Status:
COMPLETED
Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Pregnancy Complications
Eligibility:
FEMALE
18-52 years
Phase:
NA
Brief Summary
Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these ...
Detailed Description
Pregnant women with type 2 diabetes mellitus (T2DM) are at increased risk for miscarriages, birth defects, large infants, and stillbirths. Maintaining blood sugars in the normal range decreases these ...
Eligibility Criteria
Inclusion
- The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history
- Treatment with diet or oral hypoglycemic agents prior to pregnancy.
- Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery.
- Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
- Hemoglobin A1C \<9%
Exclusion
- Gestational age greater than 20 weeks
- Multiple gestations (twins or more gestations)
- Type 1 diabetes by patient history
- Known fetal chromosomal or structural defects
- Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
- Those with a hemoglobin A1C greater than 9%.
- On insulin at the start of pregnancy
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00678080
Start Date
September 1 2008
End Date
August 1 2011
Last Update
November 28 2018
Active Locations (3)
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1
Valley Baptist Hospital
Brownsville, Texas, United States, 78520
2
Lyndon B Johnson Hospital
Houston, Texas, United States, 77026
3
Memorial Hermann Hospital
Houston, Texas, United States, 77030