Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT03539016
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1000
Inclusion Criteria
- Gestation of 4-32 weeks
- HBsAg+ > 6 months, HBeAg+/-
- Informed consent signed voluntarily
- Good compliance and able to be followed up as planned
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Beijing YouAn Hospital
π¨π³Beijing, China
Zhujiang Hospital
π¨π³Guangzhou, China
Fifth Affiliated Hospital of Southern Medical University
π¨π³Guangzhou, China
Nanfang Hospital
π¨π³Guangzhou, Guangdong, China
Jiujiang Maternal and Child Care Service Centre
π¨π³Jiujiang, China
Third Affiliated Hospital of Southern Medical University
π¨π³Guangzhou, China
Third Hospital of Jiujiang
π¨π³Jiujiang, China
Second Hospital of Nanjing
π¨π³Nanjing, China
302 military hospital of China
π¨π³Beijing, China
Guangzhou No. 8 People's Hospital
π¨π³Guangzhou, China