CTRI/2023/11/059803Not yet recruitingPhase 3
To evaluate the efficacy for glycaemic control and safety profile of different metformin doses in women with Gestational Diabetes mellitus: a pilot two-arm parallel randomized control trial - NI
All India Institute of Medical Sciences New Delhi0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Pregnant women with gestational diabetes mellitus (period of gestation 16-28wks)
- •2. Live singleton fetus (US done to confirm gestational age, viability and rule out multiple pregnancies)
- •3. Age = 18 years
- •4. Enrolled either in the Department of Endocrinology and Metabolism or Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi.
- •5. Willing to comply with study protocol
Exclusion Criteria
- •1. Type 1 diabetes mellitus, secondary diabetes, overt and pre-existing diabetes.
- •2. Known congenital anomalies in fetus
- •3. Pre- eclampsia
- •4. Fetal growth retardation (Abdominal circumference < 25th centile or estimated fetal weight < 10th centile)
- •5. Ruptured membranes
- •6. Intolerance to metformin (severe vomiting requiring intravenous fluids or hospitalization, active Crohn’s or colitis, presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis, a history of diabetic ketoacidosis or history of lactic acidosis)
- •7. Women with alcohol intake during pregnancy
- •8. Congestive heart failure or a history of congestive heart failure and
- •9. Those with contraindications to metformin (serum creatinine of greater than 130 umol/L or creatinine clearance <60 ml/min, moderate to severe liver dysfunction ( >3 times upper limit), shock or sepsis, and previous hypersensitivity to metformin)
Investigators
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