Clinical Trials in Israel / NCT06643741
Recruiting
Observational
Non-Invasive Preeclampsia Screening and Biobank
NCT06643741 · tracked via the Priya Life Science Israel tracker
Condition(s) studied
Preeclampsia (PE)
Study summary
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Eligibility
Inclusion Criteria:
* Subject is female and 18 years of age and older;
* Subject provides a signed and dated informed consent;
* Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation;
* Subject agrees to provide the Sponsor access to any prenatal and postnatal screening or diagnostic test results and supporting data;
* Subject agrees to have UtAPI calculated during their SOC first trimester ultrasound and MAP collected at the first trimester SOC visit;
* Subject agrees to provide up to 25mL of whole blood at each trimester visit;
* Subject agrees to provide relevant medical and pregnancy/postnatal information including outcome.
Exclusion Criteria:
* Subject is unlikely to return for second and third trimester testing;
* Subject is unlikely to have pregnancy outcome data available;
* Previous sample donation under this protocol with the same pregnancy;
* Subject is participating in a blinded aspirin study or taking unknown doses of aspirin.
Primary outcome measure(s)
- Baseline serum samples will be used to evaluate the performance of the Labcorp Preeclampsia Screen assay — From enrollment at 10-14 weeks gestation until pregnancy outcome is available, up to 36 weeks
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).
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Valley Perinatal | Glendale | Arizona | Recruiting |
| Delaware Center for Maternal and Fetal Medicine | Newark | Delaware | Recruiting |
| D&H National Research Centers | Miami | Florida | Terminated |
| Southern Clinical Research Associates | Metairie | Louisiana | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Not Yet Recruiting |
| Cooper University Health Care | Camden | New Jersey | Not Yet Recruiting |
| New Jersey Perinatal Associates | Livingston | New Jersey | Recruiting |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | Recruiting |
| Capital Health | Pennington | New Jersey | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| Lenox Hill Hospital | New York | New York | Recruiting |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | Recruiting |
| Geisinger Medical Center | Danville | Pennsylvania | Not Yet Recruiting |
| University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania | Recruiting |
| Lewis Katz School of Medicine at Temple University | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Chattanooga Medical Research | Chattanooga | Tennessee | Recruiting |
| St. David's Women's Center of Texas | Austin | Texas | Recruiting |
| University of Texas Medical Branch | Galveston | Texas | Recruiting |
| UT Health | Houston | Texas | Recruiting |
| HCA Healthcare, Texas Maternal Fetal Medicine | Houston | Texas | Recruiting |
| Macon & Joan Brock Virginia Health Sciences at Old Dominion University | Norfolk | Virginia | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06643741 on ClinicalTrials.gov ↗ ← All trials in Israel