NCT02394158

Preventing Recurrent Gestational Diabetes With Metformin

Preventing Recurrent Gestational Diabetes Mellitus With Early Metformin Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.

Detailed description

Gestational diabetes mellitus (GDM) is a common medical complication of pregnancy and is associated with increased risks to mother and baby. The incidence is increasing reflecting changing pre-gravid female demographics. Once one pregnancy is complicated by GDM, subsequent pregnancies are more likely to be affected by the same condition. This reported risk of recurrence is estimated to range between 35 and 80%, with non-caucasian ethnicity being the strongest predictor of GDM recurrence. Evidence regarding further predictors of recurrent GDM is conflicting and measures that might prevent recurrence need exploring. Metformin is commonly used in the treatment of established GDM and has been shown to reduce the incidence of GDM in the context of polycystic ovarian syndrome.

Conditions

• Gestational Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Metformin
DRUG	placebo

Timeline

• Start date: 2015-01-27
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2015-03-20
• Last updated: 2019-08-13

Locations

2 sites across 1 country: United Kingdom