Status:
COMPLETED
Early Gestational Diabetes Screening in the Gravid Obese Woman
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ochsner Health System
Conditions:
Gestational Diabetes
Obesity
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese women (body mass index ≥30.0) will result in improved perinatal outcomes. Specific Aim 2: To test the hypo...
Detailed Description
Over 1/3 of reproductive age women are obese. Obese women have higher rates of adverse pregnancy outcomes, including stillbirth, fetal growth disorders, diabetes, hypertensive diseases and maternal de...
Eligibility Criteria
Inclusion
- Pregnant
- 18 years and older
- Body mass index \>=30.0
- \<20 weeks gestation at presentation for care
Exclusion
- Prior cesarean
- History of bariatric surgery
- Major maternal medical illness (cardiac disease, HIV, hemoglobinopathy, oxygen requirement)
- Chronic prednisone use
- Known fetal anomalies
- Multifetal gestation
Key Trial Info
Start Date :
June 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
962 Patients enrolled
Trial Details
Trial ID
NCT01864564
Start Date
June 18 2013
End Date
August 31 2018
Last Update
June 23 2020
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Ochsner Health System
New Orleans, Louisiana, United States, 70121