Non-Invasive Preeclampsia Screening and Biobank
Part of paid clinical trials in Glendale, Arizona.
- Sponsor
- Sequenom, Inc.
- Study ID
- NCT06643741
- Status
- Recruiting
Conditions
- Preeclampsia (PE)
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Key Dates
- Start date
- Feb 2, 2025
- Status verified
- Jun 2026
- Primary completion
- Jun 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 6,550 participants (estimated)
Arms
- Arm: 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.
Primary Outcome Measure
Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay [ Time Frame: From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks ]
Central Contacts
- Graham McLennan, MS(858) 202-9162
- Sarah Danowski, MS(858) 349-9162
Locations (21)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Valley Perinatal | Glendale | Arizona | 85304 | Ravindu Gunatilake, MD (PRINCIPAL_INVESTIGATOR) |
| Delaware Center for Maternal and Fetal Medicine | Newark | Delaware | 19718 | Suneet Chauhan, MD, DSc (PRINCIPAL_INVESTIGATOR) |
| D&H National Research Centers | Miami | Florida | 33155 | - |
| Southern Clinical Research Associates | Metairie | Louisiana | 70001 | Samuel Alexander, MD (PRINCIPAL_INVESTIGATOR) |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Cassandra Duffy, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Cooper University Health Care | Camden | New Jersey | 08103 | Robin Perry, MD, MSEd (PRINCIPAL_INVESTIGATOR) |
| New Jersey Perinatal Associates | Livingston | New Jersey | 07039 | Megha Soni Kathy Mathews, MD (PRINCIPAL_INVESTIGATOR) |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | Emily Rosenfeld, DO (PRINCIPAL_INVESTIGATOR) |
| Capital Health | Pennington | New Jersey | 08534 | Thomas Westover, MD (PRINCIPAL_INVESTIGATOR) |
| Columbia University Medical Center | New York | New York | 10032 | Eve Overton, MD (PRINCIPAL_INVESTIGATOR) |
| Lenox Hill Hospital | New York | New York | 10075 | Eran Bornstein, MD (PRINCIPAL_INVESTIGATOR) |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 271057 | David Stamilio, MD, MS (PRINCIPAL_INVESTIGATOR) |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | Michael Paglia, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Lewis Katz School of Medicine at Temple University | Philadelphia | Pennsylvania | 19140 | Laura Hart, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | Lorraine Dugoff, MD (PRINCIPAL_INVESTIGATOR) |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37412 | Scott Harsberger, MD (PRINCIPAL_INVESTIGATOR) |
| St. David's Women's Center of Texas | Austin | Texas | 78758 | Mollie McDonnold, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas Medical Branch | Galveston | Texas | 77555 | Sonia Robazetti, RN Hassan Harirah, MD, FRCSC (PRINCIPAL_INVESTIGATOR) |
| HCA Healthcare, Texas Maternal Fetal Medicine | Houston | Texas | 77054 | Kjersti Aagaard, MD, PhD, FACOG (PRINCIPAL_INVESTIGATOR) |
| UT Health | Houston | Texas | 77030 | Baha M Sibai, MD (PRINCIPAL_INVESTIGATOR) |
| Macon & Joan Brock Virginia Health Sciences at Old Dominion University | Norfolk | Virginia | 23507 | George Saade, MD (PRINCIPAL_INVESTIGATOR) |
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