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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03539016

SHIELD-01

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.