The Study of Short-range Antiviral Treatment During Pregnancy to Block Mother-to-child Transmission of Hepatitis B Virus and Withdrawal Time

Study Overview
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Brief Summary
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Pregnant women carry high HBV DNA loads before delivery, which is the most important factor leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of HBV MTCT, but security problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

Detailed Description
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HBV MTCT is the important reason to keep high prevalence of chronic HBV infection in China; high HBV DNA loads of Pregnant women before delivery is the most important factor resulting in mother-to-child transmission of HBV, therefore, how to drop HBV DNA levels of pregnant women before delivery to the level that can markedly decrease the rate of HBV MTCT on the base of HBIG combined hepatitis b vaccine injection for newborns, which is the most important method to improve HBV MTCT. Although Nucleoside analogue antiviral treatment during late pregnancy can dramatically reduce the rate of HBV MTCT, security problems of NA treatment during pregnancy has not been demonstrated, On account of the above problems, our study is to investigate the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

Official Title
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The Study of Starting to Use Tenofovir Disoproxil Fumarate(TDF) Antiviral Treatment From the 32 Weeks of Gestation to Block Mother-to-child Transmission of Hepatitis B Virus(HBV MTCT) and Withdrawal Time

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Tenofovir Disoproxil Fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA > 106 copies/ml Exclusion Criteria: Active consumption of alcohol and/or drugs Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc. History of autoimmune hepatitis Psychiatric disease Evidence of neoplastic diseases of the liver without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>In this group, pregnant women with HBsAg/HBeAg positive and HBV DNA > 106 copies/ml don not use any antiviral drugs during pregnancy. | |
| experimental group<br>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 to block mother-to-child transmission of hepatitis B virus. | Drug: Tenofovir Disoproxil Fumarate<br>* Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy<br>* Other names: TDF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the blocking rate of vertical transmission of hepatitis B | At the birth of 7 months, the venous blood serum HBsAg positive was defined as the failure of the interruption of HBV mother-to-child transmission. | seven months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti HBs level at the age of one month and seven months | Observing the level of anti HBs, then discussing the efficiency of personalized blocking method of HBV maternal-neonatal transmission | one month and seven months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiviral treatment, hepatitis B virus, mother-to-child transmission, Tenofovir Disoproxil Fumarate