Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001049965
Ethics application status
Approved
Date submitted
1/07/2020
Date registered
15/10/2020
Date last updated
21/01/2024
Date data sharing statement initially provided
15/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote blood pressure monitoring in high risk pregnancy – a randomised controlled trial (REMOTE CONTROL trial)
Scientific title
Remote blood pressure monitoring in high risk pregnancy - A randomised controlled trial (REMOTE CONTROL trial) evaluating maternal and fetal outcomes
Secondary ID [1] 301667 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertensive disorders of pregnancy 318108 0
Chronic hypertension 318109 0
Preeclampsia 318110 0
Gestational hypertension 318111 0
Superimposed preeclampsia 318112 0
Condition category
Condition code
Cardiovascular 316131 316131 0 0
Hypertension
Reproductive Health and Childbirth 316132 316132 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional arm: Home-based blood pressure monitoring using an automated blood pressure monitor validated in pregnancy and preeclampsia (brand yet to be confirmed), in conjunction with an app-based system which will allow collection of blood pressure readings remotely. The app will be developed by the investigators of this study. Blood pressure will be recorded 3 times a week by participants. The readings will be transmitted automatically to the application which will transmit these readings to the clinicians dashboard.
Participants in this arm will undergo education and training from the research nurse on the use of the automated BP machine and app-based system on the initial visit. This will be a one-on-one face-to-face education session, lasting 20 minutes. Instead of face-to-face consultations, care will subsequently occur remotely using Telehealth medicine by Obstetric physicians for review of symptoms and home-based blood pressure readings, to monitor and manage hypertensive disorders in pregnancy. The frequency of review will be dictated by the Obstetric physician based on clinical need, with at least 2 visits over the entire antepartum period, from enrolment in to the study to delivery. At least one further appointment in the postpartum period will occur from delivery to 6 weeks postpartum.
Adherence will be assessed by the app-based system which will provide alerts if adherence with regular blood pressure monitoring is poor. These alerts will also be provided to the clinical team, who will review participant recordings on a weekly basis.
Intervention code [1] 317978 0
Diagnosis / Prognosis
Comparator / control treatment
Control arm: Usual care, which is hypertensive pregnant women having regular review in the Obstetric Medicine clinic. This will be undertaken with face-to-face consultations and an outpatient clinic blood pressure measurement. Frequency of visits will be dictated by the Obstetric physician based on clinical need, as is the current standard of care.
Control group
Active

Outcomes
Primary outcome [1] 324321 0
Rate of composite fetal outcome:
- perinatal loss defined as miscarriage, pregnancy termination, stillbirth or neonatal death - assessed using hospital medical records and eHealth linkage to NSW hospitals.
Timepoint [1] 324321 0
- perinatal loss assessed from enrolment till loss of child or birth of child
Primary outcome [2] 325415 0
- high-level neonatal care for >48 hours defined as admission to neonatal ICU or special care nursery, for > 48 hours - assessed using hospital medical records and eHealth linkage to NSW hospitals.
Timepoint [2] 325415 0
- high-level neonatal care for >48 hours defined as admission to neonatal ICU or special care nursery, for > 48 hours - assessed from delivery to 6 weeks postpartum
Primary outcome [3] 325416 0
- small for gestational age defined as birthweight below the 10th centile. - assessed using birthweight corrected for gestational age recorded on the labour record.
Timepoint [3] 325416 0
- small for gestational age defined as birthweight below the 10th centile. - assessed at delivery, birthweight corrected for gestational age.
Secondary outcome [1] 384314 0
Rate of composite maternal complications:
- Abruption - assessed using hospital medical records
Timepoint [1] 384314 0
Rate of composite maternal complications:
- Abruption - enrolment to delivery
Secondary outcome [2] 387862 0
- HELLP syndrome - assessed using pathology from hospital records
Timepoint [2] 387862 0
- HELLP syndrome - enrolment to delivery
Secondary outcome [3] 387863 0
- eclampsia - assessed using hospital medical records
Timepoint [3] 387863 0
- eclampsia - enrolment to 6 weeks postpartum
Secondary outcome [4] 387864 0
- transient ischaemic attack or stroke - assessed using assessed using hospital medical records and MRI brain
Timepoint [4] 387864 0
- transient ischaemic attack or stroke - enrolment to 6 weeks postpartum
Secondary outcome [5] 387865 0
- pulmonary oedema - assessed using hospital medical records and radiology
Timepoint [5] 387865 0
- pulmonary oedema - enrolment to 6 weeks postpartum
Secondary outcome [6] 387866 0
- renal failure, liver involvement, haematological involvement - assessed using pathology from hospital records
Timepoint [6] 387866 0
- renal failure, liver involvement, haematological involvement - enrolment to delivery
Secondary outcome [7] 387867 0
- Death - assessed using pathology from hospital records
Timepoint [7] 387867 0
- Death - enrolment to 6 weeks postpartum
Secondary outcome [8] 387868 0
- Cost-effectiveness - assessed using pricing for consumables and MBS codes for consultations, in addition to qualitative interviews
Timepoint [8] 387868 0
- Cost-effectiveness - enrolment to 6 weeks postpartum
Secondary outcome [9] 387869 0
- compliance - assessed using the application
Timepoint [9] 387869 0
- compliance - enrolment to 6 weeks postpartum
Secondary outcome [10] 387870 0
- patient satisfaction - assessed using qualitative interviews and validated questionnaires
Timepoint [10] 387870 0
- patient satisfaction - at enrolment, 34 weeks gestation and 6 weeks postpartum

