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| Name | Class |
|---|---|
| Chinese Foundation for Hepatitis Prevention and Control | UNKNOWN |
| Tigermed Consulting Co., Ltd | INDUSTRY |
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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 â…¡. 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 â…¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comprehensive management algorithm for preventing mother-to-child transmission of HBV | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
To investigate mother-to-child transmission, only pregnant women were included.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinlin Hou | Contact | +86 13802727354 | jlhousmu@163.com | |
| Zhihua Liu | Contact | +8618665000386 | zhihualiu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinlin Hou | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinlin Hou | Recruiting | Guangzhou | Guangdong | 510515 | China |
Currently, there is no such plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| 302 military hospital of China | Recruiting | Beijing | China |
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| Beijing YouAn Hospital, Capital Medical University | Recruiting | Beijing | China |
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| The First Affiliated Hospital of Jilin University | Recruiting | Changchun | China |
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| The First People's Hospital of Foshan | Recruiting | Foshan | China |
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| Fifth Affiliated Hospital of Southern Medical University | Recruiting | Guangzhou | China |
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| Guangdong Maternal and Child Care Hospital | Recruiting | Guangzhou | China |
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| Guangzhou No. 8 People's Hospital | Recruiting | Guangzhou | China |
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| Zhujiang Hospital, Southern Medical University | Recruiting | Guangzhou | China |
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| Xixi Hospital of Hangzhou | Recruiting | Hangzhou | China |
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| Third Hospital of Jiujiang | Recruiting | Jiujiang | China |
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| Second Hospital of Nanjing | Recruiting | Nanjing | China |
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| Shanghai Public Health Clinical Center | Recruiting | Shanghai | China |
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| Shenzhen Baoan Maternal and Child Care Hospital | Recruiting | Shenzhen | China |
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| The Third People's Hospital of Shenzhen | Recruiting | Shenzhen | China |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |