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.
- Conditions
- Pregnant women with a high risk of gestational diabetes mellitus (GDM)Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2014-000446-30-NL
- Lead Sponsor
- Maasstad Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
'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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method