Mother-to-child Transmission of HBV in China

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Hepatitis B, Chronic; Mother to Child Transmission

Treatments: Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05172453

shield project 02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

50,000 participants in 2 patient groups

Nationwide hospital-based cohort

Description:

HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in hospitals nationwide.

Treatment:

Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV

Community-based cohort

Description:

HBV-infected mother-infant pairs have been followed from registry to post vaccination serological test (PVST) in Bao' an district, Shenzhen

Treatment:

Other: comprehensive management algorithm for preventing mother-to-child transmission of HBV