date | September 2015 |
| Eligibility 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Tone S Løvvik, md 004772575715 tone.shetelig.lovvik@stolav.no |
| Location Countries | Iceland, Norway, Sweden |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01587378 |
|---|---|
| Other Study ID Numbers | 2011/1434 |
| Has Data Monitoring Committee | No |
| Information Provided By | Norwegian University of Science and Technology |
| Study Sponsor | Norwegian University of Science and Technology |
| Collaborators | Vestre Viken Hospital Trust 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 |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Landspital University Hospital | Reykjavik, Iceland, 101 Contact: Berglind Steffensen, md | +35 46955366 | berglins@landspitali.isRecruiting |
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| Haukeland University Hospital | Bergen, Norway, 5000 Contact: Francisco Gomez Real, MD | +47 915 611 46 | francisco.real@med.uib.noRecruiting |
| Vestre Viken Hospital Trust | Drammen, Norway Contact: Kristin Voss Hestvold, mdRecruiting |
| Sykehuset Telemark | Skien, Norway, 3710 Contact: Birgitte M Mork, md | +47 911 49 108 | birgitte.mork@sthf.noRecruiting |
| St Olavs Hospital | Trondheim, Norway, 7006 Contact: Tone S Løvvik, md | +47 97798745 | tone.shetelig.lovvik@stolav.noRecruiting |
| Sentralsykehuset i Vestfold | Tønsberg, Norway, 3116 Contact: Renata Zabielska, md | +47 45881525 | dzabielski@yahoo.comRecruiting |
| Sykehuset Ålesund | Ålesund, Norway, 6026 Contact: Sissel Hjelle, md | +47 70105825 | sissel.hjelle@helse-mr.noRecruiting |
| South General Hospital | Stockholm, Sweden, 11883 Contact: Marie Bixo, md phd | +46 8-616 15 32 | marie.bixo@sodersjukhuset.seRecruiting |
| Karolinska Universitetssjukhus | Stockholm, Sweden, 17176 Contact: Angelica L Hirschberg, md | +46 8 517 733 26 | angelica.linden-hirschberg@karolinska.seRecruiting |
| Uppsala University Hospital | Uppsala, Sweden, 75185 Contact: Inger S Poromaa, md | inger.sundstrom@kbh.uu.seRecruiting |
| Universitetssjukhuset Örebro | Örebro, Sweden, 701 85 Contact: Izabella Jawad, md | izabella.jawad@orebroll.seRecruiting |