Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol

Sarah Jane Stock; Amarnath Bhide; Heather Richardson; Mairead Black; Cassandra Yuill; Mairi Harkness; Maggie Reid; Fiona Wee; Helen Cheyne; Christine McCourt; Dikshyanta Rana; Kathleen Anne Boyd; Julia Sanders; Neelam Heera; Jane Huddleston; Fiona Denison; Dharmintra Pasupathy; Neena Modi; Gordon Smith; John Norrie

doi:10.1136/bmjopen-2021-050452

Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol

Sarah Jane Stock^* (Corresponding Author), Amarnath Bhide, Heather Richardson, Mairead Black, Cassandra Yuill, Mairi Harkness, Maggie Reid, Fiona Wee, Helen Cheyne, Christine McCourt, Dikshyanta Rana, Kathleen Anne Boyd, Julia Sanders, Neelam Heera, Jane Huddleston, Fiona Denison, Dharmintra Pasupathy, Neena Modi, Gordon Smith, John Norrie

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

INTRODUCTION: 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.

Original language	English
Article number	e050452
Number of pages	10
Journal	BMJ Open
Volume	11
Issue number	5
Early online date	4 May 2021
DOIs	https://doi.org/10.1136/bmjopen-2021-050452
Publication status	Published - 4 May 2021

Bibliographical note

Funding CHOICE is funded by the National Institute of Healthcare Research (NIHR) Health Technology and Assessment (NIHR 127569). SJS is supported by Wellcome Trust (209560/Z/17/Z).

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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Stock, S. J., Bhide, A., Richardson, H., Black, M., Yuill, C., Harkness, M., Reid, M., Wee, F., Cheyne, H., McCourt, C., Rana, D., Boyd, K. A., Sanders, J., Heera, N., Huddleston, J., Denison, F., Pasupathy, D., Modi, N., Smith, G., & Norrie, J. (2021). Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol. BMJ Open, 11(5), Article e050452. https://doi.org/10.1136/bmjopen-2021-050452

Stock, 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, Denison, F, Pasupathy, D, Modi, N, Smith, G & Norrie, J 2021, 'Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol', BMJ Open, vol. 11, no. 5, e050452. https://doi.org/10.1136/bmjopen-2021-050452

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title = "Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol",

abstract = "INTRODUCTION: 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.",

author = "Stock, {Sarah Jane} and Amarnath Bhide and Heather Richardson and Mairead Black and Cassandra Yuill and Mairi Harkness and Maggie Reid and Fiona Wee and Helen Cheyne and Christine McCourt and Dikshyanta Rana and Boyd, {Kathleen Anne} and Julia Sanders and Neelam Heera and Jane Huddleston and Fiona Denison and Dharmintra Pasupathy and Neena Modi and Gordon Smith and John Norrie",

note = "Funding CHOICE is funded by the National Institute of Healthcare Research (NIHR) Health Technology and Assessment (NIHR 127569). SJS is supported by Wellcome Trust (209560/Z/17/Z).",

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T1 - Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study

T2 - a protocol

AU - Stock, Sarah Jane

AU - Bhide, Amarnath

AU - Richardson, Heather

AU - Black, Mairead

AU - Yuill, Cassandra

AU - Harkness, Mairi

AU - Reid, Maggie

AU - Wee, Fiona

AU - Cheyne, Helen

AU - McCourt, Christine

AU - Rana, Dikshyanta

AU - Boyd, Kathleen Anne

AU - Sanders, Julia

AU - Heera, Neelam

AU - Huddleston, Jane

AU - Denison, Fiona

AU - Pasupathy, Dharmintra

AU - Modi, Neena

AU - Smith, Gordon

AU - Norrie, John

N1 - Funding CHOICE is funded by the National Institute of Healthcare Research (NIHR) Health Technology and Assessment (NIHR 127569). SJS is supported by Wellcome Trust (209560/Z/17/Z).

PY - 2021/5/4

Y1 - 2021/5/4

N2 - INTRODUCTION: 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.

AB - INTRODUCTION: 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.

U2 - 10.1136/bmjopen-2021-050452

DO - 10.1136/bmjopen-2021-050452

M3 - Article

C2 - 33947741

SN - 2044-6055

VL - 11

JO - BMJ Open

JF - BMJ Open

IS - 5

M1 - e050452

ER -

Cervical ripening at home or in-hospital—prospective cohort study and process evaluation (CHOICE) study: a protocol

Abstract

Bibliographical note

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