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A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China
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.
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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
July 1, 2015
Primary Completion Date
June 30, 2025
Completion Date
December 31, 2025
Last Updated
December 29, 2021
50,000
ESTIMATED participants
comprehensive management algorithm for preventing mother-to-child transmission of HBV
OTHER
Lead Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
NCT04166266
NCT06550622
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05922306