Remote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).
Blood pressure
Gestational hypertension
High-risk pregnancy
Home blood pressure monitoring
Hypertensive disorders of pregnancy
Mobile health
Preeclampsia
Randomised controlled trial
Remote monitoring
Self-monitoring
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
17 May 2023
17 May 2023
Historique:
received:
06
08
2022
accepted:
20
04
2023
medline:
19
5
2023
pubmed:
18
5
2023
entrez:
17
5
2023
Statut:
epublish
Résumé
Pregnant women at high risk for developing a hypertensive disorder of pregnancy require frequent antenatal assessments, especially of their blood pressure. This expends significant resources for both the patient and healthcare system. An alternative to in-clinic assessments is a remote blood pressure monitoring strategy, in which patients self-record their blood pressure at home using a validated blood pressure machine. This has the potential to be cost-effective, increase patient satisfaction, and reduce outpatient visits, and has had widespread uptake recently given the increased need for remote care during the ongoing COVID-19 pandemic. However robust evidence supporting this approach over a traditional face-to-face approach is lacking, and the impact on maternal and foetal outcomes has not yet been reported. Thus, there is an urgent need to assess the efficacy of remote monitoring in pregnant women at high risk of developing a hypertensive disorder of pregnancy. The REMOTE CONTROL trial is a pragmatic, unblinded, randomised controlled trial, which aims to compare remote blood pressure monitoring in high-risk pregnant women with conventional face-to-face clinic monitoring, in a 1:1 allocation ratio. The study will recruit patients across 3 metropolitan Australian teaching hospitals and will evaluate the safety, cost-effectiveness, impact on healthcare utilisation and end-user satisfaction of remote blood pressure monitoring. Remote blood pressure monitoring is garnering interest worldwide and has been increasingly implemented following the COVID-19 pandemic. However, robust data regarding its safety for maternofoetal outcomes is lacking. The REMOTE CONTROL trial is amongst the first randomised controlled trials currently underway, powered to evaluate maternal and foetal outcomes. If proven to be as safe as conventional clinic monitoring, major potential benefits include reducing clinic visits, waiting times, travel costs, and improving delivery of care to vulnerable populations in rural and remote communities. The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).
Sections du résumé
BACKGROUND
BACKGROUND
Pregnant women at high risk for developing a hypertensive disorder of pregnancy require frequent antenatal assessments, especially of their blood pressure. This expends significant resources for both the patient and healthcare system. An alternative to in-clinic assessments is a remote blood pressure monitoring strategy, in which patients self-record their blood pressure at home using a validated blood pressure machine. This has the potential to be cost-effective, increase patient satisfaction, and reduce outpatient visits, and has had widespread uptake recently given the increased need for remote care during the ongoing COVID-19 pandemic. However robust evidence supporting this approach over a traditional face-to-face approach is lacking, and the impact on maternal and foetal outcomes has not yet been reported. Thus, there is an urgent need to assess the efficacy of remote monitoring in pregnant women at high risk of developing a hypertensive disorder of pregnancy.
METHODS
METHODS
The REMOTE CONTROL trial is a pragmatic, unblinded, randomised controlled trial, which aims to compare remote blood pressure monitoring in high-risk pregnant women with conventional face-to-face clinic monitoring, in a 1:1 allocation ratio. The study will recruit patients across 3 metropolitan Australian teaching hospitals and will evaluate the safety, cost-effectiveness, impact on healthcare utilisation and end-user satisfaction of remote blood pressure monitoring.
DISCUSSION
CONCLUSIONS
Remote blood pressure monitoring is garnering interest worldwide and has been increasingly implemented following the COVID-19 pandemic. However, robust data regarding its safety for maternofoetal outcomes is lacking. The REMOTE CONTROL trial is amongst the first randomised controlled trials currently underway, powered to evaluate maternal and foetal outcomes. If proven to be as safe as conventional clinic monitoring, major potential benefits include reducing clinic visits, waiting times, travel costs, and improving delivery of care to vulnerable populations in rural and remote communities.
