Chronic Hepatitis B
Conditions
Keywords
chronic hepatitis B, mother to child transmission, interruption, hepatitis B immunoglobulin, pregnancy, HBsAg, newborns
Brief summary
Chronic hepatitis B (CHB) is a serious liver disease worldwide，HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China. Intrapartum infection is the main period of neonatal HBV infection. Injecting HBIG and hepatitis b vaccine immediately after birth is the most important method of blocking mother-to-child transmission of HBV. However, regular doses of HBIG combined with hepatitis b vaccine blocking measures still have a failure rate as high as 5% \ 15%.There are numerous studies to explore pregnancy women with HBV positive, especially high viral load of those women during pregnancy being treated with nucleoside analogs to increase the blocking rate of HBV MTCT, but there is still a failure rate of 2.2% to 18%. In this study, we will explore the efficiency of personalized blocking method of HBV maternal-neonatal transmission in high-risk newborns,according to the venous blood HBsAg state of neonatus at birth.
Detailed description
In this trial, the study population were consisted of patients suffering from chronic hepatitis B who had achieved HBeAg positive and HBV DNA \> 106 copies/ml and their newborns who were born with HBsAg positive. Before injecting hepatitis b vaccine and HBIG for newborns, we tested their vein blood HBsAg levels, and the venous blood HBsAg positive newborns were randomly divided into the control group and the interventional group in which group we injected the additional 200 IU HBIG within 24 hours after birth, in addition to routine injection. We gathered the neonatal venous blood of 0, 7 and 30 days to test the level of anti HBs, HBsAg and HBV DNA., then detected the level of anti HBs, HBsAg and HBV DNA when these children were seven months.According to the venous blood HBsAg state of neonatus at birth, exploring the efficiency of personalized blocking method of HBV MTCT in high-risk newborns.
Interventions
BIOLOGICAL200 IU HBIG
additional 200 IU HBIG within 24 hours was used for the experimental group of newborns
Sponsors
Beijing Ditan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml * At birth the neonatal venous blood HBsAg positive
Exclusion criteria
* Active consumption of alcohol and/or drugs * Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc. * History of autoimmune hepatitis * Psychiatric disease * Evidence of neoplastic diseases of the liver * without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blocking rate of vertical transmission of hepatitis B | seven months | At the birth of 7 months, the venous blood serum HBsAg positive was defined as the failure of the interruption of HBV mother-to-child transmission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti HBs level at the age of one month and seven months | one month and seven months | Observing the level of anti HBs, then discussing the efficiency of personalized blocking method of HBV maternal-neonatal transmission |
Countries
China
Contacts
Primary ContactYao Xie, MD
Outcome results
None listed