An Observational Study of Hepatitis C Virus in Pregnancy

Completed

Conditions studied: Hepatitis C

In brief

This multi-center observational study examines risk factors for HCV transmission from mother to baby.

Key facts

Study ID

NCT01959321

Run by

The George Washington University Biostatistics Center

People needed

772

Starts

2012-10-01

Expected to finish

2021-06-30

Last updated by the study team

2024-02-05

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Planned termination of pregnancy
• Known major fetal anomalies or demise
• Intention of the patient or the managing obstetricians for the delivery to be outside a MFMU Network center, unless special provisions are made to insure infant follow-up at two and 18 months of age.
• Participation in this study in a previous pregnancy.
• Unwilling or unable to commit to 18 months of follow-up for HCV positive infants

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Stanford University — Stanford, California, United States
• University of Colorado — Denver, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Columbia University — New York, New York, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Brown University — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Texas - Galveston — Galveston, Texas, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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