Vertical Transmission of Hepatitis C Virus

Mother-To-Child Transmission (MTCT) of Hepatitis C Virus and Spontaneous Viral Clearance in Infected Children: a Retrospective Study.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02044042

Enrollment

120

Registered

2014-01-23

Start date

2014-10-31

Completion date

2016-07-31

Last updated

2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Transmission

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to 15 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

Primary ContactPierre O SELLIER, M.D., Ph.D

pierre.sellier@lrb.aphp.fr00 33 149956339

Outcome results