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Recruiting NCT01429389
Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy
Trial Parameters
Condition Down Syndrome
Sponsor Sequenom, Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,000
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2011-05
Completion 2025-12
All Conditions
Brief Summary
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Eligibility Criteria
Inclusion Criteria: * pregnant between 10 and 22 weeks gestation * 18 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 Criteria: * Fetal demise at time of specimen sampling * Previous sample donation under this protocol
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