Clinical trial NCT05172453: Mother-to-child Transmission of HBV in China
Official title: A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B, Chronic
Mother to Child Transmission
Keywords: hepatitis B
mother-to-child transmission
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Chinese Foundation for Hepatitis Prevention and Control
name: Tigermed Consulting Co., Ltd
First posted: 2021-12-29
Enrollment: 50000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of mother-to-child transmission of HBV
timeFrame: 5 years
measure: rate of birth defect
timeFrame: 5 years
Secondary outcomes:
measure: change of HBV DNA level in mothers with antiviral therapy from baseline to withdrawal of antiviral drugs
timeFrame: from enrollment to delivery, assessed up to 40 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jinlin Hou
state: Guangdong
city: Beijing
country: China
facility: 302 military hospital of China
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
city: Chang chun
country: China
facility: The First Affiliated Hospital of Jilin University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Guangzhou
country: China
facility: Fifth Affiliated Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Guangdong Maternal and Child Care Hospital
city: Guangzhou
country: China
facility: Guangzhou No. 8 People's Hospital
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: Xixi Hospital of Hangzhou
city: Jiujiang
country: China
facility: Third Hospital of Jiujiang
city: Nanjing
country: China
facility: Second Hospital of Nanjing
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shenzhen
country: China
facility: Shenzhen Baoan Maternal and Child Care Hospital
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou
role: PRINCIPAL_INVESTIGATOR
References: