Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50000 participants
OBSERVATIONAL
2015-07-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nationwide hospital-based cohort
HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in hospitals nationwide.
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.
Community-based cohort
HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in Bao' an district, Shenzhen
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* any co-morbidity that might reduce compliance;
* unable or unwilling to use the mobile health application-Shield APP
FEMALE
No
Sponsors
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Chinese Foundation for Hepatitis Prevention and Control
UNKNOWN
Tigermed Consulting Co., Ltd
INDUSTRY
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Jinlin Hou
Professor & Director
Principal Investigators
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Jinlin Hou
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Jinlin Hou
Guangzhou, Guangdong, 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
Countries
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Central Contacts
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Facility Contacts
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Jinlin Hou
Role: primary
Zhihua Liu
Role: backup
Mei Wang
Role: primary
Hua Zhang
Role: primary
Jing Jiang
Role: primary
Honglian Bai
Role: primary
Qing Shan
Role: primary
Jianhong Xia
Role: primary
Huiyuan Liu
Role: primary
Xiaozhu Zhong
Role: primary
Chun Zhao
Role: primary
Guojun Shen
Role: primary
Guorong Han
Role: primary
Li Yan
Role: primary
Wei Wang
Role: primary
Yingxia Liu
Role: primary
Other Identifiers
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shield project 02
Identifier Type: -
Identifier Source: org_study_id