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Non-Invasive Preeclampsia Screening and Biobank
Non-Invasive Preeclampsia Screening and Biobank

NCT06643741

RecruitingN/A

Sponsor: Sequenom, Inc.

Conditions: Preeclampsia (PE)

Countries: United States

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

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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.
Locations (21)
  • Glendale, Arizona, United States
  • Newark, Delaware, United States
  • Miami, Florida, United States
  • Metairie, Louisiana, United States
  • Boston, Massachusetts, United States
  • Camden, New Jersey, United States
  • Livingston, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • Pennington, New Jersey, United States
  • New York, New York, United States
  • New York, New York, United States
  • Winston-Salem, North Carolina, United States
  • Danville, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Chattanooga, Tennessee, United States
  • Austin, Texas, United States
  • Galveston, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Norfolk, Virginia, United States