Preventing Recurrent Gestational Diabetes With Metformin

Phase 4

• Conditions: Gestational Diabetes Mellitus
• Interventions: Drug: placebo; Drug: Metformin

• Registration Number: NCT02394158
• Lead Sponsor: Imperial College London

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-01-27
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

• Singleton pregnancy;
• 8-22 weeks gestation
• Previous pregnancy complicated by gestational diabetes

Read More

Exclusion Criteria

• Established pre-existing diabetes (including unrecognised diabetes defined as a fasting plasma glucose ≥ 7.0mmol/L and/ or HbA1c ≥ 48mmol/mol); Contraindications to metformin therapy (creatinine ≥ 130μmol/L/ alanine transaminase ≥ 2.0 x upper limit normal/ previous intolerance to metformin)
• Planned continued antenatal care/ delivery at centre not included in trial
• Planned fast for cultural/ religious reasons e.g. Ramadan

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm placebo	placebo	Matched placebo tablets (500mg) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.
Intervention arm Metformin	Metformin	Metformin (500mg tablets) to start at a dose of 500mg once daily with an increase of 500mg every five days until the maximum dose of 1000mg twice daily is reached.

Primary Outcome Measures

Name	Time	Method
Development of Gestational Diabetes at any point during the course of pregnancy	From 12 weeks pregnancy until the onset of labour

Secondary Outcome Measures

Name	Time	Method
Maternal gestational weight gain	Difference between weight at 12 weeks gestation and 36 weeks gestation
Levels of maternal physical and psychological health as assessed by questionnaires	From 12 weeks gestation until 6 weeks postpartum
Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy).	At Birth
Postpartum glucose levels	6 weeks postpartum
Cost effectiveness of the intervention	From 12 weeks gestation until 6 weeks postpartum	Difference in requirement for medical services and unplanned hospital/ General Practitioner attendances between the two arms
Requirement for insulin therapy	From 12 weeks gestation until 36 weeks gestation
Fetal birthweight and birthweight centile	At Birth

Trial Locations

Locations (2)

London North West Healthcare Trust; 🇬🇧 London, United Kingdom

Imperial College NHS Trust; 🇬🇧 London, United Kingdom