Clinical trial NCT01587378: Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Polycystic Ovary Syndrome
Keywords: miscarriage
preterm birth
prevention
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Vestre Viken Hospital Trust
name: Landspitali University Hospital
name: Uppsala University Hospital
name: Haukeland University Hospital
name: Karolinska University Hospital
name: St. Olavs Hospital
name: Sykehuset Telemark
name: Alesund Hospital
name: The Hospital of Vestfold
name: Nordlandssykehuset HF
name: Norrlands universitetssjukhus Umeå
name: Sykehuset Innlandet HF
name: Vestre Viken Ringerike Sykehus
First posted: 2012-04-30
Enrollment: 489
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: combined incidence of late miscarriages and preterm births
timeFrame: at delivery
Secondary outcomes:
measure: NICU admissions and total number of days in NICU/baby
timeFrame: 2 months
measure: number of patients hospitalized
timeFrame: at delivery
measure: Total number of hospitalization days/ hospitalized participant
timeFrame: 2 months
measure: Prevalence of gestational diabetes
timeFrame: up to delivery
measure: Prevalence of preeclampsia
timeFrame: up to delivery
measure: SNP
timeFrame: at delivery
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Landspital University Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bodø
country: Norway
facility: Nordlandssykehuset HF
city: Brumunddal
country: Norway
facility: Sykehuset Innlandet
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust
city: Honefoss
country: Norway
facility: Vestre Viken Ringerike sykehus
city: Skien
country: Norway
facility: Sykehuset Telemark
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Tønsberg
country: Norway
facility: Sentralsykehuset i Vestfold
city: Ålesund
country: Norway
facility: Sykehuset Ålesund
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhus
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Eszter I Vanky, md phd
role: STUDY_DIRECTOR
References:
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.
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.