Status:
UNKNOWN
Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country
Lead Sponsor:
Dow University of Health Sciences
Conditions:
Gestational Diabetes
Type 2 Diabetes
Eligibility:
FEMALE
20-46 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
METHODOLOGY: This randomized clinical study comparing metformin and insulin in the treatment of gestational diabetes and type 2 diabetes in pregnancy was conducted between December 2008 till December...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Pregnancies in women with pre-pregnancy diagnosis of NIDDM (Type 2 DM) and pregnancy continued beyond the first trimester.
- Women with gestational diabetes mellitus who are at 20-34 weeks of gestation.
- Women who have glucose elevations consistent with undiagnosed diabetes in pregnancy.
- Women with impaired glucose tolerance (IGT) at any gestational age of pregnancy and pregnancy continued beyond first trimester.
- Singleton pregnancy.
- Exclusion Criteria:
- Women who have contraindication for metformin intake.
- A recognized fetal anomaly at 14-16 weeks ultrasound examination at the time of study entry.
- Ruptured membranes at time of study entry.
- Women with IDDM (Type 1 DM) entering pregnancy.
- Presence of any other medical disorder like essential hypertension, renal disease, hepatic disease, hypothyroidism, cardiac disease.
- Presence of diabetic complications.
- Patient already on Sulphonylureas.
- Multiple pregnancy.
- Gestational diabetes controlled on diet alone.
- \-
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01855763
Start Date
December 1 2008
End Date
December 1 2013
Last Update
May 16 2013
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