Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-10 @ 10:40 PM
Study NCT ID:
NCT01810835
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2013-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.
Sponsor:
Hopital Lariboisière
Organization:
Study Overview
Official Title:
Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: