Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension during Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial

Katherine L. Tucker; Sam Mort; Ly Mee Yu; Helen Campbell; Oliver Rivero-Arias; Hannah M. Wilson; Julie Allen; Rebecca Band; Alison Chisholm; Carole Crawford; Greig Dougall; Lazarina Engonidou; Marloes Franssen; Marcus Green; Sheila Greenfield; Lisa Hinton; James Hodgkinson; Layla Lavallee; Paul Leeson; Christine McCourt; Lucy Mackillop; Jane Sandall; Mauro Santos; Lionel Tarassenko; Carmelo Velardo; Lucy Yardley; Lucy C. Chappell; Richard J. McManus

doi:10.1001/jama.2022.4712

Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension during Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial

Katherine L. Tucker, Sam Mort, Ly Mee Yu, Helen Campbell, Oliver Rivero-Arias, Hannah M. Wilson, Julie Allen, Rebecca Band, Alison Chisholm, Carole Crawford, Greig Dougall, Lazarina Engonidou, Marloes Franssen, Marcus Green, Sheila Greenfield, Lisa Hinton, James Hodgkinson, Layla Lavallee, Paul Leeson, Christine McCourtLucy Mackillop, Jane Sandall, Mauro Santos, Lionel Tarassenko, Carmelo Velardo, Lucy Yardley, Lucy C. Chappell, Richard J. McManus

Women & Children's Health

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

51 Citations (Scopus)

Abstract

Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P =.64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

Original language	English
Pages (from-to)	1656-1665
Number of pages	10
Journal	JAMA - Journal of the American Medical Association
Volume	327
Issue number	17
DOIs	https://doi.org/10.1001/jama.2022.4712
Publication status	Published - 3 May 2022

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Tucker, K. L., Mort, S., Yu, L. M., Campbell, H., Rivero-Arias, O., Wilson, H. M., Allen, J., Band, R., Chisholm, A., Crawford, C., Dougall, G., Engonidou, L., Franssen, M., Green, M., Greenfield, S., Hinton, L., Hodgkinson, J., Lavallee, L., Leeson, P., ... McManus, R. J. (2022). Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension during Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial. JAMA - Journal of the American Medical Association, 327(17), 1656-1665. https://doi.org/10.1001/jama.2022.4712

@article{f1cbe366b670485d8d9bd322b2397a81,

title = "Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension during Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial",

abstract = "Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P =.64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.",

author = "Tucker, {Katherine L.} and Sam Mort and Yu, {Ly Mee} and Helen Campbell and Oliver Rivero-Arias and Wilson, {Hannah M.} and Julie Allen and Rebecca Band and Alison Chisholm and Carole Crawford and Greig Dougall and Lazarina Engonidou and Marloes Franssen and Marcus Green and Sheila Greenfield and Lisa Hinton and James Hodgkinson and Layla Lavallee and Paul Leeson and Christine McCourt and Lucy Mackillop and Jane Sandall and Mauro Santos and Lionel Tarassenko and Carmelo Velardo and Lucy Yardley and Chappell, {Lucy C.} and McManus, {Richard J.}",

note = "Funding Information: Conflict of Interest Disclosures: Dr Rivero-Arias reported being a member of the EuroQol Group, which is the copyright holder of the EQ-5D instruments. Ms Engonidou reported the BUMP intervention was licensed by Oxford University for free during the pandemic and the University has received fees subsequently from Sensyne during the conduct of the study; and receiving licenses and paid consultancy to the University of Oxford with regard to a telemonitoring intervention for Omron. Dr Mackillop reported receiving personal fees from Sensyne Health plc outside the submitted work. Dr Santos reported receiving personal fees from Sensyne Health Group outside the submitted work; and holding a patent for Oxford University Innovation Project 17725, BUMP - Technology License licensed to Sensyne Health Group. Dr Tarassenko reported personal fees from Sensyne Health and grants from Sensyne Health outside the submitted work. Dr Velardo reported holding a patent for Oxford University Innovation Project 17725, BUMP - Technology License licensed to Sensyne Health Group. Dr McManus reported fees from Sensyne; the BUMP intervention was licensed by Oxford University for free during the pandemic and the university has received fees subsequently during the conduct of the study; and licenses and paid consultancy to the University of Oxford from Omron with regard to a telemonitoring intervention. Dr McManus also reported occasional travel reimbursement and accommodation for speaking at conferences, most recently ESH and ASN in 2019. Any honoraria were paid to his institution. No other disclosures were reported. Publisher Copyright: {\textcopyright} 2022 American Medical Association. All rights reserved.",

