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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05023954
Enrollment
330
Registered
2021-08-27
Start date
2020-10-12
Completion date
2022-09-01
Last updated
2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Sepsis, Maternal Sepsis During Labor, Pregnancy; Infection, Sepsis, SIRS

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.

Interventions

DIAGNOSTIC_TESTBlood test

Drop of blood for RNA and metabolic analysis

Sponsors

Cardiff and Vale University Health Board
CollaboratorOTHER_GOV
Cardiff University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Positive predictive value of genomic sepsis-test biomarker in identifying participants with confirmed sepsis2 yearsNew genomic sepsis-test biomarker tested to see if it compares to clinically known biomarkers in identifying sepsis

Countries

United Kingdom

Contacts

Primary ContactSimran Sharma, MBBCH
SharmaS44@cardiff.ac.uk07800885790
Backup ContactSummia Zaher, MD
ZaherS@cardiff.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026