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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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DOI (Published version): 10.1136/bmjopen-2022-066382

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
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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 &gt;99% accuracy for detecting bacterial neonatal sepsis. In this prospective study, we will describe physiological parameters and novel biomarkers in two cohorts&#x2014;healthy pregnant women and pregnant women with suspected sepsis&#x2014;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 &#x2018;booking&#x2019;, 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.</abstract><type>Journal Article</type><journal>BMJ Open</journal><volume>12</volume><journalNumber>9</journalNumber><paginationStart>e066382</paginationStart><paginationEnd/><publisher>BMJ</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2044-6055</issnPrint><issnElectronic>2044-6055</issnElectronic><keywords/><publishedDay>17</publishedDay><publishedMonth>9</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-09-17</publishedDate><doi>10.1136/bmjopen-2022-066382</doi><url/><notes/><college>COLLEGE NANME</college><department>Biomedical Sciences</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>BMS</DepartmentCode><institution>Swansea University</institution><apcterm/><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. 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spelling 2022-11-07T15:01:46.7435348 v2 61692 2022-10-31 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 ff080296775381560053d5e3a6e81745 0000-0001-7767-4060 Luke Davies Luke Davies true false 2022-10-31 BMS 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. Journal Article BMJ Open 12 9 e066382 BMJ 2044-6055 2044-6055 17 9 2022 2022-09-17 10.1136/bmjopen-2022-066382 COLLEGE NANME Biomedical Sciences COLLEGE CODE BMS Swansea University 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). 2022-11-07T15:01:46.7435348 2022-10-31T12:35:55.1053669 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Simran Sharma 0000-0002-6647-9355 1 Summia Zaher 2 Patrícia R S Rodrigues 0000-0003-0768-0013 3 Luke Davies 0000-0001-7767-4060 4 Sarah Edkins 5 Angela Strang 6 Mallinath Chakraborty 0000-0002-1721-6532 7 W John Watkins 8 Robert Andrews 9 Edward Parkinson 10 Nicos Angelopoulos 11 Linda Moet 12 Freya Shepherd 13 Kate Megan Megan Davies 0000-0002-9807-1231 14 Daniel White 15 Shaun Oram 16 Kate Siddall 17 Vikki Keeping 18 Kathryn Simpson 19 Federica Faggian 20 Maryanne Bray 21 Claire Bertorelli 22 Sarah Bell 23 Rachel E Collis 24 James E McLaren 25 Mario Labeta 26 Valerie B O’Donnell 27 Peter Ghazal 28 61692__25677__56ef434092b74e1c955764405ecaca6a.pdf 61692.pdf 2022-11-07T14:59:44.2749971 Output 659781 application/pdf Version of Record true This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license true eng http://creativecommons.org/licenses/by-nc/4.0/
title 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
spellingShingle 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
Luke Davies
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv ff080296775381560053d5e3a6e81745
author_id_fullname_str_mv ff080296775381560053d5e3a6e81745_***_Luke Davies
author Luke Davies
author2 Simran Sharma
Summia Zaher
Patrícia R S Rodrigues
Luke Davies
Sarah Edkins
Angela Strang
Mallinath Chakraborty
W John Watkins
Robert Andrews
Edward Parkinson
Nicos Angelopoulos
Linda Moet
Freya Shepherd
Kate Megan Megan Davies
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
format Journal article
container_title BMJ Open
container_volume 12
container_issue 9
container_start_page e066382
publishDate 2022
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2022-066382
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description 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.
published_date 2022-09-17T04:20:42Z
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