{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"submitter":["Lissauer D"],"funding":["World Health Organization","Medical Research Council","Wellcome Trust"],"pubmed_abstract":["<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.)."],"journal":["The New England journal of medicine"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7618407"],"repository":["biostudies-literature"],"pubmed_title":["A Multicomponent Intervention to Improve Maternal Infection Outcomes."],"pmcid":["PMC7618407"],"funding_grant_id":["001","MR/V005782/1","MRV005782/1"],"pubmed_authors":["Roberts T","Twimukye A","Williams E","Nyondo-Mipando AL","Merriel A","Kommwa E","Monk EJM","Allegranzi B","Martin J","Chater T","Dunlop C","Whyte S","Weeks A","Lorencatto F","Makuluni R","Waitt C","Mkandawire T","Malunga A","Yang L","Bilesi R","Gallos I","Okwaro P","Hemming K","Nanyondo S J","Mugahi R","Gamble C","Waitt P","Kachiwaya C","Riches J","Atkins L","Malata A","Desmond N","Brizuela V","Coomarasamy A","Ayabo T","Monahan M","Bonet M","Olaro C","Lamorde M","Faque B","Diplas A","Rosala-Hallas A","Parry-Smith W","Makuta M","Musopole O","Banda G","Chitsulo N","Chapuma C","Lissauer D","Ndumu I","Abitimo P","Rylance J","Anilkumar A","Souza JP","Gadama L","Cheshire J","Burnside G","Hawker L","Smith R","Lwasa J","Maseko B"],"additional_accession":[]},"is_claimable":false,"name":"A Multicomponent Intervention to Improve Maternal Infection Outcomes.","description":"<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.).","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Nov","modification":"2026-06-20T03:12:03.264Z","creation":"2026-06-20T03:10:08.175Z"},"accession":"S-EPMC7618407","cross_references":{"pubmed":["41259754"],"doi":["10.1056/NEJMoa2512698"]}}