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

Primary Purpose

Pregnancy, Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Metformin
placebo
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring miscarriage, preterm birth, prevention

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Landspital University Hospital
  • Haukeland University Hospital
  • Nordlandssykehuset HF
  • Sykehuset Innlandet
  • Vestre Viken Hospital Trust
  • Vestre Viken Ringerike sykehus
  • Sykehuset Telemark
  • St Olavs Hospital
  • Sentralsykehuset i Vestfold
  • Sykehuset Ålesund
  • Karolinska Universitetssjukhus
  • Norrlands universitetssjukhus
  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

metformin

placebo

Arm Description

Outcomes

Primary Outcome Measures

combined incidence of late miscarriages and preterm births
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
number of patients hospitalized
Total number of hospitalization days/ hospitalized participant
Prevalence of gestational diabetes
Prevalence of preeclampsia
SNP
SNP analysis (genetic analysis)

Full Information

First Posted
April 26, 2012
Last Updated
February 24, 2019
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, Alesund Hospital, The Hospital of Vestfold, Nordlandssykehuset HF, Norrlands universitetssjukhus Umeå, Sykehuset Innlandet HF, Vestre Viken Ringerike Sykehus
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1. Study Identification

Unique Protocol Identification Number
NCT01587378
Brief Title
Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome
Acronym
PregMet2
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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, Alesund Hospital, The Hospital of Vestfold, Nordlandssykehuset HF, Norrlands universitetssjukhus Umeå, Sykehuset Innlandet HF, Vestre Viken Ringerike Sykehus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Polycystic Ovary Syndrome
Keywords
miscarriage, preterm birth, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
489 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metformin
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
combined incidence of late miscarriages and preterm births
Description
This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.
Time Frame
at delivery
Secondary Outcome Measure Information:
Title
NICU admissions and total number of days in NICU/baby
Time Frame
2 months
Title
number of patients hospitalized
Time Frame
at delivery
Title
Total number of hospitalization days/ hospitalized participant
Time Frame
2 months
Title
Prevalence of gestational diabetes
Time Frame
up to delivery
Title
Prevalence of preeclampsia
Time Frame
up to delivery
Title
SNP
Description
SNP analysis (genetic analysis)
Time Frame
at delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eszter I Vanky, md phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Landspital University Hospital
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5000
Country
Norway
Facility Name
Nordlandssykehuset HF
City
Bodø
ZIP/Postal Code
1480
Country
Norway
Facility Name
Sykehuset Innlandet
City
Brumunddal
ZIP/Postal Code
2380
Country
Norway
Facility Name
Vestre Viken Hospital Trust
City
Drammen
Country
Norway
Facility Name
Vestre Viken Ringerike sykehus
City
Honefoss
ZIP/Postal Code
3511
Country
Norway
Facility Name
Sykehuset Telemark
City
Skien
ZIP/Postal Code
3710
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Sentralsykehuset i Vestfold
City
Tønsberg
ZIP/Postal Code
3116
Country
Norway
Facility Name
Sykehuset Ålesund
City
Ålesund
ZIP/Postal Code
6026
Country
Norway
Facility Name
Karolinska Universitetssjukhus
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Norrlands universitetssjukhus
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
30792154
Citation
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.
Results Reference
result
PubMed Identifier
34529073
Citation
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.
Results Reference
derived

Learn more about this trial

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

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