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

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ClinicalTrials.gov Identifier: NCT01810835
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière

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.

Condition or disease
Hepatitis B

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.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.
Study Start Date : November 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth [ Time Frame: 9 months of life ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This monocentre, observational study will include pregnant women whom HBV-DNA is > 105 IU/mL and who are not currently treated for HBV hepatitis.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810835


Locations
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France
Hopital Lariboisiere
Paris, France, 75475
Paris, France
Sponsors and Collaborators
Hopital Lariboisière
Investigators
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Principal Investigator: Pierre O Sellier, M.D., Ph.D. Hopital Lariboisiere, Paris, France

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Responsible Party: Stephane Mouly, MD PhD, Professor, Medicine A Department, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT01810835     History of Changes
Other Study ID Numbers: URT-Liver-001
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by Stephane Mouly, MD PhD, Hopital Lariboisière:
HBV mother-to-child transmission
women with HBV DNA > 105 I.U./mL
France
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections