An Observational Study of Hepatitis C Virus in Pregnancy

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • CTRC Outpatient
  • Children’s Medical Center (Dallas, Plano, Southlake)
  • Parkland Health & Hospital System

Lisa Moseley

Principal Investigator
Brian Casey, M.D.

Official Title

Brief Overview

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


This multi-center observational study examines risk factors for HCV transmission from mother
to baby. The study will also assess risk factors associated with Hepatitis C Virus (HCV)
infection in pregnant women. Also, the study will describe the outcomes of pregnant women
with HCV as well as the outcomes of their infants to 18 months of age.

Approximately 1,800 HCV antibody positive pregnant women and their infants will be followed
from baseline until the infant is 18 months. A randomly selected control cohort of 3,600
pregnant women who are HCV antibody negative will be followed until delivery.

Participant Eligibility

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. 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 Maternal-Fetal Medicine Units (MFMU) Network Cytomegalovirus (CMV)
trial (positive CMV Immunoglobulin M (IgM) and Immunoglobulin G (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 MFMU Network center

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