Comparison of efficacy and safety of different doses of metformin in women with gestational diabetes mellitus

Phase 3

• Conditions: Health Condition 1: O244- Gestational diabetes mellitus

• Registration Number: CTRI/2023/11/059803
• Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified