Development of a Prenatal Test for Fetal Aneuploidy Detection

Cindy Cisneros

Status: Completed

Conditions: Fetal Complications

Study type: Observational

Funder types: Industry

Identifiers

NCT01451671

TD002

Details and patient eligibility

About

This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

Enrollment: 1,500 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has singleton pregnancy
• Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
• Subject is able to provide informed consent
• Subject is ≥ 18 years of age

Exclusion criteria

• Subject is pregnant with more than one fetus
• Subject (mother) has a known aneuploidy