Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement
that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S.
pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the
current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method
has emerged that more accurately identifies women at risk for preeclampsia, warranting
improvements in diagnosing Pre-E.
This sample collection study will obtain serum and urine samples from pregnant women who
present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E.
Samples will be used to evaluate and validate the performance of an assay intended to aid in
assessing the risk of Pre-E.