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The majority of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level. However, there is no withdrawal time recommendations after childbirth at present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.
Most of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level, and 11.5% of patients with HBV DNA positive would lead to deterioration of liver function. Meanwhile, the highest peak of ALT level could occur in 2 weeks after delivery, then it would dropped to a low point in 4-5 weeks. However, there is no withdrawal time recommendations after childbirth at present.The aim of our study is to investigate the changes of serological indexes, the changing rule of the liver function, hepatitis status, and its correlation with antiviral therapy in pregnant women with HBV infection after delivery, and then explore the withdrawal time of antiviral treatment during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | In this group, pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml don not use any antiviral drugs during pregnancy.healthy Pregnant women with HBsAg(-), HBeAg(-) | |
| experimental group | Experimental | pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation and drug withdrawal after delivery immediately, and drug withdrawal in the 6 weeks after delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate | Drug | Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum | ALT > 3 times the upper limit of normal | after delivery 24weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Xie | Contact | 8610-84322489 | xieyao00120184@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36109430 | Derived | Li M, Sun F, Bi X, Lin Y, Yang L, Jiang T, Deng W, Lu Y, Zhang L, Yi W, Xie Y. Effects of antiviral therapy and drug withdrawal on postpartum hepatitis in pregnant women with chronic HBV infection. Hepatol Int. 2023 Feb;17(1):42-51. doi: 10.1007/s12072-022-10412-w. Epub 2022 Sep 15. | |
| 35677040 | Derived | Wang F, Xie S, Ran C, Hao H, Jiang T, Deng W, Bi X, Lin Y, Yang L, Sun F, Zeng Z, Xie Y, Li M, Yi W. Effect of Antiviral Therapy During Pregnancy on Natural Killer Cells in Pregnant Women With Chronic HBV Infection. Front Immunol. 2022 May 23;13:893628. doi: 10.3389/fimmu.2022.893628. eCollection 2022. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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|
| 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |