Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000185167
Ethics application status
Approved
Date submitted
3/02/2019
Date registered
8/02/2019
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing a comfortable fetal heart rate monitor that can be used by pregnant women
Scientific title
Continuous fetal heart rate monitoring using non-invasive fetal electrocardiography
Secondary ID [1] 297327 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
COMFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stillbirth 311317 0
Condition category
Condition code
Reproductive Health and Childbirth 309951 309951 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are seeing whether we can obtain a reliable fetal ECG using non-invasive monitoring. We will do this by performing an ultrasound to ascertain the fetal position and then place ECG dots (electrodes) over the abdomen of pregnant women. We will obtain around 5 minutes of CTG and fetal ECG recording. Using signal processing techniques we will see whether we can remove interference to obtain a reliable continuous fetal ECG.
Intervention code [1] 313508 0
Diagnosis / Prognosis
Comparator / control treatment
We will also obtain a fetal CTG and assess whether our fetal ECG signal is comparable.
Control group
Active

Outcomes
Primary outcome [1] 318874 0
Fetal heart activity as assessed by ECG.
Timepoint [1] 318874 0
We will recruit 120 women at various gestations in their pregnancy and obtain a recording of the fetal heart activity and uterine activity.
Secondary outcome [1] 366297 0
We will assess whether the fetal position, as assessed by ultrasound, alters the fetal ECG output and see whether we can develop algorithms to correct for this.
Timepoint [1] 366297 0
This will be done on all participants at various gestations and collected immediately.

Eligibility
Key inclusion criteria
We will recruit women from 28 weeks gestation to term with a singleton pregnancy
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Fetal cardiac defects
Patients with an intellectual or mental impairment

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
We will use signal processing techniques to remove interference from the fetal ECG. We will then assess whether the fetal ECG is comparable to the current standard of care, the fetal CTG.

We plan to recruit 120 women with singleton pregnancies over 2 years and believe our sample size is justified
as follows:
1) Whilst 120 is a modest number, it will be sufficient to obtain preliminary data on whether our computational model correctly predicts the observed surface potentials in the cohort. If successful, it will provide evidence that the model has predictive power which can be utilised to improve the reliability of fetal heart rate extraction algorithms.
2) In support of 1, the authors have access to a large existing dataset of NI-FECG recordings with silver standard reference fetal heart rate (manually annotated) which will be used to test the robustness of our model. This dataset can provide evidence of our model’s ability to generalise to novel data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2019
Actual
Date of last participant enrolment
Anticipated
4/02/2021
Actual
Date of last data collection
Anticipated
4/02/2021
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13017 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 25503 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301808 0
Charities/Societies/Foundations
Name [1] 301808 0
Austin Medical Research Foundation
Country [1] 301808 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of Obstetrics and Gynaecology,
The University of Melbourne Level 4
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 301551 0
Hospital
Name [1] 301551 0
Mercy Hospital for Women
Address [1] 301551 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Country [1] 301551 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302514 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 302514 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 302514 0
Australia
Date submitted for ethics approval [1] 302514 0
04/08/2018
Approval date [1] 302514 0
09/10/2018
Ethics approval number [1] 302514 0
2018-046

Summary
Brief summary
We will recruit 120 women with singleton pregnancies without cardiac abnormalities from 28 weeks gestation to term. Each participant will undergo a NI-FECG recording session with concurrently recorded CTG and tocodynamometer to ascertain a gold standard for the fetal heart activity and uterine activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90478 0
Dr Fiona Brownfoot
Address 90478 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Country 90478 0
Australia
Phone 90478 0
+61 3 8458 4022
Fax 90478 0
Email 90478 0
[email protected]
Contact person for public queries
Name 90479 0
Ms Anna Middleton
Address 90479 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Country 90479 0
Australia
Phone 90479 0
+61 3 8458 4444
Fax 90479 0
Email 90479 0
[email protected]
Contact person for scientific queries
Name 90480 0
Mr Emerson Keenan
Address 90480 0
University of Melbourne
Department of Electrical and Electronic Engineering
University of Melbourne
Parkville Vic 3010
Country 90480 0
Australia
Phone 90480 0
+61 3 8458 4022
Fax 90480 0
Email 90480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We would be open to collaborate with others interested in developing a non-invasive fetal ECG. We will share the fetal ECG raw data.
When will data be available (start and end dates)?
February 2020-February 2030.
Available to whom?
To other researchers interested in developing a non-invasive fetal ECG.
Available for what types of analyses?
This will be discussed with interested parties.
How or where can data be obtained?
Through email contact.


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.