Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
1800

Summary

Conditions
Hepatitis C
Type
Observational
Design
Observational Model: OtherTime Perspective: Prospective

Participation Requirements

Age
Younger than 125 years
Gender
Only males

Description

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 outc...

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 750 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 500 pregnant women who are HCV antibody negative will be followed until delivery.

Tracking Information

NCT #
NCT01959321
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Andrew Bremer, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Principal Investigator: Rebecca Clifton, PhD The George Washington University Biostatistics Center Study Chair: Mona Prasad, DO, MPH Ohio State University