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.
Eligible subjects will provide written informed consent after which demographic and baseline clinical data will be recorded. Collection of whole blood and urine samples will be performed at one or more clinic visits from pregnant women carrying a single fetus with no known fetal abnormalities. Interim study visits will continue every 14 days \[+/- 3 days\] until the subject either: 1) reaches 37 0/7 weeks' gestation, 2) develops Pre-E, 3) delivers, or 4) is lost to follow-up. In addition, a group of pregnant women diagnosed with Pre-E will be enrolled as positive control cases.
Study Type
OBSERVATIONAL
Enrollment
1,730
Center of Research in Women's Health
Birmingham, Alabama, United States
University of Colorado
Aurora, Colorado, United States
Yale Medical
New Haven, Connecticut, United States
Northwestern
Chicago, Illinois, United States
Indiana University Health Physicians Women's Health
Indianapolis, Indiana, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington Univ School of Medicine - Dept of OB-GYN
St Louis, Missouri, United States
Winthrop Clinical Trials Center
Mineola, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
...and 10 more locations
Suspected and Pre-E cases determined by institutional standards
Time frame: about 2 years
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