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

Start Over

Alan Tita, MD, MPH, PhD

Center of Research in Women's Health
Birmingham, AL United States
  Connect »

David Haas, MD, MS

Indiana University Health Physicians Women's Health
Indianapolis, IN United States
  Connect »

Kim Boggess, MD

University of North Carolina at Chapel Hill
Chapel Hill, NC United States
  Connect »

Maged Costantine, MD

University of Texas Medical Branch, Galveston
Galveston, TX United States
  Connect »

Erin Clark, MD

University of Utah Hospital, OB/GYN Dept.
Salt Lake City, UT United States
  Connect »

Emily Su, MD, MSCI

University of Colorado
Aurora, CO United States
  Connect »

Audrey Merriman, MD

Yale Medical
New Haven, CT United States
  Connect »

William Grobman, MD

Chicago, IL United States
  Connect »

Irina Burd, MD

Johns Hopkins Medicine
Baltimore, MD United States
  Connect »

Tony Wen, MD

University of Mississippi Medical Center
Jackson, MS United States
  Connect »

George Macones, MD

Washington Univ School of Medicine - Dept of OB-GYN
Saint Louis, MO United States
  Connect »

Martin Chavez, MD

Winthrop Clinical Trials Center
Mineola, NY United States
  Connect »

Chad Grotegut, MD

Duke University
Durham, NC United States
  Connect »

Mounira Habli, MD

Good Samaritan Hospital
Cincinnati, OH United States
  Connect »

Rodney Edwards, MD

University of Oklahoma
Oklahoma City, OK United States
  Connect »

Michael Paglia, MD

Geisinger Medical Center
Danville, PA United States
  Connect »

Carlos Torres, MD

Regional Obstetrical Consultants, PC
Chattanooga, TN United States
  Connect »

Sina Haeri, MD

Austin Maternal Fetal Medicine
Austin, TX United States
  Connect »

Bahaeddine Sibai, MD

UT Health Medical School
Houston, TX United States
  Connect »

Anna Palatnik, MD

Medical College of Wisconsin - Department of Obstetrics & Gynecology
Milwaukee, WI United States
  Connect »

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.