Vertical Transmission of Hepatitis C Virus

• Conditions: Hepatitis C; Transmission

• Registration Number: NCT02044042
• Lead Sponsor: Hopital Lariboisière

Brief Summary

Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.

Detailed Description

Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) has been extensively studied, with a risk around 5% (range: 3 to 10%) from chronically infected pregnant women with a positive HCV RNA during pregnancy. Risk factors include: HCV RNA load level, HIV-HCV co-infection, duration of labour, HCV genotype, child gender, and invasive procedures either during pregnancy or at birth. Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) mainly occurs during the last trimester of pregnancy or at birth or around the birth (El-Shabrawi et al., World Journal of Gastroenterology 2013). Currently, using caesarian section to reduce the risk of Hepatitis C Virus (HCV) Mother-To-Child Transmission (MTCT) is still debated and not recommended in International Guidelines (EASL 2012). Spontaneous viral clearance in infected children during childhood seems to occur in 20% of cases, with predisposing genetic factors (Ruiz-Extremera A et al. Hepatology 2011 ; 53 : 1830-1838) but data about this phenomenon are scarse (Rerksuppaphol S et al. J Gastroenterol Hepatol 2004), justifying the study.

Study Timeline

• Study First Submitted: 2014-01-19
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-02
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• HCV chronically infected pregnant women
• with a positive HCV RNA
• who gave birth in the Maternity Department, Lariboisiere Hospital, Paris, France

Exclusion Criteria

• negative HCV RNA during pregnancy
• acute HCV infection during pregnancy (previous negative HCV test during pregnancy)
• MTCT not to be tested (early child death for instance)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCV status in children born from chronically HCV infected pregnant women	up to 10 years (expected average: 5 years)

Secondary Outcome Measures

Name	Time	Method
HCV RNA in children with positive HCV antibodies (Ab)	up to 10 years (expected average: 5 years)

Trial Locations

Locations (1)

Hopital Lariboisiere; 🇫🇷 Paris, France