Mother-to-child Transmission of HBV in China

Hepatitis B, Chronic Clinical Trial

Official title:

A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172453
• Other study ID #: shield project 02
• Status: Recruiting
• Start date: July 1, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinlin Hou
• Phone: +86 13802727354
• Email: jlhousmu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In order to evaluate the feasibility of eliminating mother-to-child transmission (MTCT) of hepatitis B virus (HBV) by 2030, a multi-center, prospective cohorts study was conducted to investigate MTCT of HBV in China.

Description:

A prospective, multicenter study of pregnant women with HBV infection was conducted from July 2015 up to now in a real world setting in the Shield Project stage Ⅱ. Inclusion criteria was any pregnant women with chronic HBV infection. Pregnant women were excluded if they had a positive serologic test for human immunodeficiency virus or hepatitis C virus or any co-morbidity that might reduce compliance or if they were unable or unwilling to use the mobile health application-Shield APP. Enrolled mothers and infants were prospectively followed until infant post-vaccination serologic testing (PVST) was performed at 7-12 months of age.

Demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, HBV serologic marker tests, HBV DNA tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, Apgar score and any major birth defect), breastfeeding and PVST for infants at 7-12 months of age were collected.

A mobile health application called "SHIELD" was developed and used in the Shield Project stage Ⅱ to collect data and provide support for communication between mothers and their doctors. All laboratory test reports, questionnaires and other relevant information was uploaded into SHIELD. Participants could consult with their doctors via SHIELD during the follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pregnant women with chronic HBV infection.

Exclusion Criteria:

• positive serologic test for human immunodeficiency virus or hepatitis C virus;

• any co-morbidity that might reduce compliance;

• unable or unwilling to use the mobile health application-Shield APP

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Mother to Child Transmission

Intervention

Other:
• comprehensive management algorithm for preventing mother-to-child transmission of HBV
To standardize the clinical management of preventing MTCT of HBV and reduce incidences of MTCT, the Chinese Foundation for Hepatitis Prevention and Control (CFHPC) organized experts to compile the "Management algorithm for prevention of mother-to-child transmission of hepatitis B virus" based on the latest research progress and recently published guidelines, which includes 10 steps of pregnancy management and postpartum follow-up, among which screening, antiviral treatment, and infant immunization are its core contents.

Locations

Country	Name	City	State
China	302 military hospital of China	Beijing
China	Beijing YouAn Hospital, Capital Medical University	Beijing
China	The First Affiliated Hospital of Jilin University	Chang chun
China	The First People's Hospital of Foshan	Foshan
China	Fifth Affiliated Hospital of Southern Medical University	Guangzhou
China	Guangdong Maternal and Child Care Hospital	Guangzhou
China	Guangzhou No. 8 People's Hospital	Guangzhou
China	Jinlin Hou	Guangzhou	Guangdong
China	Zhujiang Hospital, Southern Medical University	Guangzhou
China	Xixi Hospital of Hangzhou	Hangzhou
China	Third Hospital of Jiujiang	Jiujiang
China	Second Hospital of Nanjing	Nanjing
China	Shanghai Public Health Clinical Center	Shanghai
China	Shenzhen Baoan Maternal and Child Care Hospital	Shenzhen
China	The Third People's Hospital of Shenzhen	Shenzhen

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Chinese Foundation for Hepatitis Prevention and Control, Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of mother-to-child transmission of HBV	compare rate of mother-to-child transmission of HBV among children born to mothers with and without antiviral therapy during pregnancy	5 years
Primary	rate of birth defect	compare rate of birth defect among children born to mothers with and without antiviral therapy during pregnancy	5 years
Secondary	change of HBV DNA level in mothers with antiviral therapy from baseline to withdrawal of antiviral drugs	compare HBV DNA levels of mothers with antiviral therapy at baseline and after delivery	from enrollment to delivery, assessed up to 40 weeks