Development of a Non-invasive Prenatal Test

Cindy Cisneros

Status: Completed

Conditions: Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01451684

TD003

Details and patient eligibility

About

This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Full description

Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

Enrollment: 15,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
• Subject is able to provide informed consent
• Subject is ≥ 18 years of age
• Subject is at least 10 weeks gestation for general enrollment
• Subject has no known risk factors for chromosomal abnormalities of the fetus
• Subject has no suspected or confirmed fetal abnormalities

Exclusion criteria

• Subject is pregnant with more than two fetuses
• Subject is unwilling to undergo a blood draw