Last updated on January 2019

Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers


Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02780414

Contact Investigators or Research Sites near you

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University of Colorado

Aurora, CO United States
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Yale Medical

New Haven, CT United States
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Northwestern

Chicago, IL United States
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Johns Hopkins Medicine

Baltimore, MD United States
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Duke University

Durham, NC United States
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Good Samaritan Hospital

Cincinnati, OH United States
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University of Oklahoma

Oklahoma City, OK United States
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Geisinger Medical Center

Danville, PA United States
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UT Health Medical School

Houston, TX United States
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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