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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir1 | 100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one week after delivery. |
| |
| Tenofovir2 | 100 patients receive tenofovir （300mg/d）from (28±2） weeks of pregnancy to one month after delivery. |
| |
| Tenofovir3 | 100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one week after delivery. |
| |
| Tenofovir4 | 100 patients receive tenofovir （300mg/d）from （24±2）weeks of pregnancy to one month after delivery. |
| |
| Group without any treatment | 100 patients don't receive any blockade therapies |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir1 | Drug | receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| deoxyribonucleic 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 | 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 | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| the concentration of Interleukin 2 (IL-2) | the concentration of Interleukin 2 (IL-2)in serum of pregnant women, U/mL | up to 1 year |
| interferon-γ (IFN-γ) | the concentration of interferon-γ (IFN-γ) in serum of pregnant women,U/mL |
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Inclusion Criteria:
Exclusion Criteria:
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pregnant women with HBeAg-positive and HBV-DNA>106copies/ml from the out-patient department of First Affiliated Hospital of Xi'an Jiaotong University
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiqin Bai, M.D.;Ph.D. | Contact | 86-18991232517 | baigq@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Guiqin Bai, M.D.;Ph.D. | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31807036 | Derived | Gao F, Zhang WT, Lin YY, Wang WM, Xu N, Bai GQ. Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study. Infect Drug Resist. 2019 Nov 7;12:3475-3484. doi: 10.2147/IDR.S228982. eCollection 2019. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Blood, placenta tissue of HBeAg-positive pregnant women
| Tenofovir2 | Drug | receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure. |
|
| Tenofovir3 | Drug | receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure. |
|
| Tenofovir4 | Drug | receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure. |
|
| up to 1 year |
| Interleukin 4 (IL-4) | the concentration of Interleukin 4 (IL-4)in serum of pregnant women, U/mL | up to 1 year |
| Interleukin 6 (IL-6) | the concentration of Interleukin 6 (IL-6)in serum of pregnant women,U/mL | up to 1 year |
| T cell ratio | T cell ratio in serum is measured by follow cytometry in pregnant women | 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. | 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 | up to 1 year |
| HBV-DNA in placenta tissue | Check HBV-DNA of placenta tissue by quantitative PCR. The measure unit is copies/mL. | the date of delivery |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |