Predictive Model for Prognosis of Chronic HBV Infection Mothers

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.

Conditions

• Hepatitis B, Chronic

Interventions

OTHER

Age, 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 & Collaborators

• the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Northwest Women's and Children's Hospital, Xi'an, Shaanxi

  collaborator OTHER

• Shaanxi Provincial People's Hospital

  collaborator OTHER

• Baoji Maternal and Child Health Hospital

  collaborator UNKNOWN

• Weinan Central Hospital

  collaborator OTHER

• Ankang Central Hospital

  collaborator OTHER

• Hanzhong Central Hospital

  collaborator OTHER

• Yan'an University Affiliated Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  lead OTHER

Principal Investigators

• Tianyan Chen, phD · First Affiliated Hospital Xi'an Jiaotong University

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-16

Primary Completion

2024-01-31

Completion

2024-01-31

Countries

• China

Study Locations