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Vertical Transmission of Hepatitis C Virus

H

Hopital Lariboisière

Status

Unknown

Conditions

Hepatitis C
Transmission

Study type

Observational

Funder types

Other

Identifiers

NCT02044042
Liver005

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

9 months to 15 years old

Volunteers

No 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)

Trial design

120 participants in 1 patient group

HCV pregnant women
Description:
HCV chronically infected pregnant women, with a positive HCV RNA during pregnancy

Trial contacts and locations

1

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Central trial contact

Pierre O SELLIER, M.D., Ph.D

Data sourced from clinicaltrials.gov

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