Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.

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

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-11-30

Brief Summary

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The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was \< 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads \> 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.

Detailed Description

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This monocentre, observational study will include pregnant women whom HBV-DNA is \> 105 IU/mL. HBV MTCT rates will be evaluated, according to the level of HBV-DNA in the women during the last three months of pregnancy and at childbirth (between 105 and 108 IU/mL, or \> 108 IU/mL), and according to the clinical practices of serovaccination in the participating center. The evaluation will be based on the rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth. The rate of detectable HBV-DNA will be also evaluated in infants at the same date.

Conditions

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Hepatitis B

Keywords

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HBV mother-to-child transmission women with HBV DNA > 105 I.U./mL France

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman
* whom HBs Ag +
* whom HBV-DNA \>105 IU/mL

Exclusion Criteria

* Women who have to be treated for HBV hepatitis, (AST/ALT \>2 ULN without any explanation, liver biopsy performed before pregnancy showing hepatitis requiring initiation of treatment)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Stephane Mouly, MD PhD

Professor, Medicine A Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre O Sellier, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hopital Lariboisiere, Paris, France

Locations

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Hopital Lariboisiere

Paris, , France

Site Status

Paris, , France

Site Status

Countries

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France

Other Identifiers

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URT-Liver-001

Identifier Type: -

Identifier Source: org_study_id