Development of a Non-invasive Prenatal Test

Cindy Cisneros15,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

15,000

Conditions

Pregnancy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ariosa Diagnostics

San Jose, California, United States

Outcomes

Primary Outcomes

Absence of chromosomal abnormality

Time frame: At time of enrollment

Data from ClinicalTrials.gov

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