CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 743 enrolled
Drug / intervention
HBSAg (sure screen test)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04325542
NCT04325542N/ACompleted

Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania A Survey on the Prevalence of HBsAg in Pregnant Women in the Region of Mwanza, Tanzania

Medical Mission Institute, Germany·interventional·Posted Mar 27, 2020·Updated Oct 26, 2020

In Brief

A clinical study evaluating HBSAg (sure screen test) for Hepatitis B. Completed, enrolled 743 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesTanzania

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 27, 2020
Enrollment StartOct 1, 2014
Primary CompletionMar 1, 2015
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.3 years ago

Interventions

HBSAg (sure screen test)other

Diagnostic test for Hepatitis B