Trial Review

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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] 291200 0
NIL known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy - Antenatal 302164 0
Fetal Movement Monitoring 302165 0
Condition category
Condition code
Reproductive Health and Childbirth 301775 301775 0 0
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] 297242 0
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] 301169 0
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] 301169 0
Data is collected immediately at the end of each monitoring period of CTG
Primary outcome [2] 301170 0
Correlation between the signals obtained from Fetal Kicks and ultrasound imaging. This will be compared utilising cross correlation.
Timepoint [2] 301170 0
Data is collected immediately at the end of each monitoring period of CTG
Secondary outcome [1] 331942 0
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] 331942 0
Data is collected immediately at the end of each monitoring period of CTG
Secondary outcome [2] 332894 0
Sensitivity, specificity, negative predictive value and positive predictive values of Fetal Kicks in comparison to CTG
Timepoint [2] 332894 0
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7538 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 15362 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 295646 0
University
Name [1] 295646 0
Monash University - Monash Institute of Medical Engineering MIME
Country [1] 295646 0
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] 294534 0
None
Name [1] 294534 0
Address [1] 294534 0
Country [1] 294534 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296964 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 296964 0
Monash Medical Centre, 246 Clayton Road, Clayton VIC 3168
Ethics committee country [1] 296964 0
Australia
Date submitted for ethics approval [1] 296964 0
18/01/2017
Approval date [1] 296964 0
Ethics approval number [1] 296964 0

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 72558 0
Dr Vinayak Smith
Address 72558 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 72558 0
Australia
Phone 72558 0
+61431330754
Fax 72558 0
Email 72558 0
[email protected]
Contact person for public queries
Name 72559 0
Dr Vinayak Smith
Address 72559 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 72559 0
Australia
Phone 72559 0
+61431330754
Fax 72559 0
Email 72559 0
[email protected]
Contact person for scientific queries
Name 72560 0
Dr Vinayak Smith
Address 72560 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 72560 0
Australia
Phone 72560 0
+61431330754
Fax 72560 0
Email 72560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23492Study protocol    372375-(Uploaded-30-04-2024-08-54-25)-Study-related document.docx

Results publications and other study-related documents

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