Maternal Antiviral Treatment and Infants Immunoprophylaxis in the Prevention of Mother-to-child Transmission
Maternal Nucleos(t)Ide Analogue Use and Infants Immunoprophylaxis to Eliminate Hepatitis B Infection in the Real World Setting
1 other identifier
observational
233
1 country
1
Brief Summary
The effective control of nucleos(t)ide analogues for patients infected with hepatitis B has significantly curbed the horizontal transmission of hepatitis B. However, the vertical transmission remains a serious threat to public health for directly increasing the burden of hepatitis B worldwide with the transmission rate up to 80 to 90% among high HBV DNA level if untreated. Currently, the effective prevention of mother-to-child transmission is credited to the implement of HBV vaccination and hepatitis B virus immunoglobin. To leave nobody behind, a growing body of evidence has been yielded to support the use of nucleos(t)ide analogues in the mothers during the late pregnancy. However, the clinical practice can be more complex. Therefore, investigators aim to assess the effectiveness of maternal antiviral therapy and different infants immunoprophylaxis strategy in the prevention of chronic hepatitis infection among children whose mothers were infected with chronic hepatitis B infection in the real world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2018
CompletedFirst Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedJune 12, 2019
June 1, 2019
8 years
June 5, 2019
June 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of children who developed chronic HBV infection between the treatment group and two control groups in the real-world setting.
We compare the proportion of children with chronic HBV born to mothers from three groups in the real life setting
December, 2018
Secondary Outcomes (4)
the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the standardized immunoprophylaxis strategy
December, 2018
the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the aggressive immunoprophylaxis strategy
December, 2018
The proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood
At delivery
The HBV DNA level of mothers among three groups
Within one week before delivery.
Study Arms (3)
The treatment group
Pregnant women with high HBV DNA level \> 2\*10\^6 IU/ml who agree to receive the antiviral treatment during the late pregnancy.
The control group with high HBV DNA level
Pregnant women with high HBV DNA level \> 2\*10\^6 IU/ml who decline to receive the antiviral treatment during the late pregnancy.
The control group with low HBV DNA level
Pregnant women with high HBV DNA level \< 2\*10\^6 IU/ml
Interventions
Pregnant women in this group agree to receive nucleos(t)ide analogue (tenofovir or telbivudine) daily from the 28 weeks of pregnancy to delivery.
Eligibility Criteria
In the real-world setting, we recruited consecutively HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy. Patients were excluded from participation if they had been treated with antiviral drugs during pregnancy. Additional exclusion criteria were drug hypersensitivity, abnormal renal laboratory results, coinfection with human immunodeficiency virus or other human hepatitis viruses.
You may qualify if:
- HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy
You may not qualify if:
- women treated with antiviral drugs during pregnancy.
- drug hypersensitivity;
- abnormal renal laboratory results;
- coinfection with human immunodeficiency virus or other human hepatitis viruses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (1)
The First People's Hospital of Taicang
Suzhou, Jiangsu, 215400, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yonglan Pu
The First People's Hospital of Taicang
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Division of Infectious Diseases
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 6, 2019
Study Start
January 1, 2011
Primary Completion
December 30, 2018
Study Completion
December 30, 2018
Last Updated
June 12, 2019
Record last verified: 2019-06