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

Hepatitis B, Chronic Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03539016
• Other study ID #: SHIELD-01
• Status: Active, not recruiting
• Start date: July 2015
• Est. completion date: May 2018

Study information

• Verified date: April 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: May 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
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	Nanfang Hospital	Guangzhou	Guangdong
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

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of mother-to-child transmission		Infants from 7 to 12 months of age
Primary	Rate of hepatitis flare during pregnancy and postpartum		up to postpartum weeks 6-8