The Active Prevention and Treatment of Maternal Sepsis
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Date
2022-07-13
Authors
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Journal ISSN
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Publisher
Kamuzu University of Health Sciences
Abstract
Hybrid 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,
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APT-Sepsis Protocol
Version 1.0 Date, 13 April 20222.0 Date, 06 June 2022
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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 Findings