500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.
Study Type
OBSERVATIONAL
Enrollment
500
receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGdeoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL
Time frame: up to 1 year
deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
Check HBV-DNA in serum by quantitative PCR in pregnant women. The measure unit is copies/mL
Time frame: up to 1 year
the concentration of Interleukin 2 (IL-2)
the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL
Time frame: up to 1 year
interferon-γ (IFN-γ)
the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL
Time frame: up to 1 year
Interleukin 4 (IL-4)
the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL
Time frame: up to 1 year
Interleukin 6 (IL-6)
the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL
Time frame: up to 1 year
T cell ratio
T cell ratio in serum is measured by follow cytometry in pregnant women
Time frame: up to 1 year
HBV-DNA of babies
Check HBV-DNA by ELISA and quantitative PCR. The measure unit is copies/mL. All babies who used tenofovir will be tested when he is 7-month-old, in order to make sure whether they have infection during pregnant period.
Time frame: when the baby is 7-month-old
hepatitis B e-antigen (HBeAg)
check HBeAg in serum of pregnant women.the measure unit is PEIU/mL
Time frame: up to 1 year
HBV-DNA in placenta tissue
Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL.
Time frame: the date of delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.