MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy

Verinata Health, Inc.10,000 enrolled

Overview

The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS). Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Pregnant Women Prenatal Care

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * Clinically confirmed viable pregnancy at the time of enrollment * Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days * Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators * Able to provide consent for participation using language appropriate forms and consent process Exclusion Criteria: \- Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

Locations (11)

Center for Fetal Medicine

Los Angeles, California, United States

San Francisco Perinatal Associates

San Francisco, California, United States

Women's Clinic of Northern Colorado

Fort Collins, Colorado, United States

Outcomes

Primary Outcomes

Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.

Time frame: 10 months

Data from ClinicalTrials.gov

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