Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy metformin treatment compared with insulin will result in better perinatal and maternal outcome and improved treatment acceptability with low or noadditional insulin requirement.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dow University of Health Sciences
• Treatments: Insulin; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria

1. Pregnancies in women with pre-pregnancy diagnosis of NIDDM (Type 2 DM) and pregnancy continued beyond the first trimester.

2. Women with gestational diabetes mellitus who are at 20-34 weeks of gestation.

3. Women who have glucose elevations consistent with undiagnosed diabetes in pregnancy.

4. Women with impaired glucose tolerance (IGT) at any gestational age of pregnancy and pregnancy continued beyond first trimester.

5. Singleton pregnancy.

Exclusion Criteria:

1. Women who have contraindication for metformin intake.

2. A recognized fetal anomaly at 14-16 weeks ultrasound examination at the time of study entry.

3. Ruptured membranes at time of study entry.

4. Women with IDDM (Type 1 DM) entering pregnancy.

5. Presence of any other medical disorder like essential hypertension, renal disease, hepatic disease, hypothyroidism, cardiac disease.

6. Presence of diabetic complications.

7. Patient already on Sulphonylureas.

8. Multiple pregnancy.

9. Gestational diabetes controlled on diet alone.

-