Predictive Model for Prognosis of E Antigen-positive Mothers With Chronic HBV Infection: A Multicenter Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,600
- Locations
- 1
- Primary Endpoint
- the rate of HBeAg seroconversion
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
the rate of HBeAg seroconversion
Time Frame: Postpartum 96weeks
the rate of HBeAg loss
Time Frame: Postpartum 96weeks
the rate of HBsAg loss
Time Frame: Postpartum 96weeks
Secondary Outcomes
- the rate ALT normalization(Postpartum 96weeks)
- the rate of undetectable HBV DNA(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)