Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial

Launched by NATERA, INC. · Mar 6, 2012

Keywords

ClinConnect 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...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Singleton pregnancy
• • 2. Gestational age between 8 weeks 0 days and 23 weeks, 6 days by best obstetrical estimate
• • 3. Mother has a high or moderate risk for trisomy
• • 4. Mother is planning to have or has had an amniocentesis or chorionic villus sampling (CVS) procedure
• Exclusion Criteria:
• • 1. Unavailability of the father to provide a genetic sample (e.g. sperm donor, non-paternity)
• • 2. Egg donor used
• • 3. Mother or father have known chromosomal abnormalities (including known balanced translocations)
• • 4. Participation in the study in a previous pregnancy
• • 5. Pregnancy is a result of IVF with pre-implantation genetic diagnosis