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Completed

NCT Number: NCT01810835

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hopital Lariboisiere, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 9 months of life

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2013
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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