Chronic Hepatitis B
Conditions
Keywords
antiviral treatment, hepatitis B virus, pregnant woman, Postpartum hepatitis
Brief summary
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.
Detailed description
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.
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
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml * healthy Pregnant women with HBsAg(-), HBeAg(-)
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 incidence rate of hepatitis flare after drug withdrawal in maternal postpartum | after delivery 24weeks | ALT \> 3 times the upper limit of normal |
Countries
China
Contacts
Primary ContactYao Xie
Outcome results
None listed