Pregnancy physiology pattern prediction study (4P study): protocol of an observational cohort study collecting vital sign information to inform the development of an accurate centile-based obstetric early warning score.

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Show simple item record Kumar, Fiona en Kemp, Jude en Edwards, Clare en Pullon, Rebecca en Loerup, Lise en Triantafyllidis, Andreas en Salvi, Dario en Gibson, Oliver en Gerry, Stephen en MacKillop, Lucy H en Tarassenko, Lionel en Watkinson, Peter J en 2018-10-11T01:37:02Z en 2017-09 en
dc.identifier.issn 2044-6055 en
dc.identifier.uri en
dc.description.abstract INTRODUCTION:Successive confidential enquiries into maternal deaths in the UK have identified an urgent need to develop a national early warning score (EWS) specifically for pregnant or recently pregnant women to aid more timely recognition, referral and treatment of women who are developing life-threatening complications in pregnancy or the puerperium. Although many local EWS are in use in obstetrics, most have been developed heuristically. No current obstetric EWS has defined the thresholds at which an alert should be triggered using evidence-based normal ranges, nor do they reflect the changing physiology that occurs with gestation during pregnancy. METHODS AND ANALYSIS:An observational cohort study involving 1000 participants across three UK sites in Oxford, London and Newcastle. Pregnant women will be recruited at approximately 14 weeks' gestation and have their vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature) measured at 4 to 6-week intervals during pregnancy. Vital signs recorded during labour and delivery will be extracted from hospital records. After delivery, participants will measure and record their own vital signs daily for 2 weeks. During the antenatal and postnatal periods, vital signs will be recorded on an Android tablet computer through a custom software application and transferred via mobile internet connection to a secure database. The data collected will be used to define reference ranges of vital signs across normal pregnancy, labour and the immediate postnatal period. This will inform the design of an evidence-based obstetric EWS. ETHICS AND DISSEMINATION:The study has been approved by the NRES committee South East Coast-Brighton and Sussex (14/LO/1312) and is registered with the ISRCTN (10838017). All participants will provide written informed consent and can withdraw from the study at any point. All data collected will be managed anonymously. The findings will be disseminated in international peer-reviewed journals and through research conferences. en
dc.format.medium Electronic en
dc.language eng en
dc.relation.ispartofseries BMJ open en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. Details obtained from en
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dc.rights.uri en
dc.subject Humans en
dc.subject Pregnancy Complications en
dc.subject Oxygen en
dc.subject Body Temperature en
dc.subject Clinical Protocols en
dc.subject Critical Care en
dc.subject Perinatal Care en
dc.subject Cohort Studies en
dc.subject Postpartum Period en
dc.subject Pregnancy en
dc.subject Blood Pressure en
dc.subject Heart Rate en
dc.subject Research Design en
dc.subject Reference Values en
dc.subject Adolescent en
dc.subject Adult en
dc.subject Middle Aged en
dc.subject Female en
dc.subject Young Adult en
dc.subject Vital Signs en
dc.subject Respiratory Rate en
dc.subject Maternal Death en
dc.subject United Kingdom en
dc.title Pregnancy physiology pattern prediction study (4P study): protocol of an observational cohort study collecting vital sign information to inform the development of an accurate centile-based obstetric early warning score. en
dc.type Journal Article en
dc.identifier.doi 10.1136/bmjopen-2017-016034 en
pubs.issue 9 en
pubs.begin-page e016034 en
pubs.volume 7 en
dc.rights.holder Copyright: The authors en
dc.identifier.pmid 28864695 en
pubs.publication-status Published en
dc.rights.accessrights en
pubs.subtype protocol en
pubs.subtype Journal Article en
pubs.subtype Observational Study en
pubs.elements-id 706494 en Medical and Health Sciences en School of Medicine en Anaesthesiology en
dc.identifier.eissn 2044-6055 en
pubs.record-created-at-source-date 2017-09-03 en
pubs.dimensions-id 28864695 en

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