Hepatitis B, Chronic
Conditions
Keywords
Vertical infection transmission, Tenofovir
Brief summary
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.
Interventions
DRUGTenofovir1
receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
DRUGTenofovir2
receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
DRUGTenofovir3
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
DRUGTenofovir4
receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml
Exclusion criteria
* pregnancy patients with HBeAg-negative or HBV-DNA\<106copies /ml
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum | up to 1 year | Check HBV-DNA in serum by ELISA in pregnant women. The measure unit is copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| interferon-γ (IFN-γ) | up to 1 year | the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL |
| Interleukin 4 (IL-4) | up to 1 year | the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL |
| Interleukin 6 (IL-6) | up to 1 year | the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL |
| the concentration of Interleukin 2 (IL-2) | up to 1 year | the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL |
| HBV-DNA of babies | when the baby is 7-month-old | 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. |
| hepatitis B e-antigen (HBeAg) | up to 1 year | check HBeAg in serum of pregnant women.the measure unit is PEIU/mL |
| HBV-DNA in placenta tissue | the date of delivery | Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL. |
| T cell ratio | up to 1 year | T cell ratio in serum is measured by follow cytometry in pregnant women |
Countries
China
Contacts
Primary ContactGuiqin Bai, M.D.;Ph.D.
Outcome results
None listed