Completed

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

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Blood-Borne Infections+8

+ Communicable Diseases

+ Digestive System Diseases

From 18 to 45 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2011
See protocol details

Summary

Principal SponsorHopital Lariboisière
Last updated: December 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01810835
Principal SponsorHopital Lariboisière
Last updated: December 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis, Viral, HumanInfectionsLiver DiseasesVirus DiseasesHepadnaviridae InfectionsHepatitis B

Criteria

3 inclusion criteria required to participate
Pregnant woman
whom HBV-DNA > 105 IU/mL
whom HBs Ag +
1 exclusion criteria prevent from participating
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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Hopital Lariboisiere

Paris, FranceOpen Hopital Lariboisiere in Google Maps

Paris, France
Completed2 Study Centers