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

NCT05023954 | Unknown

• 1 other identifier: 262062version2
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Blood test DIAGNOSTIC_TEST

Drop of blood for RNA and metabolic analysis

A; B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant Participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cardiff University: lead
• Cardiff and Vale University Health Board: collaborator

Study Sites (1)

Sir Geraint Evans, Cardiff University

Cardiff, CF14 4ED, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 36115679 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA analysis

MeSH Terms

Conditions

Sepsis; Pregnancy Complications, Infectious

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Peter Ghazal, PHD

  Cardiff University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simran Sharma, MBBCH

CONTACT

07800885790; SharmaS44@cardiff.ac.uk

Summia Zaher, MD

CONTACT

ZaherS@cardiff.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 27, 2021
• Study Start: October 12, 2020
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)