Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000439448p
Ethics application status
Submitted, not yet approved
Date submitted
16/04/2025
Date registered
12/05/2025
Date last updated
12/05/2025
Date data sharing statement initially provided
12/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Pulsenmore’s home ultrasound technology in monitoring high-risk pregnancies
Scientific title
Clinical implementation of Pulsenmore’s home ultrasound technology for remote monitoring of high-risk pregnancies in women at 26 weeks of gestation at Gold Coast University Hospital
Secondary ID [1] 314224 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 337324 0
Small for gestational age fetus 337325 0
High-risk pregnancy 337129 0
Condition category
Condition code
Reproductive Health and Childbirth 333553 333553 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 333708 333708 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulsenmore's Home Ultrasound: a self-operated, clinician-guided home ultrasound device designed for single use and has a total of 150 minutes of scan video and the mobile app is available for iOS and Android smartphones and be downloaded free of charge. The device comprises a handheld, portable ultrasound transducer integrated with a smartphone application for users and a clinician web-viewer dashboard.

The user's smartphone is attached to a cradle on the transducer, functioning as a probe while leveraging its power supply, processing capabilities, and communication features. The device is currently being adopted in Israel, Germany, Switzerland, Brazil, and the USA for clinical purpose.

The handheld ultrasound enables pregnant women to connect their personal smartphones to a dedicated device and application, allowing them to perform ultrasound imaging scans from the comfort of their homes. These scans are transmitted seamlessly to a remote hospital / clinic for analysis and evaluation, focusing on essential fetal vitality parameters such as amniotic fluid, fetal heart rate and movements. The results are then communicated back to the patients, fostering a continuous and personalized healthcare experience.

The use of the device is intended and only permitted to use together with the guidance and oversight of a healthcare professional. The device does not replace any treatment or advice to be provided by healthcare professional. No content or information that may be available through the device constitutes or should be substituted for health, medical or other professional advice. Therefore, for this study, women will maintain their standard antenatal care and only the Clinician-guided mode will be utilized.

As this is a new workflow in Australia, this trial is not intended to replace any current care with the woman; the remote monitoring will be an additional surveillance.

After randomization for intervention group and receiving the device, participants will be instructed to download the Pulsenmore application in their smartphones and will receive direct instructions on how to use the device and perform the scan (the in-person training will be delivered by the research sonographer using standardized instructions of use).

The first appointment will be booked one week after enrolment. For this first and following appointments, a unique procedure key or link will be generated for the patient from the Clinician Dashboard and will allow the participant to connect in the Clinician-guided mode. The QR code or SMS link will only be available for the appointments booked and will be sent to the participants by e-mail or as a text message. Without the QR code or link, participants will not be able use the device.

The participants should scan the QR code or click on the link to connect to the application and to start their appointments. The scan will be completed by the participants during the appointment and will be guided by the research sonographer and research clinician. Each participant may have up to five guided appointments, depending on the gestational age at enrolment and the time spent for scanning, and the time interval between appointments will be determined by clinical judgement.

The telehealth appointment involves interactions through the device platform (Clinician Dashboard), where the participant engages with the sonographer, who will guide them in performing the scan. The scan report will then be reviewed by a Maternal-Fetal Medicine consultant, who will communicate the results and provide further advice to the participant.
Intervention code [1] 330835 0
Treatment: Devices
Comparator / control treatment
Standard routine antenatal care in accordance with local and national guidelines.

Standard care: Routine appointments with the midwifery and obstetric teams; ultrasound scans, including first and second trimester morphology scans and any additional scans to assess fetal growth; and routine laboratory examinations.
Control group
Active

Outcomes
Primary outcome [1] 341132 0
feasibility of the device - composite outcome
Timepoint [1] 341132 0
Baseline survey: to be completed during recruitment into the Pulsenmore study. Exit survey can be completed between the final telehealth appointment and up to four weeks after birth.
Secondary outcome [1] 446389 0
Success rate in relation to image and video quality in the examinations performed by the pregnant women.
Timepoint [1] 446389 0
At every appointment throughout the study

Eligibility
Key inclusion criteria
-Age above 18 years old
-Singleton pregnancies
-Gestational age greater than or equal to 26 weeks
-Body Mass Index < 40kg/m2
-Presence of the following clinical/obstetric conditions:
o Type 1 diabetes mellitus
o Small for gestational age fetus and normal Dopplers
o Previous history of stillbirth
o Second presentation for reduced fetal movement.
-Able to provide an Informed Consent signed.
-No prior experience with the Pulsenmore device
-Full understanding on how the scan should be performed.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-Age below 18 years old
-Body Mass Index above 40kg/m2
-Multiple pregnancies
-Pregnancy complicated by major fetal anomaly or genetic syndrome.
-Women incapable of giving valid consent and performing the scan, such as diminished understanding, non-English speaking and interpreter unavailable, and acute mental health concerns
The study will not exclude participants from culturally and linguistically diverse backgrounds.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
29/04/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27785 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 43974 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 318741 0
Other
Name [1] 318741 0
Gold Coast University Hospital - Maternal Fetal Medicine Research Group.
Country [1] 318741 0
Australia
Primary sponsor type
Other
Name
This research is a site initiate study within the Maternal Fetal Medicine Research Group
Address
Country
Australia
Secondary sponsor category [1] 321178 0
None
Name [1] 321178 0
Address [1] 321178 0
Country [1] 321178 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317355 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 317355 0
Ethics committee country [1] 317355 0
Australia
Date submitted for ethics approval [1] 317355 0
12/03/2025
Approval date [1] 317355 0
Ethics approval number [1] 317355 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140782 0
Prof Fabricio da Silva Costa
Address 140782 0
Maternal-Fetal Medicine Unit, Gold Coast University Hospital. Address: 1 Hospital Boulevard, Southport, 4215, Gold Coast, Queensland
Country 140782 0
Australia
Phone 140782 0
+61 0756871160
Fax 140782 0
Email 140782 0
[email protected]
Contact person for public queries
Name 140783 0
Cristiane de Freitas Paganoti
Address 140783 0
Maternal-Fetal Medicine Unit, Gold Coast University Hospital. Address: 1 Hospital Boulevard, Southport, 4215, Gold Coast, Queensland
Country 140783 0
Australia
Phone 140783 0
+61 07 56871131
Fax 140783 0
Email 140783 0
[email protected]
Contact person for scientific queries
Name 140784 0
Cristiane de Freitas Paganoti
Address 140784 0
Maternal-Fetal Medicine Unit, Gold Coast University Hospital. Address: 1 Hospital Boulevard, Southport, 4215, Gold Coast, Queensland
Country 140784 0
Australia
Phone 140784 0
+61 07 56871131
Fax 140784 0
Email 140784 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.