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dc.contributor.authorStock, Sarah Janeen_UK
dc.contributor.authorBhide, Amarnathen_UK
dc.contributor.authorRichardson, Heatheren_UK
dc.contributor.authorBlack, Maireaden_UK
dc.contributor.authorYuill, Cassandraen_UK
dc.contributor.authorHarkness, Mairien_UK
dc.contributor.authorReid, Maggieen_UK
dc.contributor.authorWee, Fionaen_UK
dc.contributor.authorCheyne, Helenen_UK
dc.contributor.authorMcCourt, Christineen_UK
dc.contributor.authorRana, Dikshyantaen_UK
dc.contributor.authorBoyd, Kathleen Anneen_UK
dc.contributor.authorSanders, Juliaen_UK
dc.contributor.authorHeera, Neelamen_UK
dc.contributor.authorHuddleston, Janeen_UK
dc.description.abstractIntroduction The aim of the cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study is to compare home versus in-hospital cervical ripening to determine whether home cervical ripening is safe (for the primary outcome of neonatal unit (NNU) admission), acceptable to women and cost-effective from the perspective of both women and the National Health Service (NHS). Methods and analysis We will perform a prospective multicentre observational cohort study with an internal pilot phase. We will obtain data from electronic health records from at least 14 maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also conduct a cost-effectiveness analysis and a mixed methods study to evaluate processes and women/partner experiences. Our primary sample size is 8533 women with singleton pregnancies undergoing induction of labour (IOL) at 39+0 weeks’ gestation or more. To achieve this and contextualise our findings, we will collect data relating to a cohort of approximately 41 000 women undergoing IOL after 37 weeks. We will use mixed effects logistic regression for the non-inferiority comparison of NNU admission and propensity score matched adjustment to control for treatment indication bias. The economic analysis will be undertaken from the perspective of the NHS and Personal Social Services (PSS) and the pregnant woman. It will include a within-study cost-effectiveness analysis and a lifetime cost–utility analysis to account for any long-term impacts of the cervical ripening strategies. Outcomes will be reported as incremental cost per NNU admission avoided and incremental cost per quality adjusted life year gained. Research ethics approval and dissemination CHOICE has been funded and approved by the National Institute of Healthcare Research Health Technology and Assessment, and the results will be disseminated via publication in peer-reviewed journals. Trial registration number ISRCTN32652461.en_UK
dc.publisherBMJ Publishing Groupen_UK
dc.relationStock SJ, Bhide A, Richardson H, Black M, Yuill C, Harkness M, Reid M, Wee F, Cheyne H, McCourt C, Rana D, Boyd KA, Sanders J, Heera N & Huddleston J (2021) Cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study: a protocol. BMJ Open, 11 (5), Art. No.: e050452.
dc.rights© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:
dc.titleCervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study: a protocolen_UK
dc.typeJournal Articleen_UK
dc.citation.jtitleBMJ Openen_UK
dc.type.statusVoR - Version of Recorden_UK
dc.contributor.funderNIHR National Institute for Health Researchen_UK
dc.description.notesAdditional co-authors: Fiona Denison, Dharmintra Pasupathy, Neena Modi, Gordon Smith, John Norrieen_UK
dc.contributor.affiliationUniversity of Edinburghen_UK
dc.contributor.affiliationSt George's University Hospitals NHSen_UK
dc.contributor.affiliationNHS Lothian University Hospitals Divisionen_UK
dc.contributor.affiliationUniversity of Aberdeenen_UK
dc.contributor.affiliationCity University Londonen_UK
dc.contributor.affiliationUniversity of Edinburghen_UK
dc.contributor.affiliationUniversity of Edinburghen_UK
dc.contributor.affiliationCity University Londonen_UK
dc.contributor.affiliationUniversity of Glasgowen_UK
dc.contributor.affiliationUniversity of Glasgowen_UK
dc.contributor.affiliationCardiff Universityen_UK
dc.relation.funderprojectOutpatient cervical ripening for induction of labouren_UK
dc.relation.funderrefNIHR HTA: NIHR127569en_UK
rioxxterms.apcnot requireden_UK
rioxxterms.typeJournal Article/Reviewen_UK
local.rioxx.authorStock, Sarah Jane|en_UK
local.rioxx.authorBhide, Amarnath|en_UK
local.rioxx.authorRichardson, Heather|en_UK
local.rioxx.authorBlack, Mairead|en_UK
local.rioxx.authorYuill, Cassandra|en_UK
local.rioxx.authorHarkness, Mairi|0000-0002-1007-7648en_UK
local.rioxx.authorReid, Maggie|en_UK
local.rioxx.authorWee, Fiona|en_UK
local.rioxx.authorCheyne, Helen|0000-0001-5738-8390en_UK
local.rioxx.authorMcCourt, Christine|en_UK
local.rioxx.authorRana, Dikshyanta|en_UK
local.rioxx.authorBoyd, Kathleen Anne|en_UK
local.rioxx.authorSanders, Julia|en_UK
local.rioxx.authorHeera, Neelam|en_UK
local.rioxx.authorHuddleston, Jane|en_UK
local.rioxx.projectNIHR HTA: NIHR127569|National Institute for Health Research|
Appears in Collections:Faculty of Health Sciences and Sport Journal Articles

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