Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12619000293167
Ethics application status
Approved
Date submitted
20/02/2019
Date registered
26/02/2019
Date last updated
15/12/2021
Date data sharing statement initially provided
26/02/2019
Date results information initially provided
2/03/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Enabling mobility in labour for women with complex pregnancies with beltless TransAbdominal Monitoring (TAM) technology: feasibility of use in Australian clinical setting
Query!
Scientific title
Enabling mobility in labour for women with complex pregnancies with beltless TransAbdominal Monitoring (TAM) technology: feasibility of use in Australian clinical setting
Query!
Secondary ID [1]
297472
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1228-9845
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Maternity - Intrapartum care
311662
0
Query!
Childbirth
311663
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
310284
310284
0
0
Query!
Fetal medicine and complications of pregnancy
Query!
Reproductive Health and Childbirth
310298
310298
0
0
Query!
Childbirth and postnatal care
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Beltless TransAbdominal Monitoring (TAM) The new device enables women to have complete freedom of movement in positioning in labour and birth. TAM uses fetal electrocardiography, maternal electrocardiography and electromyography to detect fetal heart rate, maternal heart rate and uterine activity. From this data, the wellbeing of the fetus may be assessed.
The efficacy of TAM has been proven and the device is TGA approved for use in Australia. This trial aims to explore the feasibility and acceptability of its use in an Australian clinical setting. Women will be recruited and consented in late pregnancy, prior to labour onset. The device is beltless and wireless and comprises 5 small, round adhesive sensors (similar in size to 12 lead ECG sensors). 4 sensors are placed around the umbilicus in a clockwise configuration, and one is placed above the pubic bone. A central 'pod' about the size of a matchbox is placed on the woman's umbilicus. A cover is applied magnetically to this pod, through which the signals are sent wirelessly to the CTG machine. The devices will be applied to the abdomens of participating women by the midwives employed in the birthing unit at the Royal Hospital for Women (RHW), Randwick, NSW, Australia, who are caring for the participating women in labour. The intervention will be delivered once at the onset of established labour and will be removed after the birth of the baby, to a maximum 48 hours. The intervention will take place in the birthing unit of the RHW. TAM will be applied by the midwives caring for the participating women. Women will not require information about applying the device. Women will be supervised and cared for throughout the duration of their labour and duration of use of the intervention.
Intervention adherence: if the device is found to be uncomfortable or unsuitable, it will be removed and the midwife will record the reason for this.
Query!
Intervention code [1]
313724
0
Treatment: Devices
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
319180
0
Composite outcome: The feasibility of using the TAM device for continuous monitoring in the clinical setting: all-cause mortality and morbidity as assessed by data linkage to medical records, and qualitative data, will be synthesised with the NASSS Framework (Greenhalgh et al. BMC Medicine (2018) 16:66), a validated tool for analysing the implementation of new health technologies into clinical settings.
Domains and questions in the NASSS framework include:
Domain 1: the condition
1A. What is the nature of the condition or illness?
1B. What are the relevant co-morbidities?
1C. What are the relevant socio-cultural factors?
Domain 2: the technology
2A. What are the key features of the technology?
2B. What kind of knowledge does the technology bring into play?
2C. What knowledge and/or support is required to use the
technology?
2D. What is the technology supply model?
2E. Who owns the intellectual property (IP) generated by the
technology?
Domain 3: the value proposition and value chain
3A. What is the developer’s business case for the technology
(supply-side value)?
3B. What is its desirability, efficacy, safety and cost-effectiveness
(demand-side value)?
Domain 4: the adopter system
4A. What changes in staff roles, practices and identities are
implied?
4B. What is expected of the patient (and/or immediate carer) —
and is this achievable by and acceptable to them?
4C. What is assumed about the extended network of lay carers?
Domain 5: the organisation(s)
5A. What is the organisation’s capacity to innovate?
5B. How ready is the organisation for this technology-supported
change?
5C. How easy will the adoption and funding decision be?
5D. What changes will be needed in team interactions and
routines?
5E. What work is involved in implementation and who will do it?
Domain 6: the wider system
6A. What is the political context for programme development,
implementation and roll-out?
6B. What is the regulatory context?
6C. What is the position of professional bodies?
6D. What is the socio-cultural context (public perception, interest,
expectation)?
6E. What is the nature and extent of inter-organisational
networking?
Domain 7: Embedding and adaptation over time
7A. How much scope is there for adapting and co-evolving the
technology and the service over time?
7B. How resilient is the organisation to handling critical events and
adapting to unforeseen eventualities?
Query!
Assessment method [1]
319180
0
Query!
Timepoint [1]
319180
0
During intrapartum period, and 4-6 weeks after birth.
Query!
Secondary outcome [1]
367193
0
Mode of birth: normal vaginal birth, emergency caesarean section, instrumental birth by vacuum extraction, instrumental birth by forceps
Query!
Assessment method [1]
367193
0
Query!
