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

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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; SIRS; Pregnancy; Infection; Maternal Sepsis During Labor; Maternal Sepsis
• Intervention / Treatment: Diagnostic test: Blood test

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 Type: Observational
• Enrollment (Anticipated): 330

Contacts and Locations

• Study Contact: Name: Simran Sharma, MBBCH; Phone Number: 07800885790; Email: SharmaS44@cardiff.ac.uk
• Study Contact Backup: Name: Summia Zaher, MD; Email: ZaherS@cardiff.ac.uk

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF14 4ED
    • Recruiting
    • Sir Geraint Evans, Cardiff University
    • Contact: Angela Strang, PM; Phone Number: 02920745534; Email: StrangA@cardiff.acuk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women attending University Hospital of Wales Cardiff for their pregnancy care

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; 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	Diagnostic test: Blood test; Drop of blood for RNA and metabolic analysis
B; 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	Diagnostic test: Blood test; Drop of blood for RNA and metabolic analysis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cardiff University
• Collaborators: Cardiff and Vale University Health Board
• Investigators: Principal Investigator: Peter Ghazal, PHD, Cardiff University

Publications and helpful links

General Publications

• Sharma S, Zaher S, Rodrigues PRS, Davies LC, Edkins S, Strang A, Chakraborty M, Watkins WJ, Andrews R, Parkinson E, Angelopoulos N, Moet L, Shepherd F, Davies KMM, White D, Oram S, Siddall K, Keeping V, Simpson K, Faggian F, Bray M, Bertorelli C, Bell S, Collis RE, McLaren JE, Labeta M, O'Donnell VB, Ghazal P. mSep: investigating physiological and immune-metabolic biomarkers in septic and healthy pregnant women to predict feto-maternal immune health - a prospective observational cohort study protocol. BMJ Open. 2022 Sep 17;12(9):e066382. doi: 10.1136/bmjopen-2022-066382.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pregnancy Complications; Sepsis; Toxemia; Pregnancy Complications, Infectious
• Other Study ID Numbers: 262062version2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No