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1. 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

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

Subjects
Medicine
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.

Published
2022
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2. Pregnancy and neonatal outcomes of COVID-19: The PAN-COVID study

Author

E. Mullins, A. Perry, J. Banerjee, J. Townson, D. Grozeva, R. Milton, N. Kirby, R. Playle, T. Bourne, C. Lees, Abby Rand, Aethele Khunda, Aleš Roztočil, Alexandra J Kermack, Ami Mackay, Amit Verma, Amna Ahmed, Amy Mahdi, Anam Fayadh, Andrea Dall'Asta, Andrea Harrington, Angeliki Gerede, Avideah Nejad, Barkha Sinha, Beth Peers, Bev Hammond, Bini Ajay, Caroline Dixon, Caroline Everden, Carrie Heal, Catherine Bressington, Cheryl Wyatt, Chris Flood, Christine Möller-Christensen, Clare O'Brien, Coralie Glenn-Sansum, Coralie Huson, Dimitrios Rallis, Donna Perkins, Donna Southam, Donna Wixted, Alexandra Viner, Anila Asghar, Antony Nicoll, Caroline Knight, Gillian McKeown, Hema Divakar, Plastiras Panagiotis Christofidis, Prakash Satodia, Rachel Liebling, Rita Arya, Rukhsana Kousar, Ruta Gada, Sankara Narayanan, Stamatina Iliodromiti, Vibha Giri, Vimal Vasu, Wassim Hassan, Zoe Woodward, E. Mutema, Eleanor MK Jarvie, Elena Romero, Emma Collins, Emma Meadows, Emma Mills, Emma Tanton, Enxhi Vrapi, Ernawati Darmawan, Fabio Barra, Federico Prefumo, Fidelma Lee, Hayley L. Martin, Helen Gbinigie, Helen Millward, Hilary Owen, Isobel Crawford, Jacqueline Tipper, Jacqui Jennings, Jamie-Louise Raven, Jane Cantliffe, Jane Radford, Janet Cresswell, Jennifer Syson, Jessie Brain, Joanna Mead, Jude Mossop, Julie Goddard, Julie Grindey, Karen Cloherty, Karen Watkins, Kate Robinson, Katie Barker, Kerry Elliott, Kim Hinshaw, Kirsty Revell, Laura Camarasa, Laura Harris, Laurie Windsor, Leanne Sherris, Lianne Chapman, Linda Bishop, Liona Chiu Yee POON, Lisa Frankland, Liz Glyn-Jones, Louise Emmet, Louise Swaminathan, M.I Aldika Akbar, Maggie Armstrong, Mahalakshmi Gorti, Mairead Black, Mani Malarselvi, Manjiri Khare, Mark Chester, Martina Andrasova, Maryanne Bray, Mauro Parra-Cordero, MD Roland Berger, Michelle Anderson, Millicent Anim-Somuah, Mingxing XIE, Miriam Bourke, Mohamed Elbahnasawy, Mohamed Sobhy Bakry, Ahmar Shah, BA RATHER, David Churchill, Ling Wee, Salman Kidwai, Trevor Balling, Allison Amin, Sandra Essien, Ms Sameena Kausar, Ms.Jyothi Rajeswary, Muglu Javaid, Narendra Aladangady, Neil Shah, Nichola Bale, Nicky Mason, Pensée Wu, Lavinia Margarit, Rabia Zill-e-Huma, Rachel Newport, Robin Hughes, Roobin Jokhi, Roshni Mansfield, Ru Davies, Ruth Davies, Sam Ratcliffe, Sandra Greer, Sarah Coxon, Sarah Ekladios, Sarah Stables, Shanteela McCooty, Sharon Gowans, Sharon Jones, Shazia Jaleel, Shelly Higgins, Sherry Halawa, Siân C Harrington, Sophie Robinson, Soum Nallapeta, Stephanie Grigsby, Susara Blunden, SSA Tiziana Frusca, Veerareddy Sukrutha, Vicki Atkinson, Victoria Murtha, Waldo Germán Caro, Zoe Garner, and Medical Research Council (MRC)

Subjects
SARS-CoV-2, Fetal growth restriction, Infant, Newborn, Pregnancy Outcome, COVID-19, Infant, Obstetrics and Gynecology, Perinatal, Stillbirth, Fetal, Pre-Eclampsia, Reproductive Medicine, Pregnancy, Neonatal, Humans, Premature Birth, 1114 Paediatrics and Reproductive Medicine, Eclampsia, Female, Prospective Studies, Pregnancy Complications, Infectious, Infection, Obstetrics & Reproductive Medicine, PAN-COVID Investigators, COVID
Abstract

OBJECTIVE: To assess perinatal outcomes for pregnancies affected by suspected or confirmed SARS-CoV-2 infection. METHODS: Prospective, web-based registry. Pregnant women were invited to participate if they had suspected or confirmed SARS-CoV-2 infection between 1st January 2020 and 31st March 2021 to assess the impact of infection on maternal and perinatal outcomes including miscarriage, stillbirth, fetal growth restriction, pre-term birth and transmission to the infant. RESULTS: Between April 2020 and March 2021, the study recruited 8239 participants who had suspected or confirmed SARs-CoV-2 infection episodes in pregnancy between January 2020 and March 2021. Maternal death affected 14/8197 (0.2%) participants, 176/8187 (2.2%) of participants required ventilatory support. Pre-eclampsia affected 389/8189 (4.8%) participants, eclampsia was reported in 40/ 8024 (0.5%) of all participants. Stillbirth affected 35/8187 (0.4 %) participants. In participants delivering within 2 weeks of delivery 21/2686 (0.8 %) were affected by stillbirth compared with 8/4596 (0.2 %) delivering ≥ 2 weeks after infection (95 % CI 0.3-1.0). SGA affected 744/7696 (9.3 %) of livebirths, FGR affected 360/8175 (4.4 %) of all pregnancies. Pre-term birth occurred in 922/8066 (11.5%), the majority of these were indicated pre-term births, 220/7987 (2.8%) participants experienced spontaneous pre-term births. Early neonatal deaths affected 11/8050 livebirths. Of all neonates, 80/7993 (1.0%) tested positive for SARS-CoV-2. CONCLUSIONS: Infection was associated with indicated pre-term birth, most commonly for fetal compromise. The overall proportions of women affected by SGA and FGR were not higher than expected, however there was the proportion affected by stillbirth in participants delivering within 2 weeks of infection was significantly higher than those delivering ≥ 2 weeks after infection. We suggest that clinicians' threshold for delivery should be low if there are concerns with fetal movements or fetal heart rate monitoring in the time around infection. The proportion affected by pre-eclampsia amongst participants was not higher than would be expected, although we report a higher than expected proportion affected by eclampsia. There appears to be no effect on birthweight or congenital malformations in women affected by SARS-CoV-2 infection in pregnancy and neonatal infection is uncommon. This study reflects a population with a range of infection severity for SARS-COV-2 in pregnancy, generalisable to whole obstetric populations.

Published
2022

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