mSEP: Testing of Physiological and Immune-metabolic Blood Markers for Maternal Sepsis

• Conditions: Maternal Sepsis During Labor; SIRS; Maternal Sepsis; Sepsis; Pregnancy; Infection
• Interventions: Diagnostic Test: Blood test

• Registration Number: NCT05023954
• Lead Sponsor: Cardiff University

Brief Summary

A prospective observational cohort study investigating physiological parameters vs biological markers of whole blood in septic and non-septic pregnant woman to predict systemic immune health

Detailed Description

The altered physiology of pregnancy makes the signs and symptoms of sepsis less distinctive in the pregnant population. This can lead to both over treatment (with antibiotics) and late identification of sepsis. The progression of sepsis can be rapid in this population, resulting in severe morbidity and mortality. The mortality associated with sepsis in the general population is over 10%, while septic shock can increase this figure up to 30%. A study looking at maternal mortality due to sepsis recognised that the time from the onset of infection to death was less than 24 hours in 50% of patients. A review of the literature shows that half of the fatal cases of maternal sepsis could have been prevented with early detection of sepsis.

The unmet need is therefore a diagnostic bedside tool that can be performed on women identified as high risk via physiological parameters. The tool needs to be quick and easy to use whilst accurate at diagnosing sepsis.

Study Objectives

To evaluate the effectiveness of physiological parameters in predicting maternal sepsis.

To evaluate the effectiveness of alternative biomarkers in diagnosing maternal sepsis including a genomic sepsis-test.

Investigation of the systemic immune health of women undergoing an uncomplicated pregnancy and labour.

Study Timeline

• Study Start: 2020-10-12
• Status Verified: 2021-08
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-27
• Last Update Posted: 2021-08-27
• Primary Completion: 2022-04-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

Pregnant with viable pregnancy confirmed on ultrasound at dating scan and over 18 years of age Able to provide informed consent (a translation service will be provided for women where English is not the first language);

Women recruited into Cohort B will have deferred consent taken to avoid interference with clinical care.

Exclusion Criteria

• Pregnant woman under the age of 18 or wishing not to consent, withdrawing consent or lacking capacity.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	Blood test	A consecutive collection of data from 100 pregnant women with suspected sepsis Bloods taken for Sepsis Biomarkers including a genomic sepsis-test throughout the sepsis episode
A	Blood test	A longitudinal observational study looking at the pregnancy journey of 200 women Bloods taken for sepsis biomarkers including a genomic sepsis-test throughout the pregnancy journey

Primary Outcome Measures

Name	Time	Method
Positive predictive value of genomic sepsis-test biomarker in identifying participants with confirmed sepsis	2 years	New genomic sepsis-test biomarker tested to see if it compares to clinically known biomarkers in identifying sepsis

Trial Locations

Locations (1)

Sir Geraint Evans, Cardiff University; 🇬🇧 Cardiff, United Kingdom