HCV in Pregnancy


Status: Recruiting
Keywords: Hepatitis C and pregnancy , HCV
IRB Number: 00059147
Specialty: Women and Children's Health
Sub Specialties:

Brief Summary

Approximately 3.2 million persons in the U.S are estimated to have chronic Hepatitis C Virus (HCV) infection.1 Chronic HCV infection may result in chronic liver disease, cirrhosis of the liver or, more rarely, death due to the consequences of chronic liver infection.

It is known that almost all cases of pediatric HCV are the result of transmission of the HCV infection from mother to baby. Studies suggest that the prevalence of HCV infection in pregnancy ranges from 0.6% to 2.4%. Several European studies suggest that the rate of mother to child transmission of HCV is 5% to 10%. However, it is unclear what percentage of these children will spontaneously clear the infection and what percentage will have persistent HCV infection. While maternal co-infection of HIV has emerged as a significant risk factor, study results regarding other possible risk factors associated with mother to child transmission have been mixed.

The purpose of this study is to understand risk factors associated with mother to child transmission of HCV.

Principal Investigator: Michael Varner
Department: Maternal-Fetal Medicine
Co Investigator:

Contact Information

Name:Amber Sowles
Phone: 801-585-5499
Email: amber.sowles@hsc.utah.edu

Inclusion Criteria

1. Singleton pregnancy

2. An HCV antibody positive screen (case) OR a randomly selected HCV antibody negative screen (control) matched to a case patient by project gestational age (see below) +/- 2 weeks and clinical center site. HCV antibody screen will be measured using two FDA-approved ELISA tests,  the Abbott Architect version 3.0 system and the Ortho HCV 3.0.

3. Gestational age at screening no later than 236 weeks and gestational age at enrollment no later than 276 weeks, based on clinical information and evaluation of the earliest ultrasound as described below.

Exclusion Criteria

1. Eligible for the CMV trial (positive CMV IgM and IgG with low avidity) or potentially eligible (positive IgM, negative IgG)

2. Planned termination of pregnancy

3. Known major fetal anomalies or demise

4. Intention of the patient or the managing obstetricians for the delivery to be outside a participating Network center

5.  Participation in this study in a previous pregnancy. 

6. For the case cohort only: unwilling or unable to commit to 18 months of follow-up for HCV positive infants