A clinical trial to compare the effects of metformin versus insulin in patients with diabetes in pregnancy.

Phase 4

• Conditions: Health Condition 1: null- Gestational Diabetes Mellitus

• Registration Number: CTRI/2014/08/004835
• Lead Sponsor: R S Medical College Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Mothers with gestational diabetes who has at least one plasma glucose at 24 to 33 gestational weeks

Fasting > 92 mg/dl (5.1 mmol/L) and/or 1 hour post 75 gm glucose value > 180 mg/dl (10 mmol/L) and/or 2 hour post 75 gm glucose value > 153 mg/dl (8.5 mmol/L)

Exclusion Criteria

1. Diagnosis of diabetes before 24 weeks of pregnancy

2. Prepregnancy diagnosis of diabetes

3. HbA1c > 7.5 %

4. Renal, hepatic or cardiac failure

5. Diabetic ketoacidosis

6. Pregnancy with multiple fetuses

7. Fetal growth restriction

8. Ruptured membranes

9. A fetal anomaly

10. Bad obstetric history

11. Preeclampsia & eclampsia

12. Chronic hypertension

13. Other major comorbid illness

14. Placental abnormalities or low lying placenta

15. Oligohydroamnios or polyhydroamnios

16. Gestational Hypertention

17. Unwilling to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Birth weight <br/ ><br>2. Birth weight adjusted for gestational weeks <br/ ><br>Timepoint: 1. 0-24 h after delivery <br/ ><br>2. 0-24 h after delivery <br/ ><br>