NCT03214302

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

The Incidence of Postpartum Hepatitis in Pregnant Women With High HBVDNA Loads

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Beijing Ditan Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2017-07-11
• Last updated: 2017-07-13

Locations

1 site across 1 country: China