Non-Invasive Preeclampsia Screening and Biobank
Recruiting · NCT06643741 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sequenom, Inc.
View the official record on ClinicalTrials.gov →What this trial is about
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
21 locations listed across 12 US states.
- 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
- Macon & Joan Brock Virginia Health Sciences at Old Dominion University - Norfolk, Virginia, United States