Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
112
Imperial College NHS Trust
London, United Kingdom
RECRUITINGLondon North West Healthcare Trust
London, United Kingdom
RECRUITINGDevelopment of Gestational Diabetes at any point during the course of pregnancy
Time frame: From 12 weeks pregnancy until the onset of labour
Maternal gestational weight gain
Time frame: Difference between weight at 12 weeks gestation and 36 weeks gestation
Requirement for insulin therapy
Time frame: From 12 weeks gestation until 36 weeks gestation
Postpartum glucose levels
Time frame: 6 weeks postpartum
Levels of maternal physical and psychological health as assessed by questionnaires
Time frame: From 12 weeks gestation until 6 weeks postpartum
Fetal birthweight and birthweight centile
Time frame: At Birth
Composite of neonatal outcomes (neonatal hypoglycaemia requiring treatment, respiratory distress syndrome requiring oxygen therapy/ continuous positive airway pressure, neonatal hyperbilirubinaemia requiring phototherapy).
Time frame: At Birth
Cost effectiveness of the intervention
Difference in requirement for medical services and unplanned hospital/ General Practitioner attendances between the two arms
Time frame: From 12 weeks gestation until 6 weeks postpartum
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