Gestational Diabetes Mellitus
Conditions
Keywords
Recurrent Gestational Diabetes Mellitus, Prevention, Metformin
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.
Interventions
DRUGMetformin
DRUGplacebo
Sponsors
Imperial College Healthcare NHS Trust
London North West Healthcare NHS Trust
The Novo Nordisk UK Research Foundation
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Singleton pregnancy; * 8-22 weeks gestation * Previous pregnancy complicated by gestational diabetes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of Gestational Diabetes at any point during the course of pregnancy | From 12 weeks pregnancy until the onset of labour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum glucose levels | 6 weeks postpartum | — |
| Fetal birthweight and birthweight centile | At Birth | — |
| Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy). | At Birth | — |
| 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 |
| Maternal gestational weight gain | Difference between weight at 12 weeks gestation and 36 weeks gestation | — |
| Requirement for insulin therapy | From 12 weeks gestation until 36 weeks gestation | — |
| Levels of maternal physical and psychological health as assessed by questionnaires | From 12 weeks gestation until 6 weeks postpartum | — |
Other
| Measure | Time frame |
|---|---|
| Fetal hyperinsulinaemia | Delivery |
| Insulin resistance | From 12 weeks gestation until 6 weeks postpartum |
| Maternal triglyceride concentrations | From 12 weeks gestation until 6 weeks postpartum |
Countries
United Kingdom
Contacts
Primary ContactStephen Robinson, FRCP, MD
Backup ContactRochan Agha-Jaffar, BMBS, MRCP
Outcome results
None listed