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Randomized Controlled Trial
. 2020 Jan 23;10(1):e034593.
doi: 10.1136/bmjopen-2019-034593.

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

Greig Dougall  1 , Marloes Franssen  1 , Katherine Louise Tucker  1 , Ly-Mee Yu  1 , Lisa Hinton  1 , Oliver Rivero-Arias  2 , Lucy Abel  1 , Julie Allen  1 , Rebecca Jane Band  3 , Alison Chisholm  1 , Carole Crawford  1 , Marcus Green  4 , Sheila Greenfield  5 , James Hodgkinson  5 , Paul Leeson  6 , Christine McCourt  7 , Lucy MacKillop  8 , Alecia Nickless  1 , Jane Sandall  9 , Mauro Santos  10 , Lionel Tarassenko  10 , Carmelo Velardo  10 , Hannah Wilson  9 , Lucy Yardley  3   11 , Lucy Chappell  12 , Richard J McManus  1
Affiliations
Randomized Controlled Trial

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

Greig Dougall et al. BMJ Open. .

Erratum in

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.

Trial registration number: NCT03334149.

Keywords: blood pressure; gestational hypertension; hypertension; pre-eclampsia; pregnancy; self-monitoring.

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Conflict of interest statement

Competing interests: RJM has previously received BP monitors from Omron for research purposes. The BP monitors for the current trials were purchased from the manufacturer (Microlife) at commercial prices.

Figures

Figure 1
Figure 1
Study design. BUMP 1, BP during higher risk pregnancy; CH, chronic hypertension; GH, gestational hypertension; HT, hypertension; NT, normotension.
Figure 2
Figure 2
BP interpretation chart for BUMP 1. BUMP1, BP during higher risk pregnancy.
Figure 3
Figure 3
BP interpretation chart for BUMP 2. BUMP 2, BP during hypertensive pregnancy.
Figure 4
Figure 4
BUMP 1 study visit chart. BP, blood pressure; BUMP 1, BP during higher risk pregnancy.
Figure 5
Figure 5
BUMP 2 study visit chart. BP, blood pressure; BUMP 2, BP during hypertensive pregnancy.
See this image and copyright information in PMC

References

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