Non-Invasive Preeclampsia Screening and Biobank
Purpose
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Condition
- Preeclampsia (PE)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
University of Texas Medical Branch
Galveston, Texas 77555
Galveston, Texas 77555
More Details
- Status
- Recruiting
- Sponsor
- Sequenom, Inc.
Detailed Description
To collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (PE) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the Labcorp Preeclampsia ScreenTM assay. Data will be used to examine assay performance and develop new testing methods.