Hepatitis B, Chronic
Conditions
Brief summary
Pregnancy is a complex and coordinated physiological process. Pregnancy and the postpartum period are associated with unique changes in the immune system that may impact the natural history of autoimmune diseases and immune-mediated infections. In the postpartum period. ALT flares have been reported in 20%-60% of untreated women and were more likely to occur in hepatitis B e antigen (HBeAg)-positive patients. It has been postulated that postpartum ALT flares may arise to rapid immune restitution against hepatitis B virus (HBV) antigens in the liver, when may be a timing of antiviral treatment. A large number of previous studies have focused on studies on the interruption of mother-to-child transmission in women with chronic hepatitis B(CHB), but studies on the prognosis of mothers undergoing pregnancy and delivery are very limited. What are the factors that affect the clearance of HBeAg or HBsAg? What kind of antiviral treatment protocol should be adopted for mothers with CHB? It is not only a problem that needs to be solved urgently in clinical practice, but also can provide some clues for understanding the occurrence and development of HBV infection in women of childbearing age. Overall, this study intends to carry out a multi-center two-way cohort study on E antigen-positive CHB women in 9 hospitals in Shaanxi Province. To observe the dynamic changes of virological parameters in these patients, figure out the factors of the serum HBsAg loss and HBeAg seroconversion, and establish relevant predictive models.
Interventions
OTHERAge, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level
Exposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level
Sponsors
the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Shaanxi Provincial People's Hospital
Baoji Maternal and Child Health Hospital
Weinan Central Hospital
Ankang Central Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 20-45 years old * Serum HBsAg positive\> 6 months * HBeAg positive at delivery * Good compliance
Exclusion criteria
* Women who give birth to stillbirth due to various reasons * Coinfection with HIV,HCV, syphilis or other sexually transmitted diseases * Severe kidney, cardiovascular, lung, nervous system or immune system diseases * Who are taking immunotherapy drugs or anti-tumor drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of HBeAg loss | Postpartum 96weeks |
| the rate of HBeAg seroconversion | Postpartum 96weeks |
| the rate of HBsAg loss | Postpartum 96weeks |
Secondary
| Measure | Time frame |
|---|---|
| the rate of undetectable HBV DNA | Postpartum 96weeks |
| the rate ALT normalization | Postpartum 96weeks |
| Dynamic changes of serum HBsAg, HBeAg, HBV DNA and HBV RNA titer | at delivery, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks after delivery |
Countries
China
Contacts
Primary ContactTianyan Chen, phD
Backup ContactNaijuan Yao, phD
Outcome results
None listed