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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03539016

Enrollment

1000

Registered

2018-05-29

Start date

2015-07-31

Completion date

2018-05-31

Last updated

2018-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Chronic hepatitis B, Mother-to-child transmission

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

China

Outcome results