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Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials

Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials
Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials
Introduction: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).

Methods and analyses: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice.

Ethics and dissemination: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women.
2044-6055
Dougall, Greig
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Franssen, Marloes
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Tucker, Katherine
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Yu, Ly-Mee
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Hinton, Lisa
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Rivero-Arias, Oliver
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Abel, Lucy
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Allen, Julie
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Band, Rebecca
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Chisholm, Alison
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Crawford, Carole
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Green, Marcus
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Greenfield, Sheila
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Hodgkinson, James
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Leeson, Paul
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McCourt, Christine
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MacKillop, Lucy
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Nickless, Alecia
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Sandall, Jane
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Santos, Mauro
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Tarassenko, Lionel
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Velardo, Carmelo
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Wilson, Hannah
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Yardley, Lucy
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Chappell, Lucy
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McManus, Richard
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Dougall, Greig
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Franssen, Marloes
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Tucker, Katherine
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Yu, Ly-Mee
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Hinton, Lisa
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Rivero-Arias, Oliver
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Abel, Lucy
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Allen, Julie
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Band, Rebecca
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Chisholm, Alison
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Crawford, Carole
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Green, Marcus
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Greenfield, Sheila
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Hodgkinson, James
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Leeson, Paul
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McCourt, Christine
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MacKillop, Lucy
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Nickless, Alecia
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Sandall, Jane
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Santos, Mauro
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Tarassenko, Lionel
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Velardo, Carmelo
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Wilson, Hannah
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Yardley, Lucy
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Chappell, Lucy
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McManus, Richard
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Dougall, Greig, Franssen, Marloes, Tucker, Katherine, Yu, Ly-Mee, Hinton, Lisa, Rivero-Arias, Oliver, Abel, Lucy, Allen, Julie, Band, Rebecca, Chisholm, Alison, Crawford, Carole, Green, Marcus, Greenfield, Sheila, Hodgkinson, James, Leeson, Paul, McCourt, Christine, MacKillop, Lucy, Nickless, Alecia, Sandall, Jane, Santos, Mauro, Tarassenko, Lionel, Velardo, Carmelo, Wilson, Hannah, Yardley, Lucy, Chappell, Lucy and McManus, Richard (2020) Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials. BMJ Open. (doi:10.1136/bmjopen-2019-034593).

Record type: Article

Abstract

Introduction: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).

Methods and analyses: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice.

Ethics and dissemination: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women.

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BUMP Protocol Paper - Version of Record
Available under License Creative Commons Attribution.
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Accepted/In Press date: 30 December 2019
e-pub ahead of print date: 23 January 2020

Identifiers

Local EPrints ID: 437868
URI: http://eprints.soton.ac.uk/id/eprint/437868
ISSN: 2044-6055
PURE UUID: f3e5480d-1467-44fb-bfe7-be49848e78f2
ORCID for Rebecca Band: ORCID iD orcid.org/0000-0001-5403-1708
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

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Date deposited: 21 Feb 2020 17:30
Last modified: 22 Feb 2020 01:33

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Contributors

Author: Greig Dougall
Author: Marloes Franssen
Author: Katherine Tucker
Author: Ly-Mee Yu
Author: Lisa Hinton
Author: Oliver Rivero-Arias
Author: Lucy Abel
Author: Julie Allen
Author: Rebecca Band ORCID iD
Author: Alison Chisholm
Author: Carole Crawford
Author: Marcus Green
Author: Sheila Greenfield
Author: James Hodgkinson
Author: Paul Leeson
Author: Christine McCourt
Author: Lucy MacKillop
Author: Alecia Nickless
Author: Jane Sandall
Author: Mauro Santos
Author: Lionel Tarassenko
Author: Carmelo Velardo
Author: Hannah Wilson
Author: Lucy Yardley ORCID iD
Author: Lucy Chappell
Author: Richard McManus

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