Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus
NCT02275845 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2015-12-28
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
Conditions
- Gestational Diabetes Mellitus
Interventions
- DRUG
-
Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg (from 14 weeks pregnancy untill delivery)
- OTHER
-
control diet
2000 calories/day diet, with an adequate distribution of carbohydrates during the day
Sponsors & Collaborators
-
Maasstad Hospital
lead OTHER
Principal Investigators
-
Joke van der Linden, dr. · Maasstad Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2016-09-30
- Completion
- 2017-09-30
Countries
- Netherlands
Study Locations
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