Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus

NCT02275845 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-12-28

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02275845 on ClinicalTrials.gov