Investigating the Association of Severe Maternal Infections and Malaria in Two Malaria-Endemic Districts of Malawi: A Mixed Methods Implementation Science Study (Protocol)

Type of Research Study: This is a proposed mixed-methods study that aims to investigate the burden of malaria among severe maternal infections in pregnant and recently pregnant women residing in malaria-hyperendemic districts of Malawi. Furthermore, the study seeks to develop an integrated intervention to enhance the prevention and management of co-infections during pregnancy. Problem: Severe maternal infections, caused by the invasion of pathogenic microorganisms, can progress to life-threatening conditions such as sepsis. Malaria, a severe parasitic systemic infection, remains a major public health challenge, particularly in sub-Saharan Africa, where pregnant women are disproportionately affected. In Malawi, infections account for 22.9% of maternal mortality, yet the specific etiological contributions, including the role of malaria, remain poorly understood. Notably, despite the implementation of preventive measures such as bed nets and intermittent preventive treatment in pregnancy (IPTp), malaria among pregnant women persists, contributing to adverse maternal and fetal outcomes. Mwanza District Hospital, a malaria-endemic region, reports high rates of severe maternal infections (similar malaria diurnal variation pattern), contrasting with Chikwawa District Hospital, which shows lower rates, highlighting the need to investigate the interaction between malaria and severe maternal infections in these settings. Objectives Broad objective To investigate the association between malaria and severe maternal infections among pregnant and recently pregnant women, and to inform the development of an integrated intervention for prevention and management in Malawi. We aim to: Specific objectives 1. To assess the prevalence and pattern of co-infections including malaria among severe maternal infection cases 2. To identify contextual factors associated with the reduced incidence of severe maternal infections. 3. To co-create a context-informed theoretical framework for integrated malaria prevention and treatment in pregnant and recently pregnant women. Methodology • Study Design: Mixed-methods study, specifically a Case-control study(ambidirectional) and a qualitative study • Study Place: The case control study will take place at Mwanza District Hospital; whilst the qualitative at Chikwawa District Hospital. • Study Population: For the case control study pregnant or postpartum women at Mwanza District Hospital are the study population and for the qualitative key stakeholders in the care and management of malaria in pregnancy. • Sample Size: The sample size calculation of the case control study is based on a significance level of 5% and 80% power, estimated 71 cases and 213 controls (1:3 ratio), with proportions of P₁ = 0.349 and P₀ = 0.15. For the qualitative component, a sample size of 98 participants was determined. • Study Period: Nine months, including data collection, data analysis, and report writing, and dissemination. Expected Findings and Dissemination • Expected Findings: The study is expected to provide a comprehensive understanding of the burden and associated factors of malaria among severe maternal infection cases at Mwanza District Hospital and develop a hypothesised program theory for preventing and managing malaria. • Dissemination: Results will be shared at the departmental level, the College of Medicine Ethics Committee, local and international conferences, and submitted for publication in a reputable International Journal.