Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6550 participants
OBSERVATIONAL
2025-02-02
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
Yes
Sponsors
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Rutgers Robert Wood Johnson Medical School
OTHER
Laboratory Corporation of America
INDUSTRY
Sequenom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Emily Rosenfeld, DO
Role: PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Locations
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Valley Perinatal
Glendale, Arizona, United States
D&H National Research Centers
Miami, Florida, United States
New Jersey Perinatal Associates
Livingston, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Capital Health
Pennington, New Jersey, United States
Lenox Hill Hospital
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Chattanooga Medical Research
Chattanooga, Tennessee, United States
St. David's Women's Center of Texas
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
UT Health
Houston, Texas, United States
HCA Healthcare, Texas Maternal Fetal Medicine
Houston, Texas, United States
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SQNM-PRE-401
Identifier Type: -
Identifier Source: org_study_id
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