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| Name | Class |
|---|---|
| Rutgers Robert Wood Johnson Medical School | OTHER |
| Laboratory Corporation of America | INDUSTRY |
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Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
To collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (PE) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the Labcorp Preeclampsia ScreenTM assay. Data will be used to examine assay performance and develop new testing methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant subjects between 11 and 14 weeks gestation. | This is an observational study and no study-specific intervention is defined. PE screen test results will not be reported back to the physician or subject but will be compared to birth outcome data. |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay | The results of the Preeclampsia Screen assay will be compared to pregnancy outcome data to evaluate how well the assay predicted early onset PE (<34 weeks gestational age) and preterm PE (<37 weeks gestational age). | From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graham McLennan, MS | Contact | (858) 202-9162 | mclenng@labcorp.com | |
| Sarah Danowski, MS | Contact | (858) 349-9162 | danowss@labcorp.com |
| Name | Affiliation | Role |
|---|---|---|
| Emily Rosenfeld, DO | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Perinatal | Recruiting | Glendale | Arizona | 85304 | United States |
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Whole blood processed to plasma and serum will be obtained from all subjects. A subset of subjects will be asked to provide remnant placental tissue following delivery
| Delaware Center for Maternal and Fetal Medicine | Not yet recruiting | Newark | Delaware | 19718 | United States |
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| D&H National Research Centers | Terminated | Miami | Florida | 33155 | United States |
| Southern Clinical Research Associates | Not yet recruiting | Metairie | Louisiana | 70001 | United States |
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| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| Cooper University Health Care | Not yet recruiting | Camden | New Jersey | 08103 | United States |
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| New Jersey Perinatal Associates | Recruiting | Livingston | New Jersey | 07039 | United States |
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| Rutgers Robert Wood Johnson Medical School | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Capital Health | Recruiting | Pennington | New Jersey | 08534 | United States |
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| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
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| Wake Forest University Health Sciences | Not yet recruiting | Winston-Salem | North Carolina | 271057 | United States |
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| Geisinger Medical Center | Not yet recruiting | Danville | Pennsylvania | 17822 | United States |
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| University of Pennsylvania Perelman School of Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Lewis Katz School of Medicine at Temple University | Not yet recruiting | Philadelphia | Pennsylvania | 19140 | United States |
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| Chattanooga Medical Research | Recruiting | Chattanooga | Tennessee | 37412 | United States |
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| St. David's Women's Center of Texas | Recruiting | Austin | Texas | 78758 | United States |
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| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77555 | United States |
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| UT Health | Recruiting | Houston | Texas | 77030 | United States |
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| HCA Healthcare, Texas Maternal Fetal Medicine | Recruiting | Houston | Texas | 77054 | United States |
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| Macon & Joan Brock Virginia Health Sciences at Old Dominion University | Recruiting | Norfolk | Virginia | 23507 | United States |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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