Clinical trial NCT04805034: Predictive Model for Prognosis of Chronic HBV Infection Mothers
Official title: Predictive Model for Prognosis of E Antigen-positive Mothers With Chronic HBV Infection: A Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: Shaanxi Provincial People's Hospital
name: Baoji Maternal and Child Health Hospital
name: Weinan Central Hospital
name: Ankang Central Hospital
name: Hanzhong Central Hospital
name: Yan'an University Affiliated Hospital
First posted: 2021-03-18
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers with chronic hepatitis B infection

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.


Eligibility criteria: 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

Primary outcomes:
measure: the rate of HBeAg loss
timeFrame: Postpartum 96weeks
measure: the rate of HBeAg seroconversion
timeFrame: Postpartum 96weeks
measure: the rate of HBsAg loss
timeFrame: Postpartum 96weeks
Secondary outcomes:
measure: the rate of undetectable HBV DNA
timeFrame: Postpartum 96weeks
measure: the rate ALT normalization
timeFrame: Postpartum 96weeks
measure: Dynamic changes of serum HBsAg, HBeAg, HBV DNA and HBV RNA titer
timeFrame: at delivery, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks after delivery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Tianyan Chen, phD
role: STUDY_CHAIR
References: