Key result
The BUMP 1 and 2 trials are designed to evaluate whether blood pressure self-monitoring with telemonitoring improves detection of raised BP and reduces systolic BP during high-risk pregnancies.
Why the study?
Self-monitoring of blood pressure in pregnancy could improve the detection and management of pregnancy hypertension while empowering women in their care, but its effects on detecting raised blood pressure and reducing systolic blood pressure required evaluation.
Does self-monitoring of blood pressure with telemonitoring improve the detection of raised blood pressure and reduce systolic blood pressure in high-risk or hypertensive pregnancies?
RCT (n=2,774)
Open-label
parallel group
Yes
Does self-monitoring of blood pressure with telemonitoring improve the detection of raised blood pressure and reduce systolic blood pressure in high-risk or hypertensive pregnancies?
This protocol outlines two linked trials to determine if blood pressure self-monitoring improves the detection and management of hypertension during pregnancy.
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.
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Dougall et al. (2020) conducted an RCT in Pregnancy hypertension (n=2,774). Self-monitoring of blood pressure with telemonitoring vs. Usual care was evaluated on Time to the first recording of raised BP by a healthcare professional (BUMP 1); mean systolic BP between baseline and delivery recorded by healthcare professionals (BUMP 2). The BUMP 1 and 2 trials are designed to evaluate whether blood pressure self-monitoring with telemonitoring improves detection of raised BP and reduces systolic BP during high-risk pregnancies.
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