A Study of the Interruption on the Mother-to-child Transmission of Hepatitis B Virus （HBV MTCT）in Newborns at High Risk

Study Overview
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Brief Summary
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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
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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.

Official Title
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According to the Venous Blood HBsAg State of Neonatus at Birth, Discussing the Efficiency of Personalized Blocking Method of HBV Maternal-neonatal Transmission in High-risk Newborns

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Biological: 200 IU HBIG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>In this group,these children born in about two hours, we injected HBIG 200 iu and 10 micrograms of hepatitis b vaccine in their left and right thigh respectively, then injected 10 micrograms again in 1 and 6 months. | |
| experimental group<br>In this group,about 2 hours after birth, respectively injecting HBIG 200 IU and 10 micrograms of hepatitis b vaccine in the right and left thigh, and in 1 and 6 months again taking 10 micrograms of standard solution, in addition, offering the additional injection of 200 IU HBIG within 24 hours. | Biological: 200 IU HBIG<br>* additional 200 IU HBIG within 24 hours was used for the experimental group of newborns<br>* Other names: hepatitis B immune globulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blocking rate of vertical transmission of hepatitis B | 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. | seven months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti HBs level at the age of one month and seven months | Observing the level of anti HBs, then discussing the efficiency of personalized blocking method of HBV maternal-neonatal transmission | one month and seven months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis B, mother to child transmission, interruption, hepatitis B immunoglobulin, pregnancy, HBsAg, newborns