Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a long term randomized controlled study in gestational diabetes mellitus - POEM Study

Bethesda Diabetes Research Center0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Pregnant women with gestational diabetes mellitus (GDM) defined as a FPG >/=
•5,3 mMol and/or an OGTT with a 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 16-34 weeks
•- HbA1c at inclusion <= 48 mmol/mol (6.5% Hb)

•- Diabetes Mellitus before pregnancy, except previous GDM
•- Proteïnuria (ACR > 35 mg/mmol) at screening
•- Malignancy during the last 5 years before inclusion, except non-melanoma skin
•- Psychiatric and/or mood disorder potentially affecting compliance of treatment
•- Chronic liver failure and/or ASAT and/or ALAT > 3x ULN
•- Chronic renal failure with a GFR < 45 ml/min/1.73m2
•- Chronic pulmonary failure with hypoxia
•- Significantly uncontrolled hypertension - SBP > 160 mm Hg despite medical
•- Chronic treatment with oral corticosteroids
•- Intolerance for metformin and/or earlier use of metformin in this pregnancy
•- Membership of the POEM study group
•- Severe fetal anomaly at inclusion - like major neural tube defect or
•malformation of heart and/or large vessels
•- Ruptured membranes
•- Gemelli (twin pregnancy)
•- Bariatric surgery in medical history
•- Current hyperemesis gravidarum

发起方

Bethesda Diabetes Research Center