A feasibility study of intrapartum GBS testing to guide antibiotic prophylaxis in Malawi

Msefula, Chisomo

A feasibility study of intrapartum GBS testing to guide antibiotic prophylaxis in Malawi

Date

2021-06-16

Authors

Msefula, Chisomo

Publisher

Kamuzu University of Health Sciences

Abstract

Trial Type: Prospective clinical feasibility study Problem: As global child mortality falls, deaths in the first 28 days of life are responsible for a growing proportion of childhood deaths. Infection with Streptococcus agalactiae (Group B Streptococcus; GBS) is recognised as an important cause of meningitis, early onset sepsis and late onset sepsis in neonates. In Malawi, GBS is the most frequently isolated organism detected amongst ill neonates and mortality in those infected with GBS is high. There is a need for a rapid and accurate molecular diagnostic test to detect GBS during labour, so that at-risk pregnant women are identified early enough for effective antibiotic prophylaxis to be used before delivery. Aims and objectives: The aim of the project is to evaluate the feasibility of using the LAMP assay to detect and treat Group B Streptoccci amongst pregnant women in Labour in QECH. Specific of objectives of the study are: I. Determine the proportion of GBS positive women using the LAMP assay, presenting at QECH Labor ward II. Determine the proportion of GBS positive women receiving IAP <4hrs before delivery and any associated adverse events III. Identify logistical factors necessary for routine implementation of the LAMP assay for GBS colonization screening Methodology: This study will be carried out in the Labor ward at Queen Elizabeth Central Hospital. The study population will include all women in active labor, at a gestational age greater than 34 weeks, and the sample size will be 3200. A recto-vaginal swab will be taken at admission and tested for GBS positivity using a molecular diagnostic test (LAMP). If GBS positive, IAP will be administered to the woman prior to delivery and cord blood will be taken upon delivery of the baby. Expected Results and Dissemination: We expect the LAMP assay will be easily implemented by the nurses and help identify women colonized with GBS. The work will likely lead to practical and high-impact clinical interventions to improve child health in Malawi. Results from the study will be presented at local and international conferences and also published in peer-reviewed journals.