Vertical Transmission of Hepatitis C Virus

NCT ID: NCT02044042

Last Updated: 2015-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Hepatitis C Transmission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HCV pregnant women

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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

9 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Lariboisière

OTHER

Sponsor Role lead

Responsible Party

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Stephane Mouly, MD PhD

Professor at University Paris VII Denis Diderot, physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere

Locations

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Hopital Lariboisiere

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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

Role: CONTACT

00 33 149956339

Facility Contacts

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

Role: primary

00 33 149956339

Other Identifiers

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Liver005

Identifier Type: -

Identifier Source: org_study_id

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