Metformin in the Prevention of Gestational Diabetes: The MPG Trial
Phase 4
- Conditions
- Recurrent gestational DiabetesReproductive Health and Childbirth - Antenatal careMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12610000157077
- Lead Sponsor
- The Women's and Children's Hospital, a facility of the Children, Youth and Women’s Health Service Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 266
Inclusion Criteria
Previous gestational diabetes,
Current viable, singleton pregnancy,
Gestational age=12 weeks 0 days to 15 weeks 6 days.
Exclusion Criteria
Known Type 1, Type 2 or current gestational diabetes.
Abnormal renal or liver function, hypoxic cardio-repsiratory disease, malabsorption or significant gatro intestinal disorder, excessive alcohol intake, recreational drug use in pregnancy, known fetal anomaly, multiple gestation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnosis of recurrent Gestational Diabetes - as determined either by Oral Glucose Tolerance Test or by high blood glucose levels on home blood glucose monitoring.[26-28 weeks and 35-36 gestation]
- Secondary Outcome Measures
Name Time Method Pregnancy hypertensive complication (with or without proteinuria) - as adjudged by the criteria of the Australian Society for the Study of Hypertension in Pregnancy (ASSHP).[Any stage after randomisation];Neonatal outcomes - composite of neonatal hypoglycaemia (heel prick testing of blood glucose levels in the neonate), respiratory distress (need for oxygen), need for phototherapy (diagnosis of hyperbilirubinaemia from a blood test), birth trauma, 5 minute apgar score<7, and prematurity.[At birth];Fetal macrosomia and neonatal adiposity. Fetal ultrasound will be used to assess growth of baby before birth. After birth the baby will be weighed on scales and skinfold thicknesses measured using skinfold callipers.[Measured at birth and at 6 weeks post partum (for neonatal adiposity).]