ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000410358p

Ethics application status

Submitted, not yet approved

Date submitted

21/02/2017

Date registered

21/03/2017

Date last updated

21/03/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Monitoring fetal movements utilising fetal movement monitoring device named as Fetal Kicks

Scientific title

Investigating the utility of Fetal Kicks to monitor fetal movements in pregnant women who have experienced a reduction in the perception of fetal movements

Secondary ID [1]

NIL known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Pregnancy - Antenatal

Fetal Movement Monitoring

Condition category

Condition code

Reproductive Health and Childbirth

Antenatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will utilise routine cardiotocography (CTG) by obstetrician to monitor the fetal movements of the fetus antenatally. At the same time, a novel device , the Fetal Kicks will be attached to their abdomen to monitor the fetal movement as well. Fetal Kicks utilises a strain gauge sensor to monitor the fetal movements. For this study, Fetal Kicks will not be utilised to guide care and only for passive monitoring. This process will take place for a duration of 30 minutes. Fetal Kicks monitoring will only occur on a single occasion only in each participant.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Cardiotocography (CTG) ,ultrasound based assessment of fetal movement and maternal reporting of fetal movement will be carried out on a single occasion for a duration of 30 minutes at the same time as the intervention device.

Control group

Active

Outcomes

Primary outcome [1]

Correlation between the signals obtained from Fetal Kicks and routine cardiotocography over a similar time period. This will be done electronically utilising cross correlation.

Timepoint [1]

Data is collected immediately at the end of each monitoring period of CTG

Primary outcome [2]

Correlation between the signals obtained from Fetal Kicks and ultrasound imaging. This will be compared utilising cross correlation.

Timepoint [2]

Data is collected immediately at the end of each monitoring period of CTG

Secondary outcome [1]

Patient view on Fetal Kicks (i.e pros, cons, will they recommend it, areas for improvement etc.). This will be measured through a questionnaire designed specifically for the study

Timepoint [1]

Data is collected immediately at the end of each monitoring period of CTG

Secondary outcome [2]

Sensitivity, specificity, negative predictive value and positive predictive values of Fetal Kicks in comparison to CTG

Timepoint [2]

Data is collected immediately at the end of each monitoring period of CTG

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
Have experienced a reduction in the perception of fetal movements from what they are usually used to

Minimum age

18 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Yes

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

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

Type of endpoint/s

Statistical methods / analysis

For the following study, a sample size of 50 was estimated based on similar proof of concept studies. This was based on the assumption that the level of a was set at 0.05 and a power of 90% This was based on an estimated recruitment rate of 55 with non responders of 10%.
For the primary objective, statistical tests will be utilised to test the device agreement with routine CTG for measurement of the fetal movement considered to be the gold standard.
For device concordance, outputs on Fetal Kicks and the CTG, ultrasound and maternal reports of fetal movement will be measured and compared electronically using cross correlation. Signal to Residue Ratio (SRR) will be used to compare similarity and how much different the signal from Fetal Kicks is from the control and a Root Mean Square Error (RMSE) will be used for the error for each point in the plot. For UA, a cross correlation statistic will be utilised.
Measurement of device diagnostic accuracy will be made by calculating the sensitivity, specificity negative predictive value and positive predictive values of Fetal Kicks to regular CTG. This will be done by comparing the assessments by clinicians of the CTGs through the reporting tool provided.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/04/2017

Actual

Date of last participant enrolment

Anticipated

2/04/2018

Actual

Date of last data collection

Anticipated

2/04/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University - Monash Institute of Medical Engineering MIME

Address [1]

20 Research Way, Clayton 3168 VIC

Country [1]

Australia

Primary sponsor type

University

Name

Monash University - Monash Institute of Medical Engineering MIME

Address

20 Research Way, Clayton 3168 VIC

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee A

Ethics committee address [1]

Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2017

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The Fetal Kicks is a novel device developed by Monash MIME to monitor fetal movement. For the following study, the current phase entails a proof of concept in women antenatally to assess the quality of signals obtained on Fetal Kicks. For this, Fetal Kicks will be utilised together with the conventional cardiotocography (CTG) to ascertain the equivalence of Fetal Kicks with conventional fetal movement counting

Aims
1. Accurately corroborating maternal perceptions of movements on the CTG (via sensor imprints) to device captures of fetal movements
2. Accurately corroborating maternal perceptions of movements on the ultrasound (via sensor imprints) to device captures of fetal movements

Research design
The following study is a cross sectional survey with a cohort design. The following design has been chosen as it is considered to be the design of choice in evaluating a diagnostic test- in this case, Fetal Kicks. Utilising the following design, measurements of test accuracy and precision will be carried out on Fetal Kicks in comparison to CTG and conventional fetal movement countings.

Primary Outcomes
1. Correlation between the signals obtained from Fetal Kicks and routine cardiotocography over a similar time period. This will be done electronically utilising cross correlation.
2. Correlation between the information obtained from Fetal Kicks and CTG as interpreted by clinicians. This will be measured on a CTG reporting tool designed specifically for the study. 

Secondary Outcomes:
1. Patient view on Fetal Kicks (i.e pros, cons, will they recommend it, areas for improvement etc.). This will be measured through a questionnaire designed specifically for the study

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Vinayak Smith

Address

Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168

Country

Australia

Phone

+61431330754

Fax

vinayak.smith@monash.edu

Contact person for public queries

Name

Vinayak Smith

Address

Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168

Country

Australia

Phone

+61431330754

Fax

vinayak.smith@monash.edu

Contact person for scientific queries

Name

Vinayak Smith

Address

Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168

Country

Australia

Phone

+61431330754

Fax

vinayak.smith@monash.edu

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23492	Study protocol					372375-(Uploaded-30-04-2024-08-54-25)-Study-related document.docx

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.

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