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临床试验/NCT04325542
NCT04325542已完成不适用

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, Germany1 个研究点 分布在 1 个国家目标入组 743 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
743
试验地点
1
主要终点
HBsAG Prevalence

研究概览

简要总结

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.

详细描述

Worldwide, more than 2 billion people are infected with hepatitis B virus (HBV). Of these, 240 million are chronic carriers of HBV and are at risk of death from acute fulminant liver disease, liver cirrhosis or hepatocellular carcinoma (HCC). The World Health Organization (WHO) has stated that the prevalence of hepatitis B is highest in sub-Saharan Africa and East Asia and estimates that between 5-10% of the adult population are chronically infected. Currently, several drugs have been approved in industrialized countries for treating chronic HBV infection and these follow established guidelines from professional medical organizations. Antiviral treatment of chronic hepatitis B infection significantly delays the progression of cirrhosis, reduces the incidence of HCC and improves long-term survival. However, in many resource-constrained settings, including Tanzania, the implementation of this treatment has not yet occurred.

The lack of treatment opportunities in resource-constrained settings means that the prevention of HBV infection is crucial. In countries with high HBV prevalence, most HBV transmission occurs during childhood.

In Tanzania, the prevalence of acute or chronic HBV infection (as defined by a positive hepatitis B surface antigen, HBsAg, test) among blood donors or adults in Dar es Salaam, Tanzania was found to be 8.8% and 6%, respectively. People suffering from chronic HBV have a lifelong risk of developing complications like liver cirrhosis, liver failure or hepatocellular carcinoma (HCC). Chronic hepatitis B infection is the main cause for HCC in Tanzania and there is no therapy available. There are no national recommendations or vaccination program against HBV for HCWs in Tanzania. However, in 2002,Tanzania implemented the WHO policy of general HBV vaccination for children as part of the extended program on immunization (known as EPI). According to notified data, a vaccination coverage of 84% among one year-old children was achieved in 2008 with an immunization schedule of 4, 8, 12 weeks after birth . Above 60% of the infections are acquired in the early childhood by transmission from mother to newborn. This early transmission leads to a chronic Hepatitis B infection among 90% of the infected newborn and, therefore, a vaccination at the earliest 4 weeks after birth might be too late to prevent MTCT. As a matter of fact, in Tanzania, we can estimate 1.4 million chronic Hepatitis B infections through mother-to- child transmission in early phase.

There are two interventions that could prevent MTCT:

  1. Implementation of Hepatitis B Immunoglobulin (HBIg) to the child directly after birth
  2. Active immunization against HBV within 24 hours after birth. The first intervention is very expensive (100€/per child) and is therefore not sustainable for the Tanzanian health system. The second intervention is cheaper and recommended by the WHO.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 years or above.
  • Signed consent form

排除标准

  • Psychiatric disorders

结局指标

主要结局

HBsAG Prevalence

时间窗: Day 1

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

次要结局

未报告次要终点

研究者

发起方
Medical Mission Institute, Germany
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Christa Kasang

Research Coordinator

Medical Mission Institute, Germany

研究点 (1)

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