Mother-to-child Transmission of HBV in China

December 13, 2021 updated by: Jinlin Hou, Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • 302 Military Hospital of China
        • Contact:
          • Mei Wang
      • Beijing, China
        • Recruiting
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
          • Hua Zhang
      • Chang chun, China
        • Recruiting
        • The first Affiliated Hospital of Jilin University
        • Contact:
          • Jing Jiang
      • Foshan, China
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
          • Honglian Bai
      • Guangzhou, China
        • Recruiting
        • Guangdong Maternal and Child Care Hospital
        • Contact:
          • Jianhong Xia
      • Guangzhou, China
        • Recruiting
        • Fifth Affiliated Hospital of Southern Medical University
        • Contact:
          • Qing Shan
      • Guangzhou, China
        • Recruiting
        • Guangzhou No. 8 People's Hospital
        • Contact:
          • Huiyuan Liu
      • Guangzhou, China
        • Recruiting
        • Zhujiang Hospital, Southern Medical University
        • Contact:
          • Xiaozhu Zhong
      • Hangzhou, China
        • Recruiting
        • Xixi hospital of Hangzhou
        • Contact:
          • Chun Zhao
      • Jiujiang, China
        • Recruiting
        • Third Hospital of Jiujiang
        • Contact:
          • Guojun Shen
      • Nanjing, China
        • Recruiting
        • Second Hospital of Nanjing
        • Contact:
          • Guorong Han
      • Shanghai, China
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
          • Li Yan
      • Shenzhen, China
        • Recruiting
        • Shenzhen Baoan Maternal and Child Care Hospital
      • Shenzhen, China
        • Recruiting
        • The Third People's Hospital of Shenzhen
        • Contact:
          • Yingxia Liu
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Jinlin Hou
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nationwide hospital-based cohort
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
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.
Community-based cohort
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of mother-to-child transmission of HBV
Time Frame: 5 years
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
Time Frame: 5 years
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
Time Frame: from enrollment to delivery, assessed up to 40 weeks
compare HBV DNA levels of mothers with antiviral therapy at baseline and after delivery
from enrollment to delivery, assessed up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Tigermed Consulting Co., Ltd
Chinese Foundation for Hepatitis Prevention and Control

Investigators

  • Principal Investigator: Jinlin Hou, Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • shield project 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Currently, there is no such plan to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B, Chronic

Clinical Trials on comprehensive management algorithm for preventing mother-to-child transmission of HBV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe