Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants
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)
1 other identifier
observational
1,000
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedMay 29, 2018
April 1, 2018
2.6 years
May 16, 2018
May 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of mother-to-child transmission
Infants from 7 to 12 months of age
Rate of hepatitis flare during pregnancy and postpartum
up to postpartum weeks 6-8
Eligibility Criteria
Pregnant woman
You may qualify if:
- Gestation of 4-32 weeks
- HBsAg+ \> 6 months, HBeAg+/-
- Informed consent signed voluntarily
- Good compliance and able to be followed up as planned
You may not qualify if:
- Coinfection with hepatitis C virus or human immunodeficiency virus;
- 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.;
- Unable or unwilling to use mobile health tools.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Nanfang Hospital
Guangzhou, Guangdong, China
302 military hospital of China
Beijing, China
Beijing YouAn Hospital
Beijing, 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
Guangzhou, China
Jiujiang Maternal and Child Care Service Centre
Jiujiang, China
Third Hospital of Jiujiang
Jiujiang, China
Second Hospital of Nanjing
Nanjing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2018
First Posted
May 29, 2018
Study Start
July 1, 2015
Primary Completion
February 1, 2018
Study Completion
May 1, 2018
Last Updated
May 29, 2018
Record last verified: 2018-04