Timepoint [1]
367193
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [2]
367281
0
Length of 1st and 2nd stages of labour
Query!
Assessment method [2]
367281
0
Query!
Timepoint [2]
367281
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [3]
367282
0
Epidural use
Query!
Assessment method [3]
367282
0
Query!
Timepoint [3]
367282
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [4]
367283
0
Opioid use
Query!
Assessment method [4]
367283
0
Query!
Timepoint [4]
367283
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [5]
367284
0
Augmentation during labour with intravenous artificial oxytocin
Query!
Assessment method [5]
367284
0
Query!
Timepoint [5]
367284
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [6]
367286
0
Use of scalp lactate
Query!
Assessment method [6]
367286
0
Query!
Timepoint [6]
367286
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [7]
367287
0
Perineal outcomes (episiotomy, 3rd and 4th degree tears)
Query!
Assessment method [7]
367287
0
Query!
Timepoint [7]
367287
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [8]
367288
0
Indication for emergency caesarean section (if applicable)
Query!
Assessment method [8]
367288
0
Query!
Timepoint [8]
367288
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [9]
367289
0
Apgar scores below 7 at 5 minutes
Query!
Assessment method [9]
367289
0
Query!
Timepoint [9]
367289
0
Examination of routinely collected data in birth records of each participating woman after her birth.
Query!
Secondary outcome [10]
367290
0
NICU admission of over 48 hours
Query!
Assessment method [10]
367290
0
Query!
Timepoint [10]
367290
0
Examination of routinely collected data in hospital records of each participating woman after her discharge.
Query!
Secondary outcome [11]
367291
0
Length of stay in hospital
Query!
Assessment method [11]
367291
0
Query!
Timepoint [11]
367291
0
Examination of routinely collected data in hospital records of each participating woman after her discharge.
Query!
Secondary outcome [12]
367292
0
Maternal birth position
Query!
Assessment method [12]
367292
0
Query!
Timepoint [12]
367292
0
Recorded at time of birth by midwife caring for each participating woman. Data will be recorded on a brief 3 question survey provided to the midwife in a pack containing the single use TAM patch device. The survey has been designed specifically for this study, to enable the collection of elements of data not routinely collected. Completed surveys will be collected in a locked box in the birth unit in the clinical site and retrieved by a member of the research team.
The question asked of the midwives will be: 'What position did the woman give birth in? e.g. upright, kneeling, supine, lateral, under shower
Query!
Secondary outcome [13]
367293
0
Discontinuation of TAM use, and reasons for change to other form of monitoring
Query!
Assessment method [13]
367293
0
Query!
Timepoint [13]
367293
0
Recorded at time of birth by midwife caring for each participating woman. Data will be recorded on a brief 3 question survey provided to the midwife in a pack containing the single use TAM patch device. The survey has been designed specifically for this study, to enable the collection of 3 elements of data not routinely collected. Completed surveys will be collected in a locked box in the birth unit in the clinical site and retrieved by a member of the research team.The question asked of the midwives will be: 'If the woman discontinued use of the TAM prior to giving birth, what was the reason for discontinuation, and what other form of fetal monitoring was used thereafter?? (e.g. emergency caesarean section, request for water immersion, skin irritation etc/ cordless CTG, intermittent auscultation with hand held doppler)'
Query!
Secondary outcome [14]
367294
0
Mobility: maternal positions used,
Query!
Assessment method [14]
367294
0
Query!
Timepoint [14]
367294
0
As recorded by midwife caring for participating women, every 30 minutes during labour, on the fetal monitoring paper trace. Midwives at the site suggested that this is the most convenient method, as they are required to sign the trace at the same time.
Query!
Secondary outcome [15]
367295
0
Freedom of movement
Query!
Assessment method [15]
367295
0
Query!
Timepoint [15]
367295
0
4-6 weeks after birth. Women will be interviewed about their ability to move in labour.
Query!
Eligibility
Key inclusion criteria
Singleton pregnancy
Greater than 34 weeks gestation
Planning a vaginal birth
Deemed to require continuous monitoring during the intrapartum period, according to local clinical guidelines (NSW Health 2018)
Able to read and speak English
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Women with multiple pregnancies (the TAM device is suitable only for singleton pregnancies).
Women who plan to use water immersion in a pool or bath tub.
Women at low risk of complications prior to the onset of labour.
Women who are known to be giving birth by planned caesarean section.
Women with a fetus known to be incompatible with life.
Women who commence labour and give birth prior to 34 weeks gestation.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Descriptive statistics will be used to analyse potential trends and identify findings of interest to inform planning for future research. Birth outcomes will be retrieved from routinely collected data:
-Mode of birth – normal vaginal birth, emergency caesarean section, instrumental birth by vacuum extraction, instrumental birth by forceps.
