Mother-to-child Transmission of HBV in China
A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China
1 other identifier
observational
50,000
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 29, 2021
December 1, 2021
10 years
December 1, 2021
December 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
rate of birth defect
compare rate of birth defect among children born to mothers with and without antiviral therapy during pregnancy
5 years
Secondary Outcomes (1)
change of HBV DNA level in mothers with antiviral therapy from baseline to withdrawal of antiviral drugs
from enrollment to delivery, assessed up to 40 weeks
Study Arms (2)
Nationwide hospital-based cohort
HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in hospitals nationwide.
Community-based cohort
HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in Bao' an district, Shenzhen
Interventions
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.
Eligibility Criteria
Pregnant women with HBV infection in more than 100 hospitals covering 31 regions in China from Jul 2015 to Jun 2021 were enrolled as hospital-based cohort. In addition, pregnant women with HBV infection in Baoan district of Shenzhen, China from Jun 2017 to Dec 2019 were enrolled as community-based cohort.
You may qualify if:
- pregnant women with chronic HBV infection.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Jinlin Hou
Guangzhou, Guangdong, 510515, China
302 military hospital of China
Beijing, China
Beijing YouAn Hospital, Capital Medical University
Beijing, China
The First Affiliated Hospital of Jilin University
Changchun, 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
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, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinlin Hou
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Director
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 29, 2021
Study Start
July 1, 2015
Primary Completion
June 30, 2025
Study Completion
December 31, 2025
Last Updated
December 29, 2021
Record last verified: 2021-12