Chronic Hepatitis B
Conditions
Keywords
antiviral treatment, hepatitis B virus, mother-to-child transmission, Tenofovir Disoproxil Fumarate
Brief summary
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
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).
Interventions
DRUGTenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy
Sponsors
Beijing Ditan Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the blocking rate of vertical transmission of hepatitis B | seven months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti HBs level at the age of one month and seven months | one month and seven months | Observing the level of anti HBs, then discussing the efficiency of personalized blocking method of HBV maternal-neonatal transmission |
Countries
China
Contacts
Primary ContactYao Xie
Outcome results
None listed