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

Pregnancy Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587378
• Other study ID #: 2011/1434
• Secondary ID: 2011-002203-15
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 31, 2017

Study information

• Verified date: February 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Polycystic Ovary Syndrome
• Pregnancy
• Premature Birth
• Syndrome

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
• 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

Locations

Country	Name	City	State
Iceland	Landspital University Hospital	Reykjavik
Norway	Sykehuset Ålesund	Ålesund
Norway	Haukeland University Hospital	Bergen
Norway	Nordlandssykehuset HF	Bodø
Norway	Sykehuset Innlandet	Brumunddal
Norway	Vestre Viken Hospital Trust	Drammen
Norway	Vestre Viken Ringerike sykehus	Honefoss
Norway	Sykehuset Telemark	Skien
Norway	Sentralsykehuset i Vestfold	Tønsberg
Norway	St Olavs Hospital	Trondheim
Sweden	Karolinska Universitetssjukhus	Stockholm
Sweden	Norrlands universitetssjukhus	Umeå
Sweden	Uppsala University Hospital	Uppsala

Sponsors (14)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, Haukeland University Hospital, Karolinska University Hospital, Landspitali University Hospital, Nordlandssykehuset HF, Norrlands universitetssjukhus Umeå, St. Olavs Hospital, Sykehuset Innlandet HF, Sykehuset Telemark, The Hospital of Vestfold, Uppsala University Hospital, Vestre Viken Hospital Trust, Vestre Viken Ringerike Sykehus

Countries where clinical trial is conducted

Iceland,  Norway,  Sweden, 

References & Publications (1)

Løvvik TS, Carlsen SM, Salvesen Ø, Steffensen B, Bixo M, Gómez-Real F, Lønnebotn M, Hestvold KV, Zabielska R, Hirschberg AL, Trouva A, Thorarinsdottir S, Hjelle S, Berg AH, Andræ F, Poromaa IS, Mohlin J, Underdal M, Vanky E. Use of metformin to treat preg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	combined incidence of late miscarriages and preterm births	This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications.	at delivery
Secondary	NICU admissions and total number of days in NICU/baby		2 months
Secondary	number of patients hospitalized		at delivery
Secondary	Total number of hospitalization days/ hospitalized participant		2 months
Secondary	Prevalence of gestational diabetes		up to delivery
Secondary	Prevalence of preeclampsia		up to delivery
Secondary	SNP	SNP analysis (genetic analysis)	at delivery