The Active Prevention and Treatment of Maternal Sepsis

dc.contributor.authorGadama, Luis
dc.date.accessioned2022-08-18T10:27:15Z
dc.date.available2022-08-18T10:27:15Z
dc.date.issued2022-07-13
dc.description.abstractHybrid implementation/effectiveness trial. Multi-country, parallel cluster randomised trial with baseline phase. Setting 32 healthcare facilities in Malawi will participate, as part of a multi-country study The problem Maternal infections and sepsis are reported to cause 11% of direct maternal deaths (1), and recently the WHO GLOSS (Global maternal Sepsis) study, although based on small numbers, Formatted: Font: Bold 13-Jul-2022 x APT-Sepsis Protocol Version 1.0 Date, 13 April 20222.0 Date, 06 June 2022 Formatted: Left suggests maternal infection may contribute to over half of all intra-hospital maternal deaths (2), with by far the greatest burden borne by women in Low- and Middle-Income Countries (LMICs). There is an urgent need to identify ways to combat this problem which are implementable at scale, and are clinically effective, cost effective and sustainable. This study which will be conducted in Malawi aims at assessing the effectiveness of implementing APTSepsis bundle which is the quality of care for mothers, and adherence to WHO evidence-based practices in infection prevention and management. APT- Sepsis is a carefully developed programme designed specifically to be used in countries and facilities where there are limited resources available; Malawi and Uganda are the countries identified to participate in this study. It APT-Sepsis aims to change health care workers’ behaviours to ensure mothers get the best care possible to better prevent and manage infections. Broad Objective The broad objective of this study is to examine if the APT-Sepsis programme is effective at reducing infection related maternal mortality and severe maternal morbidity, at any time prior to discharge infrom health care facilities in Malawi and Uganda. Specific Objectives The specific objectives are, to evaluate if the APT-Sepsis programme is effective at reducing secondary clinical outcomes of sStillbirth, early neonatal death, maternal mortality, maternal near miss; to explore differential or subgroup effects of the APT-Sepsis programme; to understand the implementation of the APT-Sepsis programme in Malawi, to facilitate interpretation of trial outcomes and development of a longer-term implementation strategy; and finally to determine if the APT-Sepsis programme is cost effective. Methods The study is a multi-country, parallel cluster randomised trial with a baseline control phase. There is an integrated implementation evaluation and health economic evaluation. The overall trial will include 630 clusters in Malawi and Uganda, each of which is a health facility. This protocol specifies the activities to be conducted in Malawi. During the first six months each cluster will continue with their current practices and data will be collected to establish weekly rates of maternal infection and mortality. After the baseline period, the clusters will be randomly allocated in a 1:1 ratio to the APT-Sepsis programme or current practice with passive guideline dissemination, using a minimisation algorithm. The intervention seeks to change the behaviours of health care providers to improve adherence to WHO guidelines and best practice in infection prevention and management, and detection and management of maternal sepsis. Expected Findingsen_US
dc.description.sponsorshipUK Foreign,Commonwealth and Development Office, the UK Medical Research Council (MRC), The UK Department of Health and Social Care through the National Institute of Health Research (NIHR) and Wellcomeen_US
dc.identifier.urihttp://rscarchive.kuhes.ac.mw/handle/20.500.12988/1071
dc.publisherKamuzu University of Health Sciencesen_US
dc.relation.ispartofseriesP.05/22/3635;
dc.titleThe Active Prevention and Treatment of Maternal Sepsisen_US
dc.typePlan or blueprinten_US
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