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

NCT ID: NCT03539016

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang Hospital

Guangzhou, Guangdong, China

Site Status

302 military hospital of China

Beijing, , China

Site Status

Beijing YouAn Hospital

Beijing, , China

Site Status

Fifth Affiliated Hospital of Southern Medical University

Guangzhou, , China

Site Status

Guangzhou No. 8 People's Hospital

Guangzhou, , China

Site Status

Third Affiliated Hospital of Southern Medical University

Guangzhou, , China

Site Status

Zhujiang Hospital

Guangzhou, , China

Site Status

Jiujiang Maternal and Child Care Service Centre

Jiujiang, , China

Site Status

Third Hospital of Jiujiang

Jiujiang, , China

Site Status

Second Hospital of Nanjing

Nanjing, , China

Site Status

Countries

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China

Other Identifiers

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SHIELD-01

Identifier Type: -

Identifier Source: org_study_id

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