Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial

Stopped early

Conditions studied: Trisomy 13, Trisomy 18, Trisomy 21, Aneuploidy

In brief

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.

Key facts

Study ID

NCT01545674

Run by

Natera, Inc.

People needed

937

Starts

2012-01-01

Expected to finish

2023-03-01

Last updated by the study team

2023-03-23

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Singleton pregnancy
• Gestational age between 8 weeks 0 days and 23 weeks, 6 days by best obstetrical estimate
• Mother has a high or moderate risk for trisomy
• Mother is planning to have or has had an amniocentesis or chorionic villus sampling (CVS) procedure

You may not qualify if…

• Unavailability of the father to provide a genetic sample (e.g. sperm donor, non-paternity)
• Egg donor used
• Mother or father have known chromosomal abnormalities (including known balanced translocations)
• Participation in the study in a previous pregnancy
• Pregnancy is a result of IVF with pre-implantation genetic diagnosis

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Adventist Hinsdale Hospital — Hinsdale, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• NY Methodist Hospital — Brooklyn, New York, United States
• Madonna Perinatal — Mineola, New York, United States
• New York University — New York, New York, United States
• The Mount Sinai Hospital — New York, New York, United States
• Columbia University — New York, New York, United States
• Carnegie Imaging for Women — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• University of South Carolina — Columbia, South Carolina, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Mt Sinai Hospital — Toronto, Canada

Full record on ClinicalTrials.gov

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