Study Goal: to identify risk factors associated with mother to child transmission of HCV

Project Status: Currently Enrolling

Timetable:
Enrollment: October 2012-December 2017

Design Type: Observational Cohort Study

Major Eligibility Criteria:
Singleton pregnancy
An HCV antibody positive screen OR a randomly selected HCV antibody negative screen matched to a case patient by project gestational age +/- 2 weeks and clinical center site
Gestational age at screening no later than 23 weeks 6 days and at enrollment no later than 27 weeks 6 days.

Groups:
Cases: HCV antibody positive
Controls: HCV antibody negative. Two controls per case.

Sample size:
Cases: 1800
Controls: 3600

Scheduled Evaluation/Data Collection:
Maternal Visits @ Baseline (15ml blood), 24-28 weeks gestation (10ml blood), 32-36 weeks gestation (10ml blood), and delivery (10ml maternal blood; 10ml cord blood)

Neonatal data: (blood and saliva @ delivery)
Infant visits @ 2 months (5ml blood) and 18 months (10ml blood)

Primary Outcome: HCV infection of the offspring

For more information, contact Tammy Bishop at 919-668-7475.