APT-Sepsis Program Lowers Severe Infection-Related Maternal Outcomes: NEJM
UK: Researchers have found in a new study that implementation of the APT-Sepsis program significantly reduced the risk of infection-related maternal death, near-miss events, and severe infection-related illness compared with usual care.
Published in the New England Journal of Medicine, the study led by David Lissauer of the Institute of Life Course and Medical Sciences, University of Liverpool, highlights the potential of a structured, evidence-based approach to transform maternal infection outcomes in low-resource settings. Maternal infection and sepsis remain among the leading causes of preventable maternal mortality worldwide, particularly in low- and middle-income countries, where gaps in early detection, adherence to hygiene standards, and consistent treatment often lead to delayed or inadequate care.
To address these challenges, the researchers conducted a cluster-randomized trial assessing the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. This multicomponent intervention aimed to strengthen adherence to World Health Organization hand-hygiene recommendations, promote evidence-based infection-prevention and treatment practices, and encourage early identification and management of sepsis using the FAST-M bundle—fluids, antibiotics, source control, transfer when required, and monitoring.
The trial involved 59 healthcare facilities across Malawi and Uganda, representing more than 431,000 births during the study period. Facilities were assigned either to implement the APT-Sepsis program or to continue with usual care, which included standard guideline dissemination without structured support. The primary endpoint was a composite outcome reflecting the burden of severe maternal infection: infection-related maternal death, infection-related near-miss events, or severe infection-related morbidity, including deep surgical-site, deep perineal, or body-cavity infections.
Key findings were as follows:
- The intervention group showed a lower rate of severe infection outcomes, with 1.4% affected compared to 1.9% in the usual-care group.
- This difference represented a 32% reduction in risk (risk ratio 0.68).
- The benefit of the APT-Sepsis program was consistent across both participating countries.
- The risk reduction was observed in facilities of all sizes.
- The positive effect of the intervention remained stable throughout the duration of the trial.
While the results are encouraging, the authors noted several limitations. Because the intervention included multiple components, it is difficult to determine which specific elements drove the improvement in outcomes. The absence of microbiologic data meant that pathogen identification and resistance trends could not be assessed. Additionally, trial staff were aware of facility assignments, which may introduce bias, although standardized criteria and daily data collection by independent personnel helped minimize this risk. Some post-discharge events may have been underreported, but given the severity of the outcomes, the researchers believe this had minimal impact on the findings.
The study highlights the importance of context-specific implementation strategies. Expanding the APT-Sepsis program to other regions will likely require collaboration with ministries of health to customize training materials and ensure cultural relevance. Further evaluation of provider experiences, behavior change, and cost-effectiveness is also needed.
Overall, the trial provides strong evidence that structured, multicomponent interventions can meaningfully improve maternal infection outcomes, offering a scalable pathway to reducing preventable maternal deaths globally.
Reference:
DOI: 10.1056/NEJMoa2512698
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