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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

Simran Sharma Orcid Logo, Summia Zaher, Patrícia R S Rodrigues Orcid Logo, Luke Davies Orcid Logo, Sarah Edkins, Angela Strang, Mallinath Chakraborty Orcid Logo, W John Watkins, Robert Andrews, Edward Parkinson, Nicos Angelopoulos, Linda Moet, Freya Shepherd, Kate Megan Megan Davies Orcid Logo, Daniel White, Shaun Oram, Kate Siddall, Vikki Keeping, Kathryn Simpson, Federica Faggian, Maryanne Bray, Claire Bertorelli, Sarah Bell, Rachel E Collis, James E McLaren, Mario Labeta, Valerie B O’Donnell, Peter Ghazal

BMJ Open, Volume: 12, Issue: 9, Start page: e066382

Swansea University Author: Luke Davies Orcid Logo

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Abstract

Introduction Maternal sepsis remains a leading cause of death in pregnancy. Physiological adaptations to pregnancy obscure early signs of sepsis and can result in delays in recognition and treatment. Identifying biomarkers that can reliably diagnose sepsis will reduce morbidity and mortality and ant...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2022
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa61692
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Abstract: Introduction Maternal sepsis remains a leading cause of death in pregnancy. Physiological adaptations to pregnancy obscure early signs of sepsis and can result in delays in recognition and treatment. Identifying biomarkers that can reliably diagnose sepsis will reduce morbidity and mortality and antibiotic overuse. We have previously identified an immune-metabolic biomarker network comprising three pathways with a >99% accuracy for detecting bacterial neonatal sepsis. In this prospective study, we will describe physiological parameters and novel biomarkers in two cohorts—healthy pregnant women and pregnant women with suspected sepsis—with the aim of mapping pathophysiological drivers and evaluating predictive biomarkers for diagnosing maternal sepsis.Methods and analysis Women aged over 18 with an ultrasound-confirmed pregnancy will be recruited to a pilot and two main study cohorts. The pilot will involve blood sample collection from 30 pregnant women undergoing an elective caesarean section. Cohort A will follow 100 healthy pregnant women throughout their pregnancy journey, with collection of blood samples from participants at routine time points in their pregnancy: week 12 ‘booking’, week 28 and during labour. Cohort B will follow 100 pregnant women who present with suspected sepsis in pregnancy or labour and will have at least two blood samples taken during their care pathway. Study blood samples will be collected during routine clinical blood sampling. Detailed medical history and physiological parameters at the time of blood sampling will be recorded, along with the results of routine biochemical tests, including C reactive protein, lactate and white blood cell count. In addition, study blood samples will be processed and analysed for transcriptomic, lipidomic and metabolomic analyses and both qualitative and functional immunophenotyping.Ethics and dissemination Ethical approval has been obtained from the Wales Research Ethics Committee 2 (SPON1752-19, 30 October 2019).Trial registration number NCT05023954.
College: Faculty of Medicine, Health and Life Sciences
Funders: This project is funded by the Welsh Government and the European Regional Development Fund (Ser Cymru Grant Programme: 80762-CU-106) awarded to PG for Project Sepsis. Clinical research time (midwifery and medical) is funded by the Cardiff and Vale Health Board and a grant awarded by the National Institute of Academic Anaesthesia (NIAA19R103).
Issue: 9
Start Page: e066382