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.
- To identify risk factors for mother to child transmission of HCV
- To determine risk factors for HCV seropositivity in pregnant women*
- To determine the seroprevalence of HCV infection in the MFMU Network population
- To determine a threshold of viremia below which mother to child transmission does not occur
- To determine the risk of adverse pregnancy outcome among women seropositive for HCV*
- To describe the natural history of HCV in children infected via mother to child transmission
- To evaluate whether cesarean delivery is protective against mother to child transmission
* This objective is not relevant to the revised protocol, but will be addressed with previously collected data
Study Design Summary
The study is a multi-center observational cohort study of women at participating MFMU Network clinical centers. In addition selected centers of the NICHD International and Domestic Pediatric and Maternal HIV Studies Network will enroll patients into the HCV study. Women who have an HCV antibody positive screen, as determined by the test, before 236 weeks gestation will be eligible to enroll in the study. Approximately 1,200 seropositive viremic and 600 seropositive non-viremic women are expected to be enrolled in the study.
It is estimated that approximately 2,500 women who have an HCV antibody negative screen will be included in the control cohort. At MFMU Network sites, controls will be matched to case cohort patients by clinical center and gestational age +/- two weeks.
Principal Investigator: Michael Varner
Department: Maternal-Fetal Medicine