A Multi-center Quasi-experimental Study in Northern Italy to Evaluate the Impact of Sepsis Bundle in Obstetric Settings: the SOS Study

Despite advances in the diagnosis and treatment of sepsis, the studies available in the literature report very high maternal and fetal/neonatal mortality and morbidity in cases of sepsis occurring during pregnancy or the puerperium. It is the third leading cause of maternal death after postpartum hemorrhage and eclamptic syndrome.

Since 2002, the Surviving Sepsis Campaign (SSC) has emphasized the importance of standardized guidelines (sepsis bundles) for the management of sepsis and septic shock in the general population, with the goal of improving patient outcomes. Randomized controlled trials have not produced consistent results regarding the actual impact of sepsis bundles on reducing mortality and morbidity.

There are even fewer studies specifically addressing maternal sepsis.

In May 2018, a Regional Operational Guidance Document for the early identification and management of sepsis in obstetrics was approved and distributed (Decree No. 7691 of 28/05/2018). It contains recommendations addressed to all healthcare facilities in the Lombardy region that have Gynecology and Obstetrics services, as well as to those facilities that, although lacking such services, might still be required to manage pregnancy-related issues.

The purpose of this document is to standardize diagnostic and therapeutic procedures in order to allow early recognition and prompt management, aimed at reducing complications of sepsis in obstetrics, in accordance with the 2016 Surviving Sepsis Campaign guidelines.

Our study aims to evaluate the impact of the aforementioned regional decree on the management of maternal sepsis in the main maternity hospitals in Lombardy.

In particular, we will assess the effect of the decree and its implementation on the length of hospital stay for patients diagnosed with sepsis during pregnancy and the puerperium. Secondary objectives will also include evaluating in-hospital mortality, the number of transfers to the Intensive Care Unit, and the incidence of complications related to the septic event, such as premature rupture of membranes, preterm birth, miscarriage, and fetal or perinatal death.

We will compare two populations of women hospitalized with a diagnosis of sepsis during pregnancy or the puerperium, before and after the approval and dissemination of the regional bundle.

In parallel, we will assess the appropriateness of blood culture requests and observe the incidence of the different microorganisms responsible for the septic event.

Study Overview

• Status: Completed
• Conditions: Sepsis; Sepsis Newborn
• Intervention / Treatment: Other: microbiological results from blood cultures or other materials.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo, SC Malattie Infettive 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

and adult patients discharged with a Hospital Discharge Form reporting the diagnosis of sepsis (or related complications) during pregnancy or the postpartum period hospitalized in the Gynecology and Obstetrics Units of five hospitals in Lombardy.

Description

Inclusion Criteria:

• age 18 or older;
• pregnancy or postpartum;
• patient discharged with a diagnosis of sepsis reported on the Hospital Discharge Form, in accordance with the Surviving Sepsis Campaign guidelines.

Exclusion Criteria:

- no exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
An initial group of women hospitalized between May 1, 2015, and May 1, 2018, before the regional doc	Other: microbiological results from blood cultures or other materials.; Data will be collected regarding outcomes, demographic and clinical characteristics of patients, as well as microbiological results from blood cultures or other materials. The information will be extracted from available electronic or paper hospital medical records.
A second group of women hospitalized from January 1, 2019, to January 1, 2022, following the introdu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of the Regional Guideline Document for the Early Identification and Management of Sepsis in Obstetrics	Evaluate the effectiveness of the Regional Guideline Document for the Early Identification and Management of Sepsis in Obstetrics (Decree No. 7691 of May 28, 2018) in reducing the length of hospital stay of women admitted with a diagnosis of sepsis durin	1 Year

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): August 26, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Neonatal Sepsis; Sepsis
• Other Study ID Numbers: SOS