Mother-to-child Transmission of HBV in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Real World, Multi-center Study on Mother-to-child Transmission of Hepatitis B Virus in China

Conditions
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Hepatitis B, Chronic, Mother to Child Transmission

Intervention / Treatment
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* Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nationwide hospital-based cohort<br>HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in hospitals nationwide. | Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV<br>* 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.<br>|
| Community-based cohort<br>HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in Bao' an district, Shenzhen | Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B, mother-to-child transmission