A Multicomponent Intervention to Improve Maternal Infection Outcomes.

Summary

In a cluster-randomized trial across 59 facilities (431,394 births) in Malawi and Uganda, the APT-Sepsis program reduced a composite of infection-related maternal death, near-miss, or severe infection from 1.9% to 1.4% (risk ratio 0.68, P<0.001). Effects were consistent across contexts and sustained, supporting implementation of WHO-aligned practices and the FAST-M bundle.

Key Findings

• Cluster-RCT across 59 facilities showed a reduction in composite infection-related outcomes from 1.9% to 1.4% (risk ratio 0.68; 95% CI 0.55–0.83; P<0.001).
• The intervention combined WHO hand hygiene, evidence-based practices, and the FAST-M (fluids, antibiotics, source control, transfer, monitoring) bundle.
• Effects were consistent across countries and facility sizes and were sustained over time.

Clinical Implications

Adoption of APT-Sepsis (WHO hand hygiene, evidence-based infection prevention/management, FAST-M) can reduce maternal infection-related morbidity/mortality. Health systems should implement and monitor bundle fidelity at scale.

Limitations

• Potential contamination and varying fidelity across clusters; blinding not feasible.
• Generalizability beyond the two countries and to high-resource settings is uncertain.

Future Directions

Assess cost-effectiveness, implementation fidelity metrics, and adaptation/scale-up in diverse settings; evaluate patient-reported outcomes and neonatal impacts.