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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023954
• Other study ID #: 262062version2
• Status: Recruiting
• Start date: October 12, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2021
• Source: Cardiff University
• Contact: Simran Sharma, MBBCH
• Phone: 07800885790
• Email: SharmaS44[@]cardiff.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: September 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Sepsis During Labor
• Pregnancy Complications, Infectious
• Sepsis
• SIRS
• Toxemia

Intervention

Diagnostic Test:
• Blood test
Drop of blood for RNA and metabolic analysis

Locations

Country	Name	City	State
United Kingdom	Sir Geraint Evans, Cardiff University	Cardiff

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff University	Cardiff and Vale University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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