An Observational Study of Hepatitis C Virus in Pregnancy
Status: Completed
Location: See all (17) locations...
Study Type: Observational
SUMMARY
This multi-center observational study examines risk factors for HCV transmission from mother to baby.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• Singleton pregnancy
• An HCV antibody positive screen (case) measured using two FDA-approved ELISA tests, the Abbott Architect version 3.0 system and the Ortho HCV 3.0.
• Gestational age at screening no later than 23 weeks and 6 days, and gestational age at enrollment no later than 27 weeks and 6 days, based on clinical information and evaluation of the earliest ultrasound as described below.
Locations
United States
Alabama
University of Alabama - Birmingham
Birmingham
California
Stanford University
Stanford
Colorado
University of Colorado
Denver
Illinois
Northwestern University
Chicago
Massachusetts
Boston Medical Center
Boston
North Carolina
University of North Carolina - Chapel Hill
Chapel Hill
Duke University
Durham
New York
Columbia University
New York
Ohio
Case Western Reserve University
Cleveland
Ohio State University
Columbus
Pennsylvania
University of Pennsylvania
Philadelphia
Magee Women's Hospital of UPMC
Pittsburgh
Rhode Island
Brown University
Providence
Texas
University of Texas Southwestern Medical Center
Dallas
University of Texas - Galveston
Galveston
University of Texas - Houston
Houston
Utah
University of Utah
Salt Lake City
Time Frame
Start Date: 2012-10
Completion Date: 2021-06-30
Participants
Target number of participants: 772
Authors
Related Therapeutic Areas
Sponsors
Leads: The George Washington University Biostatistics Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)