Status:
COMPLETED
Development of a Non-invasive Prenatal Test
Lead Sponsor:
Cindy Cisneros
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
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...
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 p...
Eligibility Criteria
Inclusion
- 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
- Subject is pregnant with more than two fetuses
- Subject is unwilling to undergo a blood draw
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT01451684
Start Date
June 1 2011
End Date
December 1 2019
Last Update
April 30 2020
Active Locations (1)
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1
Ariosa Diagnostics
San Jose, California, United States, 95138