Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial. The Medico-GDM trial. - Metformin to prevent gestational diabetes mellitus (GDM)

Maasstad Ziekenhuis0 个研究点开始时间: 2014年4月1日最近更新: 2017年5月22日

试验速览

暂无简介。

•'High risk' is defined if one or more of the risk factors below is present,
•according to the Dutch national criteria for screening
•- Gestational diabetes in history
•- Body mass index > 30 (kg/m2) at the first prenatal screening
•- Birth weight previous child > P95 or > 4500 gram
•- First degree relative with diabetes mellitus
•- Certain ethnic groups with a high prevalence of diabetes mellitus
•(South Asians, like Hindustani, Afro-Caribbean people, women from the
•Middle East, Morocco and Egypt)
•- History of unexplained intra-uterine foetal death/stillbirth
•- Polycystic ovary syndrome (PCOS)
•And aged between 18 and 40 years, gestational age between 8 and 12 weeks, able to communicate and read in Dutch
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•No singleton pregnancy judged by ultrasonography, high fasting glucose
•at first trimester, cardiac insufficiency, renal insufficiency (MDRD < 60), liver disease, use of medication other than Paracetamol or vitamins and incompetent women.

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