Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maasstad Hospital
• Treatments: Metformin

Criteria

Inclusion Criteria:

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 Criteria:

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.