Clinical Trials Directory

Trials / Completed

CompletedNCT01959321

An Observational Study of Hepatitis C Virus in Pregnancy

Status
Completed
Phase
Study type
Observational
Enrollment
772 (actual)
Sponsor
The George Washington University Biostatistics Center · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

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

Detailed 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 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.

Conditions

Timeline

Start date
2012-10-01
Primary completion
2021-06-30
Completion
2021-06-30
First posted
2013-10-10
Last updated
2024-02-05

Locations

17 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01959321. Inclusion in this directory is not an endorsement.