TRIAL REGISTRATION
BACKGROUND
The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).
Identifiants
pubmed: 37198630
doi: 10.1186/s13063-023-07321-0
pii: 10.1186/s13063-023-07321-0
pmc: PMC10189218
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
334Informations de copyright
© 2023. The Author(s).
Références
Eur J Obstet Gynecol Reprod Biol. 2018 Apr;223:72-78
pubmed: 29500948
Ultrasound Obstet Gynecol. 2020 Jul;56(1):7-10
pubmed: 32506723
Obstet Gynecol. 2019 Oct;134(4):685-691
pubmed: 31503166
Pregnancy Hypertens. 2016 Oct;6(4):263-265
pubmed: 27939464
Pregnancy Hypertens. 2019 Oct;18:141-149
pubmed: 31618706
BJOG. 2020 Nov;127(12):1516-1526
pubmed: 32416644
BMJ Qual Saf. 2018 Nov;27(11):871-877
pubmed: 29703800
Circulation. 2011 Jun 21;123(24):2856-69
pubmed: 21690502
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Pregnancy Hypertens. 2019 Jan;15:171-176
pubmed: 30825917
JMIR Res Protoc. 2016 Nov 18;5(4):e200
pubmed: 27864167
Hypertens Pregnancy. 2008;27(3):305-13
pubmed: 18696359
Am J Obstet Gynecol. 2020 Oct;223(4):585-588
pubmed: 32439388
Integr Blood Press Control. 2015 Mar 03;8:7-12
pubmed: 25767405
BMJ. 2011 Jun 24;342:d3621
pubmed: 21705406
Pregnancy Hypertens. 2019 Oct;18:14-20
pubmed: 31442829
Int J Biomed Comput. 1987 Nov;21(3-4):175-87
pubmed: 3679578
Korean Circ J. 2010 Sep;40(9):423-31
pubmed: 20967142
Dis Manag. 2006 Aug;9(4):236-41
pubmed: 16893336
BMJ Open. 2013 Jul 24;3(7):
pubmed: 23883883
Semin Perinatol. 2012 Feb;36(1):56-9
pubmed: 22280867
Ultrasound Obstet Gynecol. 2019 Apr;53(4):496-502
pubmed: 29516615
Ann Med. 2001 Jul;33(5):337-43
pubmed: 11491192
Pregnancy Hypertens. 2020 Jan;19:44-51
pubmed: 31901652
Ultrasound Obstet Gynecol. 2018 Apr;51(4):524-530
pubmed: 29468771
Diabetes Technol Ther. 2021 May;23(5):358-366
pubmed: 33210954
Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:226-231
pubmed: 31330428
Br J Psychiatry. 1987 Jun;150:782-6
pubmed: 3651732
JAMA. 2012 Dec 26;308(24):2594-604
pubmed: 23268518
Hypertension. 2018 Aug;72(2):425-432
pubmed: 29967037
BJOG. 2000 Feb;107(2):217-21
pubmed: 10688505
BMJ Open Qual. 2020 Nov;9(4):
pubmed: 33148603
Pregnancy Hypertens. 2020 Oct;22:30-36
pubmed: 32717653
Ultrasound Obstet Gynecol. 2017 Oct;50(4):492-495
pubmed: 28741785
Pregnancy Hypertens. 2020 Oct;22:156-159
pubmed: 32980623
J Nurs Meas. 2009;17(1):19-28
pubmed: 19902657
Am J Obstet Gynecol. 2022 Feb;226(2S):S1222-S1236
pubmed: 32828743
Hypertension. 2020 Apr;75(4):1125-1132
pubmed: 32114852
BMJ. 2019 Apr 29;365:l1516
pubmed: 31036557
BMC Pregnancy Childbirth. 2017 Dec 28;17(1):442
pubmed: 29284456