Predictive Model for Prognosis of Chronic HBV Infection Mothers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-16

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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HBeAg positive/HBsAg positive

Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level

Intervention Type OTHER

Exposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level

HBeAg seroconversion /HBsAg loss

Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level

Intervention Type OTHER

Exposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No