NCT01545674

Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 937 (actual)
• Sponsor: Natera, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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 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.

Conditions

• Trisomy 13
• Trisomy 18
• Trisomy 21
• Aneuploidy

Interventions

Type	Name	Description
PROCEDURE	Blood Draw	Blood will be drawn from the mother and father

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-04-01
• Completion: 2023-03-01
• First posted: 2012-03-07
• Last updated: 2023-03-23

Locations

29 sites across 6 countries: United States, Canada, Ireland, Italy, South Korea, Spain