Development of a Non-invasive Prenatal Test
Completed
- Conditions
- Pregnancy
- Registration Number
- NCT01451684
- Lead Sponsor
- Cindy Cisneros
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15000
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absence of chromosomal abnormality At time of enrollment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ariosa Diagnostics
🇺🇸San Jose, California, United States