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
{"title":"自我监测血压对高危妊娠期高血压诊断的影响:BUMP 1 随机临床试验。","authors":"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","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was time to first recorded hypertension measured by a health care professional.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03334149.</p>","PeriodicalId":46187,"journal":{"name":"International Journal of Security and Its Applications","volume":"10 1","pages":"1656-1665"},"PeriodicalIF":0.0000,"publicationDate":"2022-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9066279/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.\",\"authors\":\"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\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension.</p><p><strong>Design, setting, and participants: </strong>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.</p><p><strong>Interventions: </strong>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.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was time to first recorded hypertension measured by a health care professional.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03334149.</p>\",\"PeriodicalId\":46187,\"journal\":{\"name\":\"International Journal of Security and Its Applications\",\"volume\":\"10 1\",\"pages\":\"1656-1665\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-05-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9066279/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Security and Its Applications\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jama.2022.4712\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Security and Its Applications","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jama.2022.4712","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.
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.
期刊介绍:
IJSIA aims to facilitate and support research related to security technology and its applications. Our Journal provides a chance for academic and industry professionals to discuss recent progress in the area of security technology and its applications. Journal Topics: -Access Control -Ad Hoc & Sensor Network Security -Applied Cryptography -Authentication and Non-repudiation -Cryptographic Protocols -Denial of Service -E-Commerce Security -Identity and Trust Management -Information Hiding -Insider Threats and Countermeasures -Intrusion Detection & Prevention -Network & Wireless Security -Peer-to-Peer Security -Privacy and Anonymity -Secure installation, generation and operation -Security Analysis Methodologies -Security assurance -Security in Software Outsourcing -Security products or systems -Security technology -Systems and Data Security