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Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial — PreNATUS  

Aneuploidy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01545674
Study type Observational
Source Natera, Inc.
Contact
Status Terminated
Phase
Start date January 2012
Completion date March 2023
View Details
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