Sepsis NewbornNCT07375108
A Multi-center Quasi-experimental Study in Northern Italy to Evaluate the Impact of Sepsis Bundle in Obstetric Settings: the SOS Study
An observational study of Sepsis Newborn and Sepsis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sepsis Newborn, Sepsis
- What is being tested?
- microbiological results from blood cultures or other materials.
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 25 Aug 2021to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SC Malattie Infettive 1
Pavia, Pavia, 27100
About this 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.
Read more
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.
- Conditions
- Sepsis Newborn, Sepsis
- Being tested
- microbiological results from blood cultures or other materials.
- Medical subject headings
- Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiological results from blood cultures or other materials.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| An initial group of women hospitalized between May 1, 2015, and May 1, 2018, before the regional doc | Not described Receives: Other: microbiological results from blood cultures or other materials. | |
| A second group of women hospitalized from January 1, 2019, to January 1, 2022, following the introdu | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start25 Aug 2021
- Primary completion26 Aug 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis NewbornStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raffaele Bruno, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375108
- Sponsor's protocol ID
- SOS
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Quasi-experimental Study in Northern Italy to Evaluate the Impact of Sepsis Bundle in Obstetric Settings: the SOS Study
- ClinicalTrials.gov ID
- NCT07375108
- Acronym / sponsor ID
- SOS
- Conditions
- Sepsis Newborn, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| A second group of women hospitalized from January 1, 2019, to January 1, 2022, following the introdu | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | An initial group of women hospitalized between May 1, 2015, and May 1, 2018, before the regional doc |
Primary outcome
Evaluate the effectiveness of the Regional Guideline Document for the Early Identification and Management of Sepsis in Obstetrics
Time frame: 1 Year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Newborn and Sepsis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of the Regional Guideline Document for the Early Identification and Management of Sepsis in Obstetrics (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.