year = "2022",

month = may,

day = "3",

doi = "10.1001/jama.2022.4712",

language = "English",

volume = "327",

pages = "1656--1665",

journal = "JAMA - Journal of the American Medical Association",

issn = "0098-7484",

publisher = "American Medical Association (AMA)",

number = "17",

}

Tucker, KL, Mort, S, Yu, LM, Campbell, H, Rivero-Arias, O, Wilson, HM, Allen, J, Band, R, Chisholm, A, Crawford, C, Dougall, G, Engonidou, L, Franssen, M, Green, M, Greenfield, S, Hinton, L, Hodgkinson, J, Lavallee, L, Leeson, P, McCourt, C, Mackillop, L, Sandall, J, Santos, M, Tarassenko, L, Velardo, C, Yardley, L, Chappell, LC & McManus, RJ 2022, 'Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension during Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial', JAMA - Journal of the American Medical Association, vol. 327, no. 17, pp. 1656-1665. https://doi.org/10.1001/jama.2022.4712

TY - JOUR

T1 - Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension during Higher-Risk Pregnancy

T2 - The BUMP 1 Randomized Clinical Trial

AU - Tucker, Katherine L.

AU - Mort, Sam

AU - Yu, Ly Mee

AU - Campbell, Helen

AU - Rivero-Arias, Oliver

AU - Wilson, Hannah M.

AU - Allen, Julie

AU - Band, Rebecca

AU - Chisholm, Alison

AU - Crawford, Carole

AU - Dougall, Greig

AU - Engonidou, Lazarina

AU - Franssen, Marloes

AU - Green, Marcus

AU - Greenfield, Sheila

AU - Hinton, Lisa

AU - Hodgkinson, James

AU - Lavallee, Layla

AU - Leeson, Paul

AU - McCourt, Christine

AU - Mackillop, Lucy

AU - Sandall, Jane

AU - Santos, Mauro

AU - Tarassenko, Lionel

AU - Velardo, Carmelo

AU - Yardley, Lucy

AU - Chappell, Lucy C.

AU - McManus, Richard J.

N1 - Funding Information: Conflict of Interest Disclosures: Dr Rivero-Arias reported being a member of the EuroQol Group, which is the copyright holder of the EQ-5D instruments. Ms Engonidou reported the BUMP intervention was licensed by Oxford University for free during the pandemic and the University has received fees subsequently from Sensyne during the conduct of the study; and receiving licenses and paid consultancy to the University of Oxford with regard to a telemonitoring intervention for Omron. Dr Mackillop reported receiving personal fees from Sensyne Health plc outside the submitted work. Dr Santos reported receiving personal fees from Sensyne Health Group outside the submitted work; and holding a patent for Oxford University Innovation Project 17725, BUMP - Technology License licensed to Sensyne Health Group. Dr Tarassenko reported personal fees from Sensyne Health and grants from Sensyne Health outside the submitted work. Dr Velardo reported holding a patent for Oxford University Innovation Project 17725, BUMP - Technology License licensed to Sensyne Health Group. Dr McManus reported fees from Sensyne; the BUMP intervention was licensed by Oxford University for free during the pandemic and the university has received fees subsequently during the conduct of the study; and licenses and paid consultancy to the University of Oxford from Omron with regard to a telemonitoring intervention. Dr McManus also reported occasional travel reimbursement and accommodation for speaking at conferences, most recently ESH and ASN in 2019. Any honoraria were paid to his institution. No other disclosures were reported. Publisher Copyright: © 2022 American Medical Association. All rights reserved.

PY - 2022/5/3

Y1 - 2022/5/3

N2 - Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P =.64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

AB - Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P =.64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.

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DO - 10.1001/jama.2022.4712

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JF - JAMA - Journal of the American Medical Association

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ER -

Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension during Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial

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