Clinical Trial: Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS)

Brief Summary: This prospective blinded study will assess the diagnostic capability of an informatics enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying a fetus with an aneuploidy from fee floating DNA in the maternal blood.

Detailed Summary: First trimester screening is the current standard of care for pregnant women in the United States. Women with a high screening risk for trisomy then have invasive testing, which carries a risk of miscarriage, to definitively determine if the fetus has trisomy. Because of the high false negative rate of the first trimester screening, an unacceptable number of trisomic fetuses are not detected. Moreover, because of the high false positive rate, an unacceptable number of women undergo invasive follow up testing. Additional screening tests are needed that combine a high sensitivity, a low false positive rate, and minimal or no risk to the fetus.
Sponsor: Natera, Inc.

Current Primary Outcome: Sensitivity and Specificity of the test to diagnose aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y. [ Time Frame: Between first trimester screening (10-14 weeks GA) and invasive testing (amniocentesis or CVS). ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Natera, Inc.

Dates:
Date Received: March 1, 2012
Date Started: January 2012
Date Completion: December 2017
Last Updated: April 12, 2017
Last Verified: April 2017