Pregnant Women, Prenatal Care
Conditions
Keywords
Trisomy 21
Brief summary
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.
Interventions
None listed
Sponsors
Verinata Health, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. | 10 months |
Countries
United States
Outcome results
None listed