Prevalence of HBV in Pregnant Women Attending Antenatal Care in Tanzania

NCT04325542 | Completed Results

• 1 other identifier: HBVPMTCT
• Study Type: interventional
• Target: 743
• Locations: 1 country
• Sites: 1

Brief 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

Hepatitis B

Keywords

Hepatitis B in pregancy; Hepatitis B vertical transmission; Hepatitis B Tanzania; Hepatitis B

Outcome Measures

Primary Outcomes (1)

• HBsAG Prevalence

  Number of women attending antenatal clinic at the Bugando Medical Center in Mwanza, Tanzania with Hepatitis B surface antigen (HBsAg) rapid test positive result.

  Day 1

Study Arms (1)

HBSAG positive with rapid test

OTHER

Newborns from woman who are positive with HBSAG rapid test got WHO recommended HBV vaccination at birth to avoid HBV transmission

Diagnostic Test: HBSAg (sure screen test)

Interventions

HBSAg (sure screen test) DIAGNOSTIC_TEST

Diagnostic test for Hepatitis B

HBSAG positive with rapid test

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above.
• Signed consent form

You may not qualify if:

• Psychiatric disorders

Sponsors & Collaborators

• Medical Mission Institute, Germany: lead
• Catholic University of Health and Allied Sciences: collaborator

Study Sites (1)

Bugando Medical Center

Mwanza, Tanzania

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr Christa Kasang
• Organization: Medical Mission Institute

christa.kasang@medmissio.de

Study Officials

• Samuel Kalluvya, Prof

  Bugando Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Hepatitis B prevalence study of woman attending antenatal care

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: March 27, 2020
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: February 1, 2018
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Locations

TA (1)