Immune Globulin, Prophylaxis, Telbuvidine, Vaccine
Conditions
Keywords
Mother-to-child transmission
Brief summary
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.
Detailed description
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.
Interventions
in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B. in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.
Sponsors
Study design
Eligibility
Inclusion criteria
* infants born to HBsAg positive mother HBsAg positive mother
Exclusion criteria
* mothers coinfected HIV or HCV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mother-to-child transmission of HBV | 7 months | HBV infenction in infants at 7 months after birth |