To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.
Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
700
About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun
About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
Time frame: perinatal to 28 weeks after infant delivery
Its efficacy in the reduction of HBV vertical transmission rate
Time frame: perinatal to 28 weeks after infant delivery
Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg
Time frame: perinatal to 28 weeks of postpartum
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