The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection

Capital Medical University

Status: Unknown

Conditions: Chronic Hepatitis B

Treatments: Drug: Tenofovir Disoproxil Fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT03214302

XMLX201706-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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560 participants in 2 patient groups

control group

No Intervention group

Description:

In this group, pregnant women with HBsAg/HBeAg positive and HBV DNA \> 106 copies/ml don not use any antiviral drugs during pregnancy.healthy Pregnant women with HBsAg(-), HBeAg(-)

experimental group

Experimental group

Description:

pregnant women with HBsAg/HBeAg positive and HBV DNA \> 106 copies/ml start to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation and drug withdrawal after delivery immediately, and drug withdrawal in the 6 weeks after delivery.

Treatment:

Drug: Tenofovir Disoproxil Fumarate