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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- blocking rate of vertical transmission of hepatitis B
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
blocking rate of vertical transmission of hepatitis B
时间窗: 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.
次要结局
- anti HBs level at the age of one month and seven months(one month and seven months)
研究者
Yao Xie
Head of liver diseases center
Beijing Ditan Hospital