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Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania

NCT04325542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 743

Last updated 2020-10-26

Study results available
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Summary

Chronic Hepatitis B virus (HBV) infection is a neglected disease with devastating consequences, particularly in countries with limited resources for the health sector. Mother-to-child-transmission (MTCT) is responsible for around 50 % of the HBV infections in Tanzania which, in 90 % of the cases, lead to a chronic HBV infection of the child. This infection rate could be reduced with an active immunization directly after birth which is recommended by the World Health Organization (WHO). However, the Tanzanian national immunization programme schedules the first Hepatitis B vaccination for the fourth week after birth which is too late to prevent a perinatal transmission.

The aim of the study is to determine the prevalence of Hepatitis B surface antigen (HBsAg) in pregnant women in rural and urban study sites in the region of Mwanza, Tanzania. The blood from the positive -testing mothers should be further examined for viral load, genotype of the virus and for liver transaminases in order to conceive a better understanding of the progression of the infection. Beside the laboratory parameters, risk factors for the infection should be determined with the use of a questionnaire.

Furthermore we would like to assess the number of children who were already infected, during the intrauterine period or during birth.

Conditions

Interventions

DIAGNOSTIC_TEST

HBSAg (sure screen test)

Diagnostic test for Hepatitis B

Sponsors & Collaborators

  • Catholic University of Health and Allied Sciences

    collaborator OTHER

  • Medical Mission Institute, Germany

    lead OTHER

Principal Investigators

  • Samuel Kalluvya, Prof · Bugando Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2015-03-01
Completion
2018-02-01

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325542 on ClinicalTrials.gov