Status:
WITHDRAWN
Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening
Lead Sponsor:
Mellitus, LLC
Collaborating Sponsors:
Regulatory and Clinical Research Institute Inc
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Brief Summary
Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)
Detailed Description
Validate the performance of the Mellitus GCD59 ELISA as a screening test for GDM by evaluating its negative predictive value (NPV) and positive predictive value (PPV) to identify pregnant women at ris...
Eligibility Criteria
Inclusion
- Women 18 years of age or older at enrollment
- Has an established viable singleton pregnancy
- Is recommended for routine GDM screening between 24-28 weeks gestation
- Has confirmed gestational age of 24-28 weeks at the Screening Visit
- Is willing and able to provide documentation of informed consent
Exclusion
- Has diabetes before pregnancy or has already been diagnosed with GDM
- Has contraindications for drinking oral glucose solution up to 100 g of sugar
- Is taking metformin for any reason
- Has any concomitant illness, disease or condition that, in the clinical judgment of the investigator, is likely to prevent the subject from complying with any aspect of the protocol, or that may put the subject at unacceptable risk
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03865901
Start Date
May 1 2019
End Date
September 1 2020
Last Update
September 17 2019
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama
Birmingham, Alabama, United States, 35294
2
UC Irvine Health
Orange, California, United States, 92868
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
4
Christina Care Health System
Newark, Delaware, United States, 19713