Status:
WITHDRAWN
Glyburide Compared to Insulin in the Management of White's Classification A2 Gestational Diabetes
Lead Sponsor:
Tripler Army Medical Center
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the oral administration of glyburide is as effective as insulin in the treatment of gestational diabetes. 1. SYNOPSIS: Infants born to mothers with g...
Detailed Description
PLAN: Women who present for prenatal care are routinely screened for gestational diabetes (GDM) with a one-hour 50gm oral glucose challenge test (GCT). This screening occurs at the first prenatal visi...
Eligibility Criteria
Inclusion
- Pregnant women over age 18 who fail to achieve adequate glucose control on diet therapy alone.
Exclusion
- Delivery planned at other than a participating medical treatment facility.
- Women with preexisting diabetes mellitus or diabetic ketoacidosis.
- Hypersensitivity to study medications
- Underlying vascular disease or medical condition known to affect fetal growth or drug clearance such as: severe chronic hypertension, systemic lupus erythematosis, chronic renal insufficiency, hepatic disease, antiphospholipid antibody syndrome or thrombophilia.
- Fetal anomalies identified on ultrasound prior to initiation of therapy.
- Fetal aneuploidy.
- Diagnosis of GDM made after 32 weeks gestation (fetal growth pattern may be impossible to affect after this gestational age.)
- Use of supplemental herbal/nutraceuticals containing chromium, garlic, gymnema (may cause hypoglycemia).
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00160485
Start Date
June 1 2004
End Date
June 1 2010
Last Update
February 11 2014
Active Locations (1)
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1
Tripler Army Medical Center
Honolulu, Hawaii, United States, 97859