Overview

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.

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