Multicomponent Maternal Sepsis Program Lowers Infection Events
Key Takeaways
- The APT-Sepsis program was associated with a lower rate of the primary composite maternal infection outcome than usual care.
- The reported effect was generally similar across both countries and facility sizes and was described as sustained over time.
- Implementation measures improved, but adherence remained incomplete and the multicomponent design did not isolate the contribution of individual elements.
The trial randomized 59 comprehensive obstetric care facilities in Malawi and Uganda, with 30 assigned to the intervention and 29 to usual care. Across those sites, 431,394 women had live births during the trial, and eligible facilities had at least 1500 births per year with basic readiness requirements such as water and electricity. The design included a baseline control phase for all sites, a 3-month transition period excluded from effectiveness analyses, and then a 12-month intervention phase. APT-Sepsis aimed to improve hand hygiene, evidence-based infection prevention and management, and early sepsis detection and treatment with FAST-M. Usual care included passive guideline dissemination, while intervention sites also received training, tools, dashboards, site visits, and some soap or alcohol-based hand rub when needed.
The primary composite outcome was infection-related maternal death, infection-related near-miss event, or severe infection-related illness during pregnancy, childbirth, or within 42 days after pregnancy ended or up to 28 days after discharge, whichever occurred first, irrespective of birth outcome. During the intervention phase, events occurred in 1752 of 124,298 women with live births in the intervention group, or 1.4%, and in 2208 of 116,596 women with live births in usual care, or 1.9%. The reported risk ratio was 0.68, with a 95% confidence interval of 0.55 to 0.83 and P<0.001. Results were generally consistent across countries and facility sizes and were described as sustained over time. Severe infection-related illness occurred in 1.3% versus 1.8%, with a risk ratio of 0.68 and a 95% confidence interval of 0.55 to 0.84.
Operational measures also improved in the intervention group, although uptake was not complete. Hand-hygiene adherence was 33% versus 15%, with a mean difference of 14 percentage points and a 95% confidence interval of 10 to 19. Appropriate antibiotic prophylaxis before cesarean section was 74% versus 58%, with a mean difference of 15 points and a 95% confidence interval of 4 to 26, while complete recording of vital signs at admission was 48% versus 15%, with a mean difference of 32 points and a 95% confidence interval of 25 to 40. Among patients with suspected sepsis, antibiotics within 1 hour were 44% versus 38%, with a mean difference of 8 points and a 95% confidence interval of negative 3 to 19, indicating measurable but incomplete implementation gains.
The investigators noted that the intervention was multicomponent, so the observed benefit could not be assigned to any single element. Trial staff who identified outcomes were aware of group assignments, post-discharge ascertainment may have missed some events, although the authors noted this was unlikely given the serious nature of these outcomes, and microbiologic data were unavailable. Delivery was further shaped by staffing shortages, inadequate sinks, and limited antibiotic availability, and the NEJM article said extension to other settings may require ministry partnership and local adaptation, with further work needed on experience, behavior change, and cost-effectiveness.
In these Malawi and Uganda facilities, the program was associated with fewer infection-related maternal events while implementation remained constrained by local health system realities.