-Length of 1st and 2nd stages of labour
-Epidural use
-Opioid use
-Augmentation during labour with intravenous artificial oxytocin
-Perineal outcomes (episiotomy, 3rd and 4th degree tears)
-Indication for emergency caesarean section (if applicable)
-Apgar scores below 7 at 5 minutes
-NICU admission of over 48 hours
-Length of stay in hospital
-Use of fetal scalp lactate
Data will be entered into REDCap and exported as de-identified csv files for statistical analysis. Only research team members will appropriate permission will be granted log in to REDCap.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/05/2019
Query!
Actual
27/01/2020
Query!
Date of last participant enrolment
Anticipated
31/10/2019
Query!
Actual
14/07/2020
Query!
Date of last data collection
Anticipated
21/12/2019
Query!
Actual
8/09/2020
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
110
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
13215
0
Royal Hospital for Women - Randwick
Query!
Recruitment postcode(s) [1]
25772
0
2031 - Randwick
Query!
Funding & Sponsors
Funding source category [1]
302041
0
Commercial sector/Industry
Query!
Name [1]
302041
0
Philips Healthcare
Query!
Address [1]
302041
0
Philips Medizin Systeme Boeblingen GmbH
Financial Service Center (FSC)
Hewlett-Packard-Str. 2
71034 Boeblingen
Germany
Query!
Country [1]
302041
0
Germany
Query!
Primary sponsor type
University
Query!
Name
University of Technology Sydney
Query!
Address
PO Box 123, Broadway, NSW, 2007
Query!
Country
Australia
Query!
Secondary sponsor category [1]
301842
0
None
Query!
Name [1]
301842
0
Query!
Address [1]
301842
0
Query!
Country [1]
301842
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
302723
0
NSW Health: South Eastern Sydney Local Health District HREC
Query!
Ethics committee address [1]
302723
0
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, RANDWICK NSW 2031
Query!
Ethics committee country [1]
302723
0
Australia
Query!
Date submitted for ethics approval [1]
302723
0
15/03/2019
Query!
Approval date [1]
302723
0
08/05/2019
Query!
Ethics approval number [1]
302723
0
Query!
Ethics committee name [2]
302724
0
University of Technology Sydney HREC
Query!
Ethics committee address [2]
302724
0
PO Box 123, Broadway NSW 2007
Query!
Ethics committee country [2]
302724
0
Australia
Query!
Date submitted for ethics approval [2]
302724
0
15/04/2019
Query!
Approval date [2]
302724
0
15/05/2019
Query!
Ethics approval number [2]
302724
0
Query!
Summary
Brief summary
Women identified as having complex pregnancies are often advised to have continuous intrapartum fetal monitoring – commonly referred to as CTG monitoring. Conventional forms of CTG monitoring require the labouring woman to wear two tight elastic belts around her abdomen and to be tethered to a machine by wiring, thus restricting her mobility during labour and her choice of position whilst giving birth. In the Australian context, this affects over half of the 310,000 women giving birth each year. However, enabling women to have mobility during labour and birth results in a shorter labour, lower likelihood of caesarean section, fewer epidurals as well as providing psychological benefits by strengthening women’s sense of choice and control.
A new wireless and beltless monitoring device, the transabdominal fetal electrocardiogram (referred to herein as TAM) will be released in Australia by Philips Healthcare in early 2019. Although there is a body of international evidence supporting the safety and efficacy of the device, and it has been registered by the Therapeutic Goods Administration (TGA) for clinical use in Australia, little is known about the implementation of TAM in authentic clinical settings. To investigate this, use of the device will initially be trialled in an Australian tertiary maternity care facility. This is the first stage of a broader investigation of the impacts of TAM in clinical practice.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
91166
0
Dr Deborah Fox
Query!
Address
91166
0
University of Technology Sydney
PO Box 123
Broadway NSW 2007
Query!
Country
91166
0
Australia
Query!
Phone
91166
0
+61 2 95147982
Query!
Fax
91166
0
Query!
Email
91166
0
[email protected]
Query!
Contact person for public queries
Name
91167
0
Dr Deborah Fox
Query!
Address
91167
0
University of Technology Sydney
PO Box 123
Broadway NSW 2007
Query!
Country
91167
0
Australia
Query!
Phone
91167
0
+61 2 95147982
Query!
Fax
91167
0
Query!
Email
91167
0
[email protected]
Query!
Contact person for scientific queries
Name
91168
0
Dr Deborah Fox
Query!
Address
91168
0
University of Technology Sydney
PO Box 123
Broadway NSW 2007
Query!
Country
91168
0
Australia
Query!
Phone
91168
0
+61 2 95147982
Query!
Fax
91168
0
Query!
Email
91168
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
This is a feasibility study, there is no comparison group and the participant group is underpowered to provide any conclusions. The data collected will be used to inform the design of future larger studies.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Fox, Coddington, R., & Scarf, V. (2021). Wanting t...
[
More Details
]
377027-(Uploaded-04-12-2021-11-28-43)-Journal results publication.pdf
Documents added automatically
No additional documents have been identified.
Download to PDF