Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001260819
Ethics application status
Approved
Date submitted
9/06/2021
Date registered
17/09/2021
Date last updated
17/09/2021
Date data sharing statement initially provided
17/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
COntinuous fetal heart rate Monitoring using non-invasive Fetal electrocardiographY 2 (COMFY 2)
Scientific title
COntinuous fetal heart rate Monitoring using non-invasive Fetal electrocardiographY 2 (COMFY 2)
Secondary ID [1] 304442 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
COMFY2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stillbirth 322257 0
Condition category
Condition code
Reproductive Health and Childbirth 319942 319942 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have developed a new device to detect the fetal heart beat, a fetal electrocardiogram (ECG) device. We will assess the accuracy of our fetal ECG in this study. This will involve recruiting 90 women from three gestational age ranges (24-30, 30-36 and more than 36 weeks gestation) for the duration of their in-clinic cardiotocography (CTG) monitoring to ensure we are accurately detecting the fetal heart rate. We will also recruit 90 women during labour to determine the device’s ability to detect the fetal heart and uterine contractions during labour. This will allow us to ensure the fetal ECG device is comfortable and we will be able to optimize its output. Next we will recruit 90 women from across the same 3 gestational ages and assess the fetal ECG over a 24 hour period. Finally, we will perform a cross over study where we will recruit 60 women at term and assess the output from our fetal ECG device over 24 hours then assess the output of the Monica AN24 device (an existing fetal ECG device available for research) to see whether our device more accurately detects the fetal ECG. Our novel device differs compared to the Monica device as our device has one sheet of electrodes and we are using updated algorithms to extract the fetal heart rate. The Monica device has multiple electrodes that are positioned all over the mother's abdomen and uses different algorithms to extract the fetal heartbeat. No additional training is required to position our device or the Monica device. The sensor is placed on the abdomen and the monitor is switched on. We will also replicate these studies in women with twins. This study will occur over 5 years.
Intervention code [1] 320789 0
Diagnosis / Prognosis
Comparator / control treatment
We will also obtain a fetal cardiotocography (CTG) and assess whether our fetal ECG signal is comparable.
Control group
Active

Outcomes
Primary outcome [1] 327813 0
The primary objective of this study is to assess the accuracy of our portable fetal ECG device against the CTG.
Timepoint [1] 327813 0
We will recruit women at various gestations in their pregnancy (24 weeks or more) and obtain a recording of the fetal heart activity and uterine activity during their CTG study.
Primary outcome [2] 328728 0
Assess the length of time that a fetal ECG is detected over a 24 hour period.
Timepoint [2] 328728 0
24 hour time frame
Primary outcome [3] 328729 0
Examine the accuracy of our fetal ECG device over 24 hours compared to the Monica Fetal Monitoring device over 24 hours.
Timepoint [3] 328729 0
24 hours for our fetal ECG device and 24 hours for the Monica.
Secondary outcome [1] 396680 0
The secondary objective will be to examine the accuracy of our fetal ECG over a range of gestational ages.
Timepoint [1] 396680 0
This will be done on all participants at gestations from 24 weeks to term and collected immediately.
Secondary outcome [2] 400151 0
We will assess the acceptability of a wearable fetal ECG device before and after the study using a questionnaire. the questionnaire has been developed specifically for this study.
Timepoint [2] 400151 0
This will occur immediately on recruitment to the study

Eligibility
Key inclusion criteria
We will recruit women from 24 weeks gestation to term with a singleton or twin pregnancy
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with an intellectual or mental impairment

Study design
Purpose of the study
Treatment
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
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 will also assess the accuracy of the fetal heart rate detection of our device over a period of 24 hours. We will also compare its accuracy for detecting a fetal ECG against the Monica device.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2021
Actual
Date of last participant enrolment
Anticipated
16/08/2026
Actual
Date of last data collection
Anticipated
16/08/2026
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19684 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 34315 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 308800 0
Charities/Societies/Foundations
Name [1] 308800 0
The Norman Beischer Medical Research Foundation
Country [1] 308800 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] 309716 0
Hospital
Name [1] 309716 0
Mercy Hospital for Women
Address [1] 309716 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Country [1] 309716 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308715 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 308715 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 308715 0
Australia
Date submitted for ethics approval [1] 308715 0
09/06/2021
Approval date [1] 308715 0
07/09/2021
Ethics approval number [1] 308715 0

Summary
Brief summary
We are hoping to develop an accurate and reliable fetal ECG device. In this application we will examine our fetal ECG device against current technology used, the CTG. We will also examine the accuracy of our device to detect a fetal heart rate over 24 hours. We will compare the accuracy of our device against the Monica device, a fetal ECG available for research purposes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111654 0
Dr Fiona Brownfoot
Address 111654 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Country 111654 0
Australia
Phone 111654 0
+61 38458 4022
Fax 111654 0
Email 111654 0
[email protected]
Contact person for public queries
Name 111655 0
Ms Barbara Doherty
Address 111655 0
Mercy Hospital for Women
163 Studley Road
Heidelberg
Victoria 3084
Country 111655 0
Australia
Phone 111655 0
+61 38458 4444
Fax 111655 0
Email 111655 0
[email protected]
Contact person for scientific queries
Name 111656 0
Mr Emerson Keenan
Address 111656 0
University of Melbourne
Department of Electrical and Electronic Engineering
University of Melbourne
Parkville Vic 3010
Country 111656 0
Australia
Phone 111656 0
+61 38458 4381
Fax 111656 0
Email 111656 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)?
September 2021-September 2031
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 at [email protected]


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.