Mother-to-child Transmission of HBV in China

Recruiting

• Conditions: Hepatitis B, Chronic; Mother to Child Transmission
• Interventions: Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV

• Registration Number: NCT05172453
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2015-07-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-13
• Last Update Submitted: 2021-12-13
• Study First Posted: 2021-12-29
• Last Update Posted: 2021-12-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nationwide hospital-based cohort	comprehensive management algorithm for preventing mother-to-child transmission of HBV	HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in hospitals nationwide.
Community-based cohort	comprehensive management algorithm for preventing mother-to-child transmission of HBV	HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in Bao' an district, Shenzhen

Primary Outcome Measures

Name	Time	Method
rate of birth defect	5 years	compare rate of birth defect among children born to mothers with and without antiviral therapy during pregnancy
rate of mother-to-child transmission of HBV	5 years	compare rate of mother-to-child transmission of HBV among children born to mothers with and without antiviral therapy during pregnancy

Secondary Outcome Measures

Name	Time	Method
change of HBV DNA level in mothers with antiviral therapy from baseline to withdrawal of antiviral drugs	from enrollment to delivery, assessed up to 40 weeks	compare HBV DNA levels of mothers with antiviral therapy at baseline and after delivery

Trial Locations

Locations (15)

302 military hospital of China; 🇨🇳 Beijing, China

Zhujiang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China

Xixi Hospital of Hangzhou; 🇨🇳 Hangzhou, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, China

Jinlin Hou; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Jilin University; 🇨🇳 Chang chun, China

Fifth Affiliated Hospital of Southern Medical University; 🇨🇳 Guangzhou, China

Beijing YouAn Hospital, Capital Medical University; 🇨🇳 Beijing, China

The First People's Hospital of Foshan; 🇨🇳 Foshan, China

Guangdong Maternal and Child Care Hospital; 🇨🇳 Guangzhou, China

Guangzhou No. 8 People's Hospital; 🇨🇳 Guangzhou, China

Shenzhen Baoan Maternal and Child Care Hospital; 🇨🇳 Shenzhen, China

The Third People's Hospital of Shenzhen; 🇨🇳 Shenzhen, China

Third Hospital of Jiujiang; 🇨🇳 Jiujiang, China

Second Hospital of Nanjing; 🇨🇳 Nanjing, China