- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01587378
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Reykjavik, Iceland, 101
- Landspital University Hospital
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Bergen, Norway, 5000
- Haukeland University Hospital
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Bodø, Norway, 1480
- Nordlandssykehuset HF
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Brumunddal, Norway, 2380
- Sykehuset Innlandet
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Drammen, Norway
- Vestre Viken Hospital Trust
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Honefoss, Norway, 3511
- Vestre Viken Ringerike Sykehus
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Skien, Norway, 3710
- Sykehuset Telemark
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Trondheim, Norway, 7006
- St Olavs Hospital
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Tønsberg, Norway, 3116
- Sentralsykehuset i Vestfold
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Ålesund, Norway, 6026
- Sykehuset Ålesund
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Stockholm, Sweden, 17176
- Karolinska Universitetssjukhus
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Umeå, Sweden, 901 85
- Norrlands Universitetssjukhus
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Uppsala, Sweden, 75185
- Uppsala University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
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Experimental: metformin
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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
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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
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This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.
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at delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NICU admissions and total number of days in NICU/baby
Time Frame: 2 months
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2 months
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number of patients hospitalized
Time Frame: at delivery
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at delivery
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Total number of hospitalization days/ hospitalized participant
Time Frame: 2 months
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2 months
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Prevalence of gestational diabetes
Time Frame: up to delivery
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up to delivery
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Prevalence of preeclampsia
Time Frame: up to delivery
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up to delivery
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SNP
Time Frame: at delivery
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SNP analysis (genetic analysis)
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at delivery
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Eszter I Vanky, md phd, Norwegian University of Science and Technology
Publications and helpful links
General Publications
- Lovvik TS, Carlsen SM, Salvesen O, Steffensen B, Bixo M, Gomez-Real F, Lonnebotn M, Hestvold KV, Zabielska R, Hirschberg AL, Trouva A, Thorarinsdottir S, Hjelle S, Berg AH, Andrae F, Poromaa IS, Mohlin J, Underdal M, Vanky E. Use of metformin to treat pregnant women with polycystic ovary syndrome (PregMet2): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 Apr;7(4):256-266. doi: 10.1016/S2213-8587(19)30002-6. Epub 2019 Feb 18.
- Stokkeland LMT, Giskeodegard GF, Ryssdal M, Jarmund AH, Steinkjer B, Madssen TS, Stafne SN, Stridsklev S, Lovvik TS, Iversen AC, Vanky E. Changes in Serum Cytokines Throughout Pregnancy in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2022 Jan 1;107(1):39-52. doi: 10.1210/clinem/dgab684.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Polycystic Ovary Syndrome
- Syndrome
- Premature Birth
- Abortion, Spontaneous
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Metformin
Other Study ID Numbers
- 2011/1434
- 2011-002203-15 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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