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Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers (NCT02780414)

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.
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Female
Accepts Healthy Volunteers
No
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.

5 locations

United States (5)
  • Center of Research in Women's Health
    recruiting
    Birmingham, Alabama, United States, 35294
  • Indiana University Health Physicians Women's Health
    recruiting
    Indianapolis, Indiana, United States, 46202
  • University of North Carolina at Chapel Hill
    recruiting
    Chapel Hill, North Carolina, United States, 27599-7516
  • University of Texas Medical Branch, Galveston
    recruiting
    Galveston, Texas, United States, 77555
  • University of Utah Hospital, OB/GYN Dept.
    recruiting
    Salt Lake City, Utah, United States, 84132
Status:
unknown
Type:
Observational
Phase:
-
Start:
31 December, 2015
Updated:
18 May, 2016
Participants:
1791
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