Clinical trial NCT03214302: The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection
Official title: The Incidence of Postpartum Hepatitis in Pregnant Women With High HBVDNA Loads
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis B
Keywords: antiviral treatment
hepatitis B virus
pregnant woman
Postpartum hepatitis
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 560
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The majority of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level. However, there is no withdrawal time recommendations after childbirth at present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.

Detailed description: Most of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level, and 11.5% of patients with HBV DNA positive would lead to deterioration of liver function. Meanwhile, the highest peak of ALT level could occur in 2 weeks after delivery, then it would dropped to a low point in 4-5 weeks. However, there is no withdrawal time recommendations after childbirth at present.The aim of our study is to investigate the changes of serological indexes, the changing rule of the liver function, hepatitis status, and its correlation with antiviral therapy in pregnant women with HBV infection after delivery, and then explore the withdrawal time of antiviral treatment during pregnancy.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who were chronic hepatitis B and had achieved HBeAg positive and HBV DNA \> 106 copies/ml
* healthy Pregnant women with HBsAg(-), HBeAg(-)

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, HIV, etc.
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
* without gestational hypertension, premature rupture of membranes, antepartum haemorrhage diseases or amniotic fluid piercing history during pregnancy.

Primary outcomes:
measure: The incidence rate of hepatitis flare after drug withdrawal in maternal postpartum
timeFrame: after delivery 24weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan hospital,Capital Medical University
state: Beijing
Study officials:
References:
citation: Li M, Sun F, Bi X, Lin Y, Yang L, Jiang T, Deng W, Lu Y, Zhang L, Yi W, Xie Y. Effects of antiviral therapy and drug withdrawal on postpartum hepatitis in pregnant women with chronic HBV infection. Hepatol Int. 2023 Feb;17(1):42-51. doi: 10.1007/s12072-022-10412-w. Epub 2022 Sep 15.
citation: Wang F, Xie S, Ran C, Hao H, Jiang T, Deng W, Bi X, Lin Y, Yang L, Sun F, Zeng Z, Xie Y, Li M, Yi W. Effect of Antiviral Therapy During Pregnancy on Natural Killer Cells in Pregnant Women With Chronic HBV Infection. Front Immunol. 2022 May 23;13:893628. doi: 10.3389/fimmu.2022.893628. eCollection 2022.