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Trial registered on ANZCTR


Registration number
ACTRN12624001016527
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
22/08/2024
Date last updated
22/08/2024
Date data sharing statement initially provided
22/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Ambulatory fetal movement monitoring device - Fetal Kicks
Scientific title
Investigating the utility of a fetal motion sensor in measuring fetal movements
Secondary ID [1] 312635 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy - Antenatal 333655 0
Ambulatory Fetal Movement Monitoring 333656 0
Condition category
Condition code
Reproductive Health and Childbirth 330343 330343 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is for pregnant women who have normal, uncomplicated pregnancies. Patients will be asked if they wish to participate. They will have the trial explained to them and told that their participation is completely voluntary, they will be reassured that inclusion or not, will have no effect on their medical treatment at any time. Nor will it have any effect on the relationship they have with the hospital staff. As the study relates to fetal movement, no tissue is collected. Participants will be told that they are free to withdraw at any time, and they do not need to provide a reason for withdrawing from the study. If the participant has expressed an interest, she will be given the patient information and made aware there will be no financial incentive for participation. This is a once-off trial, where the patient will undergo overnight monitoring using the Fetal Kicks device from 10pm to 8am.

The device that will be used in this trial is named the Fetal Kicks device. The Fetal Kicks device is an easy to use, wearable, wireless monitoring device for pregnant woman who present reduced fetal movement. The overall feel of the device doesn’t differ much from a normal bandaid. This Fetal Kicks device has a flexible electronic circuit board layer and encapsulated with sweat permeable sports bandage. Underneath the device there is a layer of disposable one-use double-sided medical 3M silicone adhesive. The device is approximately 75mm long, 28mm wide and 2mm.

If participants opt to participate in the trial, they will take the device home to use before bed. The midwife will scan the participant’s abdomen using a handheld ultrasound in a semi-recumbent position for up to 10 minutes to identify the fetus's presentation. After that, the participant will be taught by the study coordinator or midwives to attach the soft Fetal Kicks device(s) to her belly. In short, the protective backing of the adhesive underneath the Fetal Kicks device is peeled off, and it is attached to the prescribed spot on the pregnant woman’s stomach. The soft Fetal Kicks device(s) will be attached to the belly by the participant at home, preferably before 10 pm. After that, the participant will be required to perform activities below:

> Lifting up an object from floor to knee height for 5 times
> Twisting your body left and right for 5 times each
> Bending down for 5 times
> Standing for 2 minutes
> Walking for 2 minutes
> Lying down for 2 minutes
> Sitting for 2 minutes

Following this, the participant will need to continue wearing the device until the next morning when she’s awake preferably after 8 am. The participant can remove the soft Fetal Kicks device(s) when she’s awake. After this study, the participant will have to return the device(s) to the study coordinator / midwives, and a form will be given to her to evaluate her experience with the study process and to provide feedback on the device as well as the aspects which could be improved upon and raise any safety concerns she might have had during the monitoring process

If at any time during the study a participant becomes upset or distressed, they will be encouraged to contact the study coordinator immediately. The research will stop and counselling or other appropriate support will be arranged by the study doctor.
Intervention code [1] 328492 0
Diagnosis / Prognosis
Intervention code [2] 329329 0
Treatment: Devices
Comparator / control treatment
An accelerometer patch will be attached on the participant's chest with double-sided medical 3M silicone adhesive as a comparator. The movement signal that is detected by the accelerometer and Fetal Kicks device within < 2s apart will be considered as maternal movement, whereas movement detected by the Fetal Kicks device but not the accelerometer will be regarded as fetal-related movement.
Control group
Active

Outcomes
Primary outcome [1] 338948 0
Correlation between the signals obtained from Fetal Kicks and accelerometer patch over a similar period to assess the sensitivity of Fetal Kicks sensor.
Timepoint [1] 338948 0
Data is collected immediately at the end of each monitoring period (after participants returned the devices)
Primary outcome [2] 338949 0
Ability of Fetal Kicks device to differentiate Fetal movements and maternal movements
Timepoint [2] 338949 0
Data is collected immediately at the end of each monitoring period (after participants returned the devices)
Secondary outcome [1] 438001 0
Patient view on Fetal Kicks (i.e pros, cons, will they recommend it, areas for improvement etc.).
Timepoint [1] 438001 0
Data is collected immediately at the end of each monitoring period (after participants returned the devices)
Secondary outcome [2] 438597 0
Ability of the Fetal Kicks device to perform over 12 hours
Timepoint [2] 438597 0
Data is collected immediately at the end of each monitoring period (after participants returned the devices)

Eligibility
Key inclusion criteria
> Have a singleton pregnancy
> Should be pregnant and above 28 weeks of pregnancy
> Should be aware of what normal fetal movements are
> No presentation for reduced fetal movements during the current pregnancy.
> No congenital abnormality in the fetus
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
> Women below 18 years of age
> Patients with an intellectual or mental impairment
> People in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process
> People highly dependent on medical care
> Weight >200kg

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
For the following study, a sample size of 300 is considered sufficient, based on expert opinion, to create a working data set which can compare device efficacy and simultaneously be analysed using machine learning techniques to subsequently function as a standalone algorithm to identify fetal movements autonomously.

Demographic data will be expressed using summary statistics utilising parametric procedures. Intraclass correlation coefficients and Bland Altman analysis will be undertaken to assess reliability. Receiver operating characteristic curves will be generated to Machine learning techniques will also be utilised in an attempt to classify.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
2/09/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26872 0
North Shore Private Hospital - St Leonards
Recruitment hospital [2] 26873 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 42935 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 316406 0
Government body
Name [1] 316406 0
NHMRC
Country [1] 316406 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319384 0
Government body
Name [1] 319384 0
North Sydney Local Health District
Address [1] 319384 0
Country [1] 319384 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315203 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315203 0
Ethics committee country [1] 315203 0
Australia
Date submitted for ethics approval [1] 315203 0
22/07/2024
Approval date [1] 315203 0
23/07/2024
Ethics approval number [1] 315203 0

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

Contacts
Principal investigator
Name 133966 0
Prof Jonathan Morris
Address 133966 0
Women and Babies Research, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 133966 0
Australia
Phone 133966 0
+61294362129
Fax 133966 0
Email 133966 0
[email protected]
Contact person for public queries
Name 133967 0
Jonathan Morris
Address 133967 0
Women and Babies Research, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 133967 0
Australia
Phone 133967 0
+61294362129
Fax 133967 0
Email 133967 0
[email protected]
Contact person for scientific queries
Name 133968 0
Jonathan Morris
Address 133968 0
Women and Babies Research, Kolling Institute, Royal North Shore Hospital, St Leonards, NSW, 2065
Country 133968 0
Australia
Phone 133968 0
+61294362129
Fax 133968 0
Email 133968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.