Comparison of Metformin with Glyburide in gestational diabetes
Phase 3
Completed
- Conditions
- Health Condition 1: null- Pregnant women with gestational diabetes not controlled with medical nutritional therapy (MNT)
- Registration Number
- CTRI/2014/02/004418
- Lead Sponsor
- Christian Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 159
Inclusion Criteria
Pregnant women from 20-33 weeks
Fasting glucose >=99mg% and <=130 mg% and/or 2 hour PC value >= 120mg% and <=250mg% after MNT.
Exclusion Criteria
Pre-existing type 1 or 2 diabetes
Currently taking metformin for some other indication.
Multiple pregnancy.
Recognised foetal congenital anomaly.
Known abnormal renal or liver function.
Hypoxic cardio-respiratory disease.
Mal-absorption or some other significant GI disease.
Sepsis.
Ruptured membranes.
Gestational hypertension or pre-eclampsia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary outcome of the study were a composite of salient neonatal outcomes that include: <br/ ><br>â?¢Macrosomia <br/ ><br>â?¢Birth weight more than 3700gms <br/ ><br>â?¢Hypoglycaemia less than 40mg percent <br/ ><br>â?¢Need for phototherapy <br/ ><br>â?¢Respiratory distress <br/ ><br>â?¢Stillbirth or neonatal deaths <br/ ><br>â?¢Birth trauma <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 20 percent
- Secondary Outcome Measures
Name Time Method Secondary outcomes include: <br/ ><br>â?¢Birth weight <br/ ><br>â?¢Maternal glycaemic control <br/ ><br>â?¢Pregnancy induced hypertension <br/ ><br>â?¢Need for induction of labour <br/ ><br>â?¢mode of delivery <br/ ><br>â?¢complications of delivery such as third and fourth degree perineal tears. <br/ ><br> <br/ ><br>Timepoint: 30 percent