NCT06643741 Non-Invasive Preeclampsia Screening and Biobank
| NCT ID | NCT06643741 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sequenom, Inc. |
| Condition | Preeclampsia (PE) |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,550 participants |
| Start Date | 2025-02-02 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,550 participants in total. It began in 2025-02-02 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Eligibility Criteria
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.
Contact & Investigator
Emily Rosenfeld, DO
PRINCIPAL INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Frequently Asked Questions
Who can join the NCT06643741 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia (PE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06643741 currently recruiting?
Yes, NCT06643741 is actively recruiting participants. Contact the research team at mclenng@labcorp.com for enrollment information.
Where is the NCT06643741 trial being conducted?
This trial is being conducted at Glendale, United States, Newark, United States, Miami, United States, Metairie, United States and 11 additional locations.
Who is sponsoring the NCT06643741 clinical trial?
NCT06643741 is sponsored by Sequenom, Inc.. The principal investigator is Emily Rosenfeld, DO at Rutgers Robert Wood Johnson Medical School. The trial plans to enroll 6,550 participants.