Clinical Trial: Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: 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 Quanti
Brief Summary: The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Detailed Summary: To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.
Sponsor: Sequenom, Inc.
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sequenom, Inc.
Dates:
Date Received: September 2, 2011
Date Started: May 2011
Date Completion: March 2017
Last Updated: October 27, 2016
Last Verified: October 2016