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

Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01810835
Enrollment
28
Registered
2013-03-14
Start date
2011-11-30
Completion date
2013-11-30
Last updated
2013-12-06

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

Conditions

Hepatitis B

Keywords

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

Brief summary

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

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.

Interventions

None listed

Sponsors

Hopital Lariboisière
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth9 months of life

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026