Comparison of Aneuploidy Risk Evaluations (CARE)

Verinata Health

Status: Completed

Conditions: Turners Syndrome; Patau Syndrome; Down Syndrome; Edwards Syndrome; Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01663350

VER-0007

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

3,000 participants in 1 patient group

All-risk pregnant women

Description:

All-risk pregnancies undergoing conventional forms of prenatal screening