ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypertensive disorders of pregnancy

Chronic hypertension

Preeclampsia

Gestational hypertension

Superimposed preeclampsia

Condition category

Condition code

Cardiovascular

Hypertension

Reproductive Health and Childbirth

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]

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]

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]

- perinatal loss assessed from enrolment till loss of child or birth of child

Primary outcome [2]

- 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]

- 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]

- 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]

- small for gestational age defined as birthweight below the 10th centile. - assessed at delivery, birthweight corrected for gestational age.

Secondary outcome [1]

Rate of composite maternal complications:
- Abruption - assessed using hospital medical records

Timepoint [1]

Rate of composite maternal complications:
- Abruption - enrolment to delivery

Secondary outcome [2]

- HELLP syndrome - assessed using pathology from hospital records

Timepoint [2]

- HELLP syndrome - enrolment to delivery

Secondary outcome [3]

- eclampsia - assessed using hospital medical records

Timepoint [3]

- eclampsia - enrolment to 6 weeks postpartum

Secondary outcome [4]

- transient ischaemic attack or stroke - assessed using assessed using hospital medical records and MRI brain

Timepoint [4]

- transient ischaemic attack or stroke - enrolment to 6 weeks postpartum

Secondary outcome [5]

- pulmonary oedema - assessed using hospital medical records and radiology

Timepoint [5]

- pulmonary oedema - enrolment to 6 weeks postpartum

Secondary outcome [6]

- renal failure, liver involvement, haematological involvement - assessed using pathology from hospital records

Timepoint [6]

- renal failure, liver involvement, haematological involvement - enrolment to delivery

Secondary outcome [7]

- Death - assessed using pathology from hospital records

Timepoint [7]

- Death - enrolment to 6 weeks postpartum

Secondary outcome [8]

- Cost-effectiveness - assessed using pricing for consumables and MBS codes for consultations, in addition to qualitative interviews

Timepoint [8]

- Cost-effectiveness - enrolment to 6 weeks postpartum

Secondary outcome [9]

- compliance - assessed using the application

Timepoint [9]

- compliance - enrolment to 6 weeks postpartum

Secondary outcome [10]

- patient satisfaction - assessed using qualitative interviews and validated questionnaires

Timepoint [10]

- 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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Campbelltown Hospital - Campbelltown

Recruitment hospital [2]

Liverpool Hospital - Liverpool

Recruitment hospital [3]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment postcode(s) [1]

2560 - Campbelltown

Recruitment postcode(s) [2]

2170 - Liverpool

Recruitment postcode(s) [3]

2200 - Bankstown

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Vascular Immunology group

Address [1]

Heart Research Institute, 7 Eliza St, Newtown NSW 2042

Country [1]

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]

Individual

Name [1]

Angela Makris

Address [1]

Department of Nephrology, Liverpool Hospital, Corner of Elizabeth and Goulburn Streets LIVERPOOL NSW 2170

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Annemarie Hennessy

Address [2]

Department of Medicine
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Ethics

Ethics committee address [1]

Liverpool Hospital, Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2020

Approval date [1]

15/04/2021

Ethics approval number [1]

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

Dr Theepika Rajkumar

Address

Macathur Clinical School, Western Sydney University
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560

Country

Australia

Phone

+61 246343000

Fax

Theepika.rajkumar@health.nsw.gov.au

Contact person for public queries

Name

Theepika Rajkumar

Address

Macathur Clinical School, Western Sydney University
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560

Country

Australia

Phone

+61 246343000

Fax

Theepika.rajkumar@health.nsw.gov.au

Contact person for scientific queries

Name

Theepika Rajkumar

Address

Macathur Clinical School, Western Sydney University
Campbelltown Hospital
Therry Road, Campbelltown New South Wales 2560

Country

Australia

Phone

+61 246343000

Fax

Theepika.rajkumar@health.nsw.gov.au

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 theepika.rajkumar@health.nsw.gov.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8375	Study protocol				Study protocol will be available once ethics appro... [More Details]
8376	Informed 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

Source	Title	Year of Publication	DOI
Embase	R emote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).	2023	https://dx.doi.org/10.1186/s13063-023-07321-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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