Comparison of Aneuploidy Risk Evaluations

Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01663350

Acronym

CARE

Enrollment

3000

Registered

2012-08-13

Start date

2012-07-31

Completion date

Unknown

Last updated

2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Edwards Syndrome, Patau Syndrome, Pregnancy, Turners Syndrome

Brief summary

This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years or older at enrollment * Clinically confirmed pregnancy * Gestational age ≥8 weeks, 0 days * Planned or completed prenatal serum screening\* (drawn during 1st and/or 2nd trimester) * Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam) * Able to provide consent for participation using language appropriate forms

Exclusion criteria

* Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment * Prenatal screening determination by Nuchal Translucency (NT) measurement only

Design outcomes

Primary

Measure	Time frame	Description
Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).	12 months	The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.

Countries

United States

Outcome results