RecruitingNCT01429389
Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy
Collection of Whole Blood Specimens from Pregnant Women At Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma
Sponsor
Sequenom, Inc.
Enrollment
2,000 participants
Start Date
May 1, 2011
Study Type
OBSERVATIONAL
Conditions
Summary
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria6
- pregnant between 10 and 22 weeks gestation
- years of age or older
- provides signed and dated informed consent
- subject is at increased risk for fetal aneuploidy
- subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
- subject agrees to provide the genetic results of the invasive procedure
Exclusion Criteria2
- Fetal demise at time of specimen sampling
- Previous sample donation under this protocol
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Locations(14)
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NCT01429389
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