biostudies-literatureUnknownLissauer DWorld Health OrganizationMedical Research CouncilWellcome Trust<h4>Background</h4>Maternal infection and sepsis are major causes of maternal death and severe illness worldwide, particularly in low- and middle-income countries. Inconsistent implementation of evidence-based recommendations for infection prevention and management and delays in detection and treatment of maternal sepsis contribute to the number of preventable deaths.<h4>Methods</h4>We conducted a cluster-randomized trial to assess a multicomponent intervention, the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. This program was designed to support health care providers in achieving three goals: adherence to World Health Organization (WHO) hand-hygiene standards; adoption of evidence-based practices for maternal infection prevention and management; and early detection of sepsis and use of the FAST-M (fluids, antibiotics, source control, transfer if required, and monitoring) treatment bundle. Usual care was provided in the control group, along with dissemination of guidelines. The primary outcome was a composite of infection-related maternal death, infection-related near-miss event (events in which women survived a life-threatening complication), or severe infection-related illness (deep surgical-site, deep perineal, or body-cavity infection) among women who were pregnant or had recently been pregnant.<h4>Results</h4>We randomly assigned 59 health facilities (where 431,394 women gave birth during the trial) in Malawi and Uganda to the intervention group (30 clusters) or the usual-care group (29 clusters). A primary-outcome event occurred in 1.4% of the patients in the intervention group and in 1.9% of those in the usual-care group (risk ratio, 0.68; 95% confidence interval, 0.55 to 0.83; P<0.001). This effect was generally consistent between countries and among facilities of difference sizes and was sustained over time.<h4>Conclusions</h4>Implementation of the APT-Sepsis program led to a significantly lower risk of a composite of infection-related maternal death, infection-related near-miss event, or severe infection-related illness than usual care. (Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.).The New England journal of medicinehttps://www.ebi.ac.uk/biostudies/studies/S-EPMC7618407biostudies-literatureA Multicomponent Intervention to Improve Maternal Infection Outcomes.PMC7618407001MR/V005782/1MRV005782/1Roberts TTwimukye AWilliams ENyondo-Mipando ALMerriel AKommwa EMonk EJMAllegranzi BMartin JChater TDunlop CWhyte SWeeks ALorencatto FMakuluni RWaitt CMkandawire TMalunga AYang LBilesi RGallos IOkwaro PHemming KNanyondo S JMugahi RGamble CWaitt PKachiwaya CRiches JAtkins LMalata ADesmond NBrizuela VCoomarasamy AAyabo TMonahan MBonet MOlaro CLamorde MFaque BDiplas ARosala-Hallas AParry-Smith WMakuta MMusopole OBanda GChitsulo NChapuma CLissauer DNdumu IAbitimo PRylance JAnilkumar ASouza JPGadama LCheshire JBurnside GHawker LSmith RLwasa JMaseko BfalseA Multicomponent Intervention to Improve Maternal Infection Outcomes.<h4>Background</h4>Maternal infection and sepsis are major causes of maternal death and severe illness worldwide, particularly in low- and middle-income countries. Inconsistent implementation of evidence-based recommendations for infection prevention and management and delays in detection and treatment of maternal sepsis contribute to the number of preventable deaths.<h4>Methods</h4>We conducted a cluster-randomized trial to assess a multicomponent intervention, the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. This program was designed to support health care providers in achieving three goals: adherence to World Health Organization (WHO) hand-hygiene standards; adoption of evidence-based practices for maternal infection prevention and management; and early detection of sepsis and use of the FAST-M (fluids, antibiotics, source control, transfer if required, and monitoring) treatment bundle. Usual care was provided in the control group, along with dissemination of guidelines. The primary outcome was a composite of infection-related maternal death, infection-related near-miss event (events in which women survived a life-threatening complication), or severe infection-related illness (deep surgical-site, deep perineal, or body-cavity infection) among women who were pregnant or had recently been pregnant.<h4>Results</h4>We randomly assigned 59 health facilities (where 431,394 women gave birth during the trial) in Malawi and Uganda to the intervention group (30 clusters) or the usual-care group (29 clusters). A primary-outcome event occurred in 1.4% of the patients in the intervention group and in 1.9% of those in the usual-care group (risk ratio, 0.68; 95% confidence interval, 0.55 to 0.83; P<0.001). This effect was generally consistent between countries and among facilities of difference sizes and was sustained over time.<h4>Conclusions</h4>Implementation of the APT-Sepsis program led to a significantly lower risk of a composite of infection-related maternal death, infection-related near-miss event, or severe infection-related illness than usual care. (Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.).2025-01-01T00:00:00Z2025 Nov2026-06-20T03:12:03.264Z2026-06-20T03:10:08.175ZS-EPMC76184074125975410.1056/NEJMoa2512698