Case-control Study of Antiviral Therapy During Entire and the Third Trimester of Pregnancy in Preventing MTCT of HBV in Mothers With High Serum HBV DNA Load
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 主要终点
- mother-to-child transmission of HBV
研究概览
简要总结
Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg positive mothers with high serum HBV DNA loads.
详细描述
This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis( injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a HBsAg positive mother with high HBV DNA load before delivery, and based on standard immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ) infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA negative receive standard immunoprophylaxis.
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
- — 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants born to HBsAg positive mother HBsAg positive mother
排除标准
- •mothers coinfected HIV or HCV
研究组 & 干预措施
telbivudine treated entire pregnancy
mothers in this group were treated with antiviral therapy during entire pregnancy for hepatitis, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.
干预措施: telbivudine (Drug)
telbivudine treated in late pregnancy
mothers with high serum HBV DNA load were treated with antiviral therapy in late pregnancy, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV.
干预措施: telbivudine (Drug)
结局指标
主要结局
mother-to-child transmission of HBV
时间窗: 7 months
HBV infenction in infants at 7 months after birth
次要结局
未报告次要终点
研究者
Wei Yi
The department of obstetrics and gynecology
Beijing Ditan Hospital