Status:
COMPLETED
Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
Lead Sponsor:
Esa M Davis, MD MPH FAAFP
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Gestational Diabetes
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes. Maternal metabolic p...
Detailed Description
Impaired glucose metabolism (gestational diabetes (GDM) and mild hyperglycemia) that occurs during pregnancy is associated with an increased risk for pregnancy complications and is also an early indic...
Eligibility Criteria
Inclusion
- Pregnancy between 18-24 weeks of gestation
- Singleton gestation
- Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania
Exclusion
- Preexisting type 1 or 2 diabetes
- Diabetes diagnosed at less than 24 weeks gestational age (GA)
- Multiple gestations ( e.g. twins or triplets)
- Hypertension requiring medications
- Corticosteroid (IM, oral or IV) use in the 30 days prior to enrollment
- Major congenital anomaly with anticipated preterm delivery due to maternal or fetal indications \< 28 wks GA
- Inability to complete the glucose testing before 30 completed weeks GA
- Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucola solution.
Key Trial Info
Start Date :
August 11 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
921 Patients enrolled
Trial Details
Trial ID
NCT02309138
Start Date
August 11 2015
End Date
June 5 2020
Last Update
July 20 2020
Active Locations (1)
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1
UPMC- Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213