Clinical trial NCT03865901: Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening
Official title: Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gestational Diabetes
Keywords: in vitro diagnostic
GDM
gestational diabetes mellitus
screening
pregnancy
prenatal care
women's health
Lead sponsor: Mellitus, LLC
Sponsor class: INDUSTRY
Collaborators: name: Regulatory and Clinical Research Institute Inc
First posted: 2019-03-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nondiabetic women with a singleton pregnancy recommended for routine GDM screening between 24-28 weeks gestation

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 risk for GDM. Sensitivity and specificity of the Mellitus GCD59 ELISA will also be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Women 18 years of age or older at enrollment
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:

1. Has diabetes before pregnancy or has already been diagnosed with GDM
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

Primary outcomes:
measure: Negative predictive value (NPV) and positive predictive value (PPV) of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening
timeFrame: The 24-28th gestational week of singleton pregnancy
Secondary outcomes:
measure: Sensitivity and specificity of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening, using two or more abnormal OGTT results (abnormal for OGTT as defined by Carpenter and Coustan diagnostic criteria)
timeFrame: The 24-28th gestational week of singleton pregnancy
measure: NPV, PPV, sensitivity and specificity of the GCD59 ELISA for the risk of GDM using one or more abnormal OGTT results
timeFrame: The 24-28th gestational week of singleton pregnancy
measure: Sensitivity and specificity of the GCD59 ELISA to that of glucose load test (GLT) using two or more abnormal oral glucose tolerance test (OGTT) results
timeFrame: The 24-28th gestational week of singleton pregnancy
Other outcomes:
measure: Negative predictive value (NPV) and positive predictive value (PPV) of the GCD59 ELISA for a range of gestational diabetes mellitus (GDM) prevalence values likely to be encountered in clinical practice in the United States
timeFrame: The 24-28th gestational week of singleton pregnancy
measure: Sensitivity and specificity of the GCD59 ELISA across relevant subgroups
timeFrame: The 24-28th gestational week of singleton pregnancy
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Orange
country: United States
facility: UC Irvine Health
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Newark
country: United States
facility: Christina Care Health System
state: Delaware
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Medical School/UMass Memorial Health Care
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Hleath
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University School of Medicine
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Austin
country: United States
facility: Austin Maternal-Fetal Medicine
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center, San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Mellitus, LLC
name: Joyce A Lonergan
role: STUDY_CHAIR
References: