Protocols

Browse

Recent Submissions

Now showing 1 - 1 of 1
  • Item
    Restricted
    Epidemiology of HBV and HCV among pregnant women at QECH
    (Kamuzu University of Health Sciencies, 16-06-21) Nkhata, Charles; Kalongonda, Milton; Mvula, Memory
    Type of study This will be a descriptive cross sectional study. The problem to be studied Viral Hepatitis is a predominant cause of liver damage worldwide with approximately 1.4million deaths annually. HBV and HCV are common causes of high morbidity and mortality rates worldwide. It is estimated that approximately, 248million people are living with chronic HBV infection and that 110million people are HCV antibody positive. This disease is neglected in developing countries due to lack of proper treatment and screening programs. Unfortunately, infected pregnant women pose a high risk to neonates before or during delivery. Very little is known about the prevalence of these viruses among pregnant women in Malawi. The objectives Broad objective • To assess the epidemiology of Hepatitis B Virus and Hepatitis C Virus among pregnant women at Queen Elizabeth Central Hospital. Specific objectives 1. To determine sero-prevalence of HBsAg and Anti-HCV in pregnant women at Queen Elizabeth Central Hospital 2. To assess risk factors associated with HBV and HCV infection in pregnant women. 3. To determine distribution of HBsAg and Anti-HCV among pregnant women. Methodology The study will be conducted at the antenatal clinic and antenatal ward at Queen Elizabeth Central Hospital. We plan to recruit pregnant women who are willing to take part in the research. Simple random sampling will be used for the women who provide consent to participate in the study. We will the collect blood sample which will be sent to the COM lab for ELISA for HBsAg and Anti- HCV The data will be analyzed using Epi info and SPSS version 22. Association between serological results variables (risk factors) will be established using Chi-square and association will be measured using odds ratio. Expected findings and their dissemination. The study results are expected to uncover the epidemiology of HBV and HCV among pregnant women of different age groups at QECH. We expect to detect low to undetectable levels of HCV as opposed to HBV makers. The results of the study will be disseminated to COMREC, QECH and at the COM Research dissemination conference. A manuscript will also be submitted for publication in peer reviewed journals. 1. INTRODUCTION Viral hepatitis is the predominant cause of liver diseases such as liver fibrosis, cirrhosis and hepatocellular carcinoma in the world (1). There are five types of hepatitis virus(A-E) that cause infection but Hepatitis B virus (HBV) and Hepatitis C virus (HCV) are the most common causes of acute and chronic liver infections. Globally, every year about 1.4 million people die of viral hepatitis (2). Despite its deadliness, the disease is neglected in developing countries due to lack of screening programs and treatment. Therefore, viral hepatitis has become one of the major leading causes of high viral associated mortality and morbidity rates (3). The burden of chronic HBV and HCV remains disproportionately high in Sub-Saharan Africa and 5-15% of the population is chronically infected with HBV followed by HCV. HBV and HCV have common modes of transmission and rarely these viruses can exist together (4). In 2018, HBV sero-prevalence was estimated to be about 8.1% among the Malawian general population and HCV was below 1% (3). HBV is manly contracted at birth from infected mothers and during early childhood whereby those infected develop chronic infections. 90 percent of infants born to infected mothers with chronic hepatitis are at risk of developing chronic HBV later in life. In contrast when HBV is contracted during adulthood, 5-10 percent of adults develop persistent chronic HBV infections (5). HBV is a partially double stranded DNA virus with an icosahedral capsid and envelope. HBV is classified as an ortho-hepadnavirus in the family of hepadnaviridae. HBV resembles a retrovirus replication mode by using an intermediate RNA stage. HBV contains several antigens that can be 16-Jun-2021 3 used as disease makers these include; Hepatitis B surface antigen (HBsAg), Hepatitis B core antigen (HBcAg), Hepatitis B e-antigen (HBeAg) (6). Hepatitis C is a positive sense single stranded RNA virus (+ssRNA) that belong to the genus hepacivirus and is a member of flaviviridae family. In acute infections, HBV invade hepatocytes by binding to the host cellular receptors to enter and replicate in the cells. During incubation period high copies of the virus are present before the host immune response develops and controls the virus. As the virus replicates, HBcAg and HBeAg get expressed on the cytoplasmic membrane which trigger B and T cell response. Damage to hepatocytes is due to antibody dependent, Natural Killer, and Cytotoxic T cell action. HCV pathogenesis is regulated by host immunity and metabolic responses that influence liver function. HCV does not cause cytopathic effect to the hepatocytes rather during replication it causes cell necrosis by several mechanisms including immune mediated cytolysis and other contributing factors such as hepatic steatosis, oxidative stress and insulin resistance (7). Viral hepatitis is caused by different subtypes of Hepatitis viruses for example, HBV and HCV which are considered to be blood borne pathogens. HBV and HCV cause acute hepatitis which can clear spontaneously or progress to chronic hepatitis (8). Chronic hepatitis is also a predominant cause of liver damage, cirrhosis and hepatocellular carcinoma (HCC) in general population globally (3),(9). There are several risk factors that are associated with viral hepatitis transmission, and these include; reuse of needles among individuals and needle stick injuries, blood transfusion, local barbers (10). In other literatures the following have also been known to be risk factors; multiple sexual partners, family history of hepatitis or any other liver diseases, surgery, IV infusion, tooth brush sharing (11). Individuals who are at a high risk of contracting these blood borne infections include; individuals from countries with high prevalence of HBV and HCV or international travelers, recipients of blood and blood products, injecting drug users, patients with liver diseases, health care workers and hemodialysis patients. Several measures have been put in place to control blood borne viral hepatic infections. Treatment against acute hepatitis B has not been developed but limited and non-curative treatment for chronic hepatitis B is available, a combination of lamivudine and alpha-interferon is given to suppress HBV viral load (12). Unlike hepatitis C there is a vaccine for hepatitis B. The vaccine was discovered in 1965 by Dr. Baruch Blumberg and his team (13). The vaccine is administered as an active prophylaxis in three doses; after the first dose, the second dose is given after a month and the third (booster) is administered after six months. In infants, the first dose is administered within 24 hours and the two remaining doses follow a similar pattern as in adults (14). In an exposed individual a passive prophylaxis in form of an intra-muscular injection that contains Hepatitis B immunoglobulin is given within seven days of exposure to offer short-term protection. Other preventive measures like civic education have been put in place by the WHO to minimize risk behaviors among infected population and sensitize risk groups on how to prevent spreading of hepatitis (8). At present it is thought that giving the hepatitis B vaccine to pregnant women is relatively safe(15) in addition, current vaccines contain noninfectious HBsAg and should cause no risk to the fetus(16). 2. JUSTIFICATION Several studies have been conducted in various countries around the world on the epidemiology of HBV and HCV in the general population as well as in pregnant women. Literature shows that viral hepatitis during pregnancy is associated with a high risk of maternal complications, has a high rate of vertical transmission causing fetal and neonatal hepatitis and has been reported as a leading cause of maternal deaths (7). For these reasons, screening antenatal women for hepatitis B surface antigen and Hepatitis C antibody can give a reliable prevalence of these diseases in a population and provide an avenue for preventing mother to child transmission of the viruses. Despite the importance of Hepatitis B and C infections in pregnancy, there is paucity of data on the prevalence of Hepatitis B and C viruses in the pregnant women in Malawi. We therefore feel that this study will contribute to the body of knowledge to bridge this gap 3. OBJECTIVES OF THE STUDY 3.1. BROAD To assess the epidemiology of Hepatitis B Virus and Hepatitis C Virus among pregnant women at Queen Elizabeth Central Hospital. 3.2. SPECIFIC OBJECTIVES 1. To determine sero-prevalence of HBsAg and Anti-HCV in pregnant women at Queen Elizabeth Central Hospital. 2. To assess risk factors associated with HBV and HCV infection in pregnant women. 3. To determine the distribution of HBsAg and Anti-HCV infection among pregnant women of different age groups. 4. METHODOLOGY 4.1. TYPE OF STUDY The study will use prospective and descriptive cross-section study. Prospective analysis will be conducted whereby blood samples will be collected from the pregnant women and tested for HBV and HCV. Descriptive cross sectional study will be used to characterize lab results by looking at their qualitative and quantitative nature. 4.2. STUDY SITE The study will be conducted at QECH in Blantyre and College of Medicine Hematology laboratory. Participants will be recruited at the antenatal clinic and antenatal ward at QECH. Blood samples will be processed at COM Hematology Lab. 4.3. STUDY POPULATION This study will target pregnant women at QECH. 4.4. STUDY PERIOD The study will be conducted within a period of four weeks after approval from COMREC. The planned activities are indicated in the Gantt chart as follows;