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Trial registered on ANZCTR


Registration number
ACTRN12617000229370
Ethics application status
Approved
Date submitted
8/02/2017
Date registered
13/02/2017
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring fetal heart rate patterns utilising a novel fetal HEArt Rate Device (HEARD)
Scientific title
Investigating the utility of a novel fetal heart rate monitoring device in measuring fetal heart rate patterns
Secondary ID [1] 291119 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy- Antenatal 301948 0
Fetal Heart rate monitoring devices 301949 0
Condition category
Condition code
Reproductive Health and Childbirth 301600 301600 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will have an ultrasound prior to applying the fetal heart rate device (HEARD) to obtain information on location of the fetal back, placental location and amniotic fluid index.
Patients will then have HEARD attached to their abdomen to monitor the fetal hear rate through a number of electrodes to acquire signals using adbominal fetal electrocardiogram. This will take approximately 15 minutes
Intervention code [1] 297103 0
Not applicable
Comparator / control treatment
No control group is required for this trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301000 0
Correlation between the signals obtained from HEARD and routine cardiotocography over a similar time period. This will be done electronically utilising cross correlation.
Timepoint [1] 301000 0
Data is collected immediately at the end of each monitoring period of CTG
Primary outcome [2] 301001 0
Correlation between the information obtained from HEARD and CTG as interpreted by clinicians. This will be measured on a CTG reporting tool designed specifically for the study. This information includes the baseline , variability, presence and type of decelerations , accelerations and uterine contractions.
Timepoint [2] 301001 0
Data is collected immediately at the end of each monitoring period of CTG
Secondary outcome [1] 331397 0
Patient view on HEARD (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] 331397 0
Data is collected immediately at the end of each monitoring period of HEARD.

Eligibility
Key inclusion criteria
Should be above 24 weeks of pregnancy
Should have a valid indication for antenatal fetal hear rate monitoring as part of their pregnancy management
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
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
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, various measures of signal quality (i.e SQI )will be utilised to quantify the signal quality across each electrode. ANOVA will be utilised to compare the differences across each electrode to determine the highest measure of quality, Regression will be utilised to measure the effect of placental location, fetal back position and amniotic fluid index on signal quality.

For the secondary objectives, information of the views of the patients and clinicians will be analysed using descriptive statistics



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/05/2017
Actual
20/02/2018
Date of last participant enrolment
Anticipated
31/07/2019
Actual
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
50
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7443 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 15257 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 295558 0
University
Name [1] 295558 0
Monash University
Country [1] 295558 0
Australia
Primary sponsor type
University
Name
Monash University Department of Obstetrics and Gynaecology
Address
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 294379 0
Hospital
Name [1] 294379 0
Monash Health
Address [1] 294379 0
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country [1] 294379 0
Australia
Secondary sponsor category [2] 294384 0
Commercial sector/Industry
Name [2] 294384 0
BIORITHM
Address [2] 294384 0
93A Lorong Tanggam

Singapore 798775
Country [2] 294384 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296879 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 296879 0
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Ethics committee country [1] 296879 0
Australia
Date submitted for ethics approval [1] 296879 0
18/01/2017
Approval date [1] 296879 0
28/04/2017
Ethics approval number [1] 296879 0

Summary
Brief summary
The fetal heart rate device (HEARD) is a novel device developed by BIORITHM, a medical technology company, to assess fetal heart rate. For the following study, the current phase entails a proof of concept in women antenatally to assess the quality of signals obtained on HEARD.

Aims
1. Examine the signal quality of fetal electrocardiogram signals obtained on various electrodes
2. Elicit patient opinion about utilising HEARD ( i.e. What do patients think?)

Research design
The following study is a cross sectional survey with a cohort design.

Methods
Primary outcomes:
1. Quantifying signal quality across various electrodes utilising HEARD
2. Correlation between signal quality and placental location, fetal back position and amniotic fluid index

Secondary Outcomes
1. Patient views on HEARD (i.e pros, cons, will they recommend it)
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1697 1697 0 0
/AnzctrAttachments/372314-HREC Review Final Approval and SSA Final Approval (local projects only) clean.pdf (Ethics approval)
Attachments [2] 2935 2935 0 0
/AnzctrAttachments/372314-20180727154310081.pdf (Ethics approval)

Contacts
Principal investigator
Name 72314 0
Dr Vinayak Smith
Address 72314 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 72314 0
Australia
Phone 72314 0
+61431330754
Fax 72314 0
Email 72314 0
[email protected]
Contact person for public queries
Name 72315 0
Vinayak Smith
Address 72315 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 72315 0
Australia
Phone 72315 0
+61335345145
Fax 72315 0
Email 72315 0
[email protected]
Contact person for scientific queries
Name 72316 0
Euan Morrison Wallace
Address 72316 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre, 246 Clayton Road
Clayton, VIC 3168
Country 72316 0
Australia
Phone 72316 0
+61335345145
Fax 72316 0
Email 72316 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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