Collection of Pregnancy Outcome Data and Whole Blood Samples From Women Undergoing Non-Invasive Screening for Early, Preterm, and Term Preeclampsia
Sequenom, Inc.
Summary
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- 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…
Locations (21)
- Valley PerinatalGlendale, Arizona
- Delaware Center for Maternal and Fetal MedicineNewark, Delaware
- D&H National Research CentersMiami, Florida
- Southern Clinical Research AssociatesMetairie, Louisiana
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Cooper University Health CareCamden, New Jersey