NCT01810835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

March 12, 2013

Last Update Submit

December 5, 2013

Conditions

Hepatitis B

Keywords

HBV mother-to-child transmissionwomen with HBV DNA > 105 I.U./mLFrance

Outcome Measures

Primary Outcomes (1)

  • Rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth

    9 months of life

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Lariboisiere

Paris, 75475, France

Location

Unknown Facility

Paris, France

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Pierre O Sellier, M.D., Ph.D.

    Hopital Lariboisiere, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Medicine A Department

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

November 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations

FR(2)