CTRI/2023/11/059803
Not yet recruiting
Phase 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 enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- All India Institute of Medical Sciences New Delhi
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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)
Outcomes
Primary Outcomes
Not specified
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