A Multicomponent Intervention to Improve Maternal Infection Outcomes

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.).

Figure 1. The Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) Intervention

This multi-component intervention enabled healthcare workers to meet 3 goals, with implementation supported by a strategy designed to promote behavioural change. *Healthcare workers should handwash with soap or cleanse with alcohol based handrub their hands: 1) Before touching the woman or newborn, 2) Before a clean or aseptic procedure, 3) After body fluid exposure risk, 4) After touching a woman or newborn, 5) After touching a woman or newborn’s surroundings. Effective technique is required including appropriate glove use. † Use antibiotic prophylaxis in: preterm-prelabour rupture of membranes, manual removal of the placenta, abortion or miscarriage surgery, operative vaginal birth, 3^rd or 4th degree tears and prior to caesarean section. Antibiotic prophylaxis should not be used in: uncomplicated pregnancy or birth, pre-term labour with intact membranes, meconium stained amniotic fluid, episiotomy. Caesarean section: Use antiseptic solution for preparing skin and vagina. ‡ Detect sepsis early: Maternal vital signs measured at least daily. Recorded on colour coded early warning chart. Red flag abnormalities + infection triggers use of the FAST-M bundle. FAST-M bundle: To be completed within 1 hour. Fluids - 500ml crystalloid bolus, repeated if hypotension persists. Antibiotics - According to source or if unknown ceftriaxone 2g IV OD and metronidazole 500mg IV TDS (or 400mg PO TDS) with additional singe dose gentamicin 5mg/kg IV if haemodynamically unstable. Source: Identify and remove/treat the source Transfer: Transfer if required to a different hospital or location that can provide higher level of care. Monitoring: Repeat maternal observation every 30 minutes until stable, neonatal monitoring and review if required.

Figure 2. Patients with the Primary Outcome during the Baseline, Transition and Implementation periods.

The primary outcome was a composite of maternal infection-related mortality or severe morbidity (infection-related maternal near miss, deep surgical or perineal site infection, or body-cavity infection) among pregnant or recently pregnant women. The transition phase, a 3 month period involving training of champions and embedding of the intervention into hospital systems, was not included in the analysis.

Figure 3. Primary Outcome According to Prespecified Subgroups.

Shown are forest plots of the risk ratios for the primary outcome; a composite of maternal infection-related mortality or severe morbidity (infection-related maternal near miss, deep surgical or perineal site infection, or body-cavity infection) among pregnant or recently pregnant women, according to prespecified subgroups. These were country, facility size that was defined by tertile at the point of randomization, within each country and time point in months post randomization. The size of the square represents the relative numbers in each subgroup, with bars representing 95% confidence intervals. The width of the confidence intervals for the subgroup analysis have not been adjusted for multiplicity and cannot be used to infer treatment effects.