Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants

May 25, 2018 updated by: Nanfang Hospital of Southern Medical University

Epidemiological Study on Clinical Features of Chronic Hepatitis B Virus Infection During Pregnancy and Hepatitis B Virus Mother-to-child Transmission (Shield Study Phase Ⅰ)

The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China
        • 302 Military Hospital of China
      • Beijing, China
        • Beijing YouAn Hospital
      • Guangzhou, China
        • Fifth Affiliated Hospital of Southern Medical University
      • Guangzhou, China
        • Guangzhou No. 8 People's Hospital
      • Guangzhou, China
        • Third affiliated hospital of southern medical university
      • Guangzhou, China
        • Zhujiang Hospital
      • Jiujiang, China
        • Jiujiang Maternal and Child Care Service Centre
      • Jiujiang, China
        • Third Hospital of Jiujiang
      • Nanjing, China
        • Second Hospital of Nanjing
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nanfang Hospital

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 woman

Description

Inclusion Criteria:

  1. Gestation of 4-32 weeks
  2. HBsAg+ > 6 months, HBeAg+/-
  3. Informed consent signed voluntarily
  4. Good compliance and able to be followed up as planned

Exclusion Criteria:

  1. Coinfection with hepatitis C virus or human immunodeficiency virus;
  2. Comorbidities of other severe conditions that hinder compliance with follow ups and because of that, the subjects are anticipated to be unable to complete the project.;
  3. Unable or unwilling to use mobile health tools.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of mother-to-child transmission
Time Frame: Infants from 7 to 12 months of age
Infants from 7 to 12 months of age
Rate of hepatitis flare during pregnancy and postpartum
Time Frame: up to postpartum weeks 6-8
up to postpartum weeks 6-8

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

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 (Actual)

February 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIELD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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