Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening

Withdrawn before enrolling

Conditions studied: Gestational Diabetes

In brief

Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)

Key facts

Study ID

NCT03865901

Run by

Mellitus, LLC

People needed

0

Starts

2019-05-01

Expected to finish

2020-09-01

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• UC Irvine Health — Orange, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Christina Care Health System — Newark, Delaware, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• UMass Medical School/UMass Memorial Health Care — Worcester, Massachusetts, United States
• Spectrum Hleath — Grand Rapids, Michigan, United States
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Ohio State University School of Medicine — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Greenville Health System — Greenville, South Carolina, United States
• Austin Maternal-Fetal Medicine — Austin, Texas, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Science Center, San Antonio — San Antonio, Texas, United States
• University of Utah School of Medicine — Salt Lake City, Utah, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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