Status:
UNKNOWN
Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus
Lead Sponsor:
Maasstad Hospital
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
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
Detailed Description
Rationale: GDM is a frequent pregnancy complication1 and associated with complications for mother and child.2 At present, the drug of choice for treatment of GDM is Insulin.3 In the last years several...
Eligibility Criteria
Inclusion
- a subject must meet all of the following criteria:
- high risk (according to ductch national criteria) for gestational diabetes
- aged between 18 and 40 years
- gestational age between 8 and 12 weeks
- and able to communicate and read in Dutch.
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- no singleton pregnancy judged by ultrasonography
- diagnosis of diabetes mellitus before the current pregnancy-
- high fasting glucose at first trimester (\> 5.3 mmol/l)
- cardiac insufficiency-\\
- renal insufficiency (MDRD \< 60)
- liver disease
- use of medication other than Paracetamol or vitamins and incompetent women.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02275845
Start Date
September 1 2014
End Date
September 1 2017
Last Update
December 28 2015
Active Locations (1)
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1
Maasstad Ziekenhuis
Rotterdam, Netherlands