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RECRUITINGOBSERVATIONAL

Non-Invasive Preeclampsia Screening and Biobank

Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.

Who May Be Eligible (Plain English)

Who May Qualify: - Subject is female and 18 years of age and older; - Subject provides a signed and dated willing to sign a consent form; - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (20)

Valley Perinatal
Glendale, Arizona, United States
Delaware Center for Maternal and Fetal Medicine
Newark, Delaware, United States
D&H National Research Centers
Miami, Florida, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cooper University Health Care
Camden, New Jersey, 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
Columbia University Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Lewis Katz School of Medicine at Temple University
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