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This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All-risk pregnant women | All-risk pregnancies undergoing conventional forms of prenatal screening |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). | The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is comprised of pregnant women at least 18 years of age, who meet the study eligibility criteria. Women who plan or have already completed prenatal screening for fetal aneuploidy during first and/or second trimester, will be recruited from approved participating clinical centers.
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| Name | Affiliation | Role |
|---|---|---|
| Amy J Sehnert, MD | Verinata Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast OB/GYN | San Diego | California | United States | |||
| AD Williams Laboratory |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24571752 | Derived | Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037. |
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Plasma
| Atlanta |
| Georgia |
| United States |
| Prentice Women's Hospital | Chicago | Illinois | United States |
| William Beaumont Hospital | Royal Oak | Michigan | United States |
| University of Minnesota | Minneapolis | Minnesota | United States |
| Washington University | St Louis | Missouri | United States |
| Desert Perinatal Associates | Las Vegas | Nevada | United States |
| St. Peter's University Hospital | New Brunswick | New Jersey | United States |
| Virtua Perinatology Associates of Voorhees | Voorhees Township | New Jersey | United States |
| Northshore University Hospital | Manhasset | New York | United States |
| Winthrop University Hospital | Mineola | New York | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | United States |
| Mount Sinai Medical Center | New York | New York | United States |
| Jacobi Medical Center | The Bronx | New York | United States |
| Lyndhurst Clinical Research | Raleigh | North Carolina | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | United States |
| Maternal Fetal Medicine | Cleveland | Ohio | United States |
| MacDonald Clinical Research Unit | Mayfield Heights | Ohio | United States |
| Network Office of Research and Innovation Lehigh Valley Health Network | Allentown | Pennsylvania | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| South Carolina Clinical Research | Columbia | South Carolina | United States |
| Greenville Hospital Systems | Greenville | South Carolina | United States |
| Jackson Clinic | Jackson | Tennessee | United States |
| Practice Research Organization | Dallas | Texas | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | United States |
| The Group for Women | Norfolk | Virginia | United States |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D000073842 | Trisomy 18 Syndrome |
| D000073839 | Trisomy 13 Syndrome |
| D014424 | Turner Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D052801 | Male Urogenital Diseases |
| D025064 | Sex Chromosome Disorders |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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