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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Pregnancy, Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin<br> | Drug: Metformin<br>* 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<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combined incidence of late miscarriages and preterm births | This includes spontaneous births, induced vaginal deliveries and operative deliveries on medical indications. | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NICU admissions and total number of days in NICU/baby |  | 2 months | 
| number of patients hospitalized |  | at delivery | 
| Total number of hospitalization days/ hospitalized participant |  | 2 months | 
| Prevalence of gestational diabetes |  | up to delivery | 
| Prevalence of preeclampsia |  | up to delivery | 
| SNP | SNP analysis (genetic analysis) | at delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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miscarriage, preterm birth, prevention