A simple, scalable hospital program improved hand hygiene, sped up sepsis treatment, and sharply reduced severe infection outcomes, showing how small, coordinated changes can save mothers’ lives even in resource-limited settings.
Study: A Multicomponent Intervention to Improve Maternal Infection Outcomes. Image credit: Tint Media/Shutterstock.com
A recent study from Africa evaluated the implementation and outcomes of a multifaceted protocol called the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. The report appeared in The New England Journal of Medicine.
Pregnant and recently pregnant women are at risk for severe illness and death due to infection, which accounts for up to half of all maternal deaths in hospitals, especially in low- and middle-income countries. Despite multiple research-based recommendations aimed at reducing infection risk and managing current infection, inconsistent execution and the failure to pick up early signs of maternal infection continue to cause delays in treatment and avoidable deaths.
Why maternal infections matter
Maternal infection in and soon after pregnancy not only pushes up the risk of severe illness and death but is also linked to chronic illness and poor obstetric outcomes. These risks are associated with poor infection control practices. These include failure to adhere to protocols that prevent the transmission of infectious agents; improper antibiotic use; and delayed recognition and treatment of infections and sepsis.
This is especially important when the healthcare system is already burdened by poor staffing, overcrowding with patients, and inadequate supplies of essential resources.
The use of bundled care programs and structured tools has helped detect and treat other obstetric emergencies, bringing about improved outcomes regardless of the available resources. Such bundles are already used to manage sepsis in high-income countries, particularly among non-pregnant patients, showing their broader effectiveness. Conversely, a low-resource bundle to treat maternal sepsis has been developed and piloted, but its clinical benefits for maternal outcomes remain to be established.
The APT-SEPSIS program is meant to overcome these challenges. It presents a multipronged intervention designed to work at the clinic or hospital level. The current study reports its use in a multicountry multicenter randomized controlled trial.
How the program works
The program aimed to identify the benefits of three infection control goals: compliance with hand hygiene, as per World Health Organization (WHO) standards; a broader set of evidence-based protocols to prevent and manage maternal infection (including targeted prophylaxis, proper antiseptic preparation, and treatment of common maternal infections); and early identification of sepsis, with use of the FAST-M bundle (fluids, antibiotics, source control, transfer if required, and monitoring).
This program was implemented in 30 randomly assigned clusters (health facilities) in Malawi and Uganda, with 29 health facilities serving as control groups. The latter received usual care but were informed about all the guidelines underlying the program in the intervention clusters.
Both groups received usual care for six months or more during the baseline phase. This was then followed by a 1:1 random allotment of groups to usual care or the APT-SEPSIS program for one year, with a three-month transition phase that was not included in the outcome analysis.
The program was supported by hospital leaders as well as selected hospital staff who were appointed to be (unpaid) program champions. In addition, the program included training materials, implementation tools, and performance feedback via dashboards for local use, as well as quarterly inspections.
The facilities mostly procured resources via the usual channels. Soap and alcohol-based handrub solutions were provided on an as-needed basis to intervention clusters. Similarly, both groups were given a few thermometers and blood pressure machines if they did not pass the initial readiness assessment for these tools.
Primary outcomes of interest included deaths linked to maternal infection, life-threatening complications where the women ultimately survived, or severe illness related to infection, infection in a body cavity, deep surgical site infection, or deep perineal infection. All participants were currently pregnant or had given birth recently.
How outcomes improved across facilities
During this period, 431,394 women gave birth to live babies, with 190,500 and 240,894 in the baseline (usual care) and intervention phases, respectively.
One or more of the primary outcomes occurred in 1.4 % of patients in the intervention clusters, vs 1.9 % of patients in the usual-care group. Thus, the risk of infection-related outcomes was reduced by 32 % in the intervention group relative to the control group.
This effect was consistent across both countries and all facility types, and it strengthened over time. Rates fell steadily from about 2.4 % at baseline to 2 % in the first month of implementation, reaching 0.9 % by the final month. Likewise, although the early risk in the intervention group matched that of the control group, it decreased by 47 % by the study’s end.
Most of the difference was driven by a reduced number of severe illnesses linked to infection in the intervention group (1.3 %) compared to the control group (1.8 %), representing a 32 % reduction. Infection-related maternal deaths and near-miss events individually showed no clear difference between groups.
Approximately 33 % adherence to hand hygiene was observed in the intervention group, compared to 15 % in the control group. Proper antibiotic prophylaxis was administered before Cesarean section in 74 % of mothers in the intervention group, compared to 58 % in the control group, resulting in a mean difference of 16 %.
Again, early identification and management of infection were superior in the intervention group. For instance, vital signs were recorded at admission in almost half of the patients in the intervention group, compared to 15 % of the controls. Antibiotics were given within an hour of suspected sepsis in 44 % of intervention patients vs 38 % of controls.
The study also notes several limitations, including the absence of microbiological data, potential bias due to outcome assessors being aware of group assignments, and the inability to determine which individual components of the multicomponent program were most responsible for the observed improvements.
Implications for future care
“Implementation of the APT-Sepsis program led to a significantly lower risk” of infection-related outcomes. Covering both government and non-governmental facilities, the trial findings apply to health facilities across the spectrum of obstetric care and pregnancy-related infection. Few additional resources were needed, suggesting their feasibility on a large scale.
Even a modest increase in adherence to all three program goals was associated with clinical benefit throughout, probably because it addressed multiple points of weakness in the sepsis pathway. Incomplete adherence may reflect challenges beyond the program itself, including staffing shortages and too few handwashing stations.
Further work is required to identify outcomes over the longer term, and in other settings and countries, as well as their cost-effectiveness.
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