Predictive Model for Prognosis of Chronic HBV Infection Mothers

Last updated: August 20, 2021
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT04805034
XJTU1AF-CRF-2020-001
  • Ages 20-45
  • Female

Study 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

Inclusion Criteria:

  • Age 20-45 years old
  • Serum HBsAg positive> 6 months
  • HBeAg positive at delivery
  • Good compliance

Exclusion

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

Study Design

Total Participants: 1600
Study Start date:
April 16, 2021
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Active - Recruiting

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