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| Name | Class |
|---|---|
| Obstetrix | UNKNOWN |
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The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maternal blood screening test for fetal aneuploidy | Other | One blood draw of 20 to 30 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis | During the 1st and 2nd trimester of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Porreco, MD | Obstetrix Medical Group of Colorado | Principal Investigator |
| Thomas J Garite, MD | Obstetrix | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Good Samaritan Hospital | Mesa | Arizona | 85202 | United States | ||
| Banner Good Samaritan Hospital |
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plasma, PBMCs
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Phoenix Perinatal Associates, Phoenix Arizona Clinic | Phoenix | Arizona | 85014 | United States |
| Obstetric Perinatal Clinic Tucson (WOMB) | Tucson | Arizona | 85712 | United States |
| Fetal Diagnostic Center | Laguna Hills | California | 92653 | United States |
| Long Beach Memorial Medical Center - Magella Medical Group | Long Beach | California | 90806 | United States |
| Obstetrix Medical Group of California - Hamilton | San Jose | California | 95124 | United States |
| Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center | Denver | Colorado | 80218 | United States |
| Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center | Denver | Colorado | 80220 | United States |
| Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center | Englewood | Colorado | 80113 | United States |
| Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center | Littleton | Colorado | 80122 | United States |
| Obstetrix Medical Group Colorado at Skyridge Medical Center | Lonetree | Colorado | 80124 | United States |
| Maternal Fetal Specialists - Northside Atlanta Geogia | Atlanta | Georgia | 303342 | United States |
| Maternal Fetal Specialist of John's Creek | Duluth | Georgia | 30097 | United States |
| Maternal Fetal Specialists - Gwinnett | Lawrenceville | Georgia | 30045 | United States |
| Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center | Kansas City | Missouri | 64111 | United States |
| Center for Maternal Fetal Medicine - 7 Hills Office | Las Vegas | Nevada | 89052 | United States |
| Center for Maternal Fetal Medicine - Pinto Office | Las Vegas | Nevada | 89106 | United States |
| Center for Maternal Fetal Medicine - Post Road Office | Las Vegas | Nevada | 89148 | United States |
| Regional Obstetrical Consultants, Chattanooga Tennessee | Chattanooga | Tennessee | 37403 | United States |
| Regional Obstetrical Consultants, Knoxville Tennessee | Knoxville | Tennessee | 37920 | United States |
| Texas Prenatal Group of San Antonio | San Antonio | Texas | 78229 | United States |
| Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine | Bellevue | Washington | 98004 | United States |
| Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center | Kirkland | Washington | 98034 | United States |
| Obstetrix Medical Group of Washington, Inc | Seattle | Washington | 98104-3405 | United States |
| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D000073842 | Trisomy 18 Syndrome |
| D000782 | Aneuploidy |
| D002869 | Chromosome Aberrations |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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