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Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

RecruitingPhase 3Ages 18 Years - 45 YearsFemaleBethesda Diabetes Research Center
NCT02947503 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

One approach to prevent the rising burden of diabetes is to address the issue of gestational diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM increases the risks of complications during pregnancy, at delivery and on the longer term, like type 2 diabetes (T2D) and persistent obesity, in mother and child. Moreover, insulin added to diet as the standard care for GDM has disadvantages for mother (maintenance of hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia, hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer targeting the cause of GDM, may have essential benefits, as suggested by observational studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still lacking.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant women with GDM defined as a Fasting Plasma Glucose (FPG) \> 5,3 mMol and/or an Oral Glucose Tolerance test (OGTT) with a Plasma glucose (PG) \> 7,8 mMol, two hours after the oral intake of 75 gram glucose * Written informed consent * Age 18-45 years * Gestational age at inclusion 16-32 weeks * Glycohemoglobin test (HbA1c) at inclusion ≤ 48 mmol/mol (6.5% Hb) Exclusion Criteria: * Diabetes mellitus before pregnancy, except previous GDM * Proteinuria: Urine Albumin-to-Creatinine Ratio (UACR) \> 35 mg/mmol at screening * Malignancy during the last 5 years before inclusion, except non-melanoma skin cancer * Psychiatric and/or mood disorder potentially affecting compliance of treatment * Chronic liver disease and/or Alanine aminotransferase aspartate transaminase (ASAT) and/or Alanine aminotransferase (ALAT) \> 3x Upper Limit of Normal (ULN). * Chronic renal failure with a Glomerular filtration rate (GFR) \< 45 ml/min/1.73m2 * Chronic pulmonary failure with hypoxia * Significantly uncontrolled hypertension - Systolic blood pressure (SBP) \> 160 mm Hg despite medical treatment * Chronic treatment with corticosteroids * Intolerance for metformin and/or earlier use of metformin in this pregnancy * Membership of the POEM study group * Severe foetal anomaly at inclusion - like major neural tube and/or cardiac malformation * Ruptured membranes * Multiple pregnancy * Inability to understand or read the Dutch language * Bariatric surgery in medical history * Hyperemesis gravidarum
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What it tests

  • Metformin TEVA 850 mg
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Where

4 sites
Martini hospital Groningen
Groningen, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Treant Zorggroep
Hoogenveen, Emmen, Stadskanaal, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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