Eligibility
Key inclusion criteria
Able to provide informed consent
Able and willing to follow instructions for use of automated BP machine and app-based system
Chronic hypertension (systolic BP >140 or diastolic BP >90) before 20 weeks’ gestation
Gestational hypertension(systolic BP >140 or diastolic BP >90) after 20 weeks’ gestation
Confirmation of viable intrauterine pregnancy on dating scan
Enrolment before 37 weeks gestation
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Signs of severe preeclampsia on initial evaluation
Inability to utilise smart phone device or app-based system
Plan to terminate pregnancy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22160 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 22161 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 22162 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 37312 0
2560 - Campbelltown
Recruitment postcode(s) [2] 37313 0
2170 - Liverpool
Recruitment postcode(s) [3] 37314 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 306101 0
Other Collaborative groups
Name [1] 306101 0
Vascular Immunology group
Country [1] 306101 0
Australia
Primary sponsor type
Individual
Name
Theepika Rajkumar
Address
Macathur Clinical School, Western Sydney University
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560
Country
Australia
Secondary sponsor category [1] 306571 0
Individual
Name [1] 306571 0
Angela Makris
Address [1] 306571 0
Department of Nephrology, Liverpool Hospital, Corner of Elizabeth and Goulburn Streets LIVERPOOL NSW 2170
Country [1] 306571 0
Australia
Secondary sponsor category [2] 307047 0
Individual
Name [2] 307047 0
Annemarie Hennessy
Address [2] 307047 0
Department of Medicine
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560
Country [2] 307047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306320 0
South Western Sydney Local Health District Ethics
Ethics committee address [1] 306320 0
Liverpool Hospital, Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Ethics committee country [1] 306320 0
Australia
Date submitted for ethics approval [1] 306320 0
01/12/2020
Approval date [1] 306320 0
15/04/2021
Ethics approval number [1] 306320 0
2021/ETH000528

Summary
Brief summary
Hypertension is one of the most common complications of pregnancy, affecting 2-10% of pregnant women. It is associated with adverse maternal and fetal outcomes, such as eclampsia, stroke, fetal growth restriction and stillbirth. Maternal mortality approaches 15% globally. Monitoring, early recognition and treatment are key to reducing severe complications and mortality. Traditionally in pregnancy, blood pressure (BP) is monitored routinely at outpatient visits. However, major recent events - the Australian bushfires and the COVID-19 pandemic, limited social movement, and therefore initiated major change to antenatal healthcare delivery. There was widespread uptake of Telehealth services and home monitoring of BP. Patients are recording their own BP, directed by a healthcare professional on the frequency of monitoring, and given criteria as to when to attend the hospital. In non-pregnant populations, ambulatory and home BP measurements have been shown to have a closer association with long-term health effects, compared to clinic BP measurements. This is reflected in international guidelines, such as the American Heart Association, and the European Society of Hypertension guidelines, which emphasises the importance of BP self-monitoring. However, this practice is not validated in the pregnant population, and the effect on maternal and fetal outcomes has not been quantified.
Our study is a multi-centre, cluster randomised controlled trial investigating antenatal home-based blood pressure monitoring when compared with usual care, through exploring maternal and perinatal outcomes, cost-effectiveness, compliance and qualitative patient satisfaction data.
Home BP monitoring could provide more accurate data for clinicians to use in management strategies, thereby reducing poor fetal and maternal outcomes, and the burden of multiple clinic visits. Additionally, home-based monitoring would be useful in future events that would require our population to limit social movement, such as in bushfires and health pandemics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103494 0
Dr Theepika Rajkumar
Address 103494 0
Macathur Clinical School, Western Sydney University
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560
Country 103494 0
Australia
Phone 103494 0
+61 246343000
Fax 103494 0
Email 103494 0
[email protected]
Contact person for public queries
Name 103495 0
Dr Theepika Rajkumar
Address 103495 0
Macathur Clinical School, Western Sydney University
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560
Country 103495 0
Australia
Phone 103495 0
+61 246343000
Fax 103495 0
Email 103495 0
[email protected]
Contact person for scientific queries
Name 103496 0
Dr Theepika Rajkumar
Address 103496 0
Macathur Clinical School, Western Sydney University
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560
Country 103496 0
Australia
Phone 103496 0
+61 246343000
Fax 103496 0
Email 103496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified data will be shared
When will data be available (start and end dates)?
From data collection till 7 years after
Available to whom?
Upon request to other investigators undertaking meta-analyses
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Through contacting the primary investigator via [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8375Study protocol    Study protocol will be available once ethics appro... [More Details]
8376Informed consent form    Informed consent form will be available once ethic... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseR emote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).2023https://dx.doi.org/10.1186/s13063-023-07321-0
N.B. These documents automatically identified may not have been verified by the study sponsor.