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

Nanfang Hospital, Southern Medical University1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Hepatitis B, Chronic

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (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

Outcomes

Primary Outcomes

Rate of mother-to-child transmission

Time frame: Infants from 7 to 12 months of age

Rate of hepatitis flare during pregnancy and postpartum

Time frame: up to postpartum weeks 6-8

Data from ClinicalTrials.gov

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