Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening
NCT ID: NCT03865901
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2019-05-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-diabetic pregnant women
Non-diabetic women with singleton pregnancy undergoing screening for gestational diabetes who provide plasma samples for testing with the Mellitus GCD59 Test
Mellitus GCD59 Test
An ELISA for screening for the risk of gestational diabetes
Interventions
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Mellitus GCD59 Test
An ELISA for screening for the risk of gestational diabetes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has an established viable singleton pregnancy
3. Is recommended for routine GDM screening between 24-28 weeks gestation
4. Has confirmed gestational age of 24-28 weeks at the Screening Visit
5. Is willing and able to provide documentation of informed consent
Exclusion Criteria
2. Has contraindications for drinking oral glucose solution up to 100 g of sugar
3. Is taking metformin for any reason
4. 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
18 Years
FEMALE
No
Sponsors
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Regulatory and Clinical Research Institute Inc
OTHER
Mellitus, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce A Lonergan
Role: STUDY_CHAIR
Mellitus, LLC
Locations
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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
Countries
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Other Identifiers
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CSP-MEL-002
Identifier Type: -
Identifier Source: org_study_id
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