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Trial registered on ANZCTR


Registration number
ACTRN12619000293167
Ethics application status
Approved
Date submitted
20/02/2019
Date registered
26/02/2019
Date last updated
2/03/2021
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
Scientific title
Enabling mobility in labour for women with complex pregnancies with beltless TransAbdominal Monitoring (TAM) technology: feasibility of use in Australian clinical setting
Secondary ID [1] 297472 0
Nil known
Universal Trial Number (UTN)
U1111-1228-9845
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternity - Intrapartum care 311662 0
Childbirth 311663 0
Condition category
Condition code
Reproductive Health and Childbirth 310284 310284 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 310298 310298 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313724 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

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?
Timepoint [1] 319180 0
During intrapartum period, and 4-6 weeks after birth.
Secondary outcome [1] 367193 0
Mode of birth: normal vaginal birth, emergency caesarean section, instrumental birth by vacuum extraction, instrumental birth by forceps




Timepoint [1] 367193 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [2] 367281 0
Length of 1st and 2nd stages of labour
Timepoint [2] 367281 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [3] 367282 0
Epidural use
Timepoint [3] 367282 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [4] 367283 0
Opioid use
Timepoint [4] 367283 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [5] 367284 0
Augmentation during labour with intravenous artificial oxytocin
Timepoint [5] 367284 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [6] 367286 0
Use of scalp lactate
Timepoint [6] 367286 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [7] 367287 0
Perineal outcomes (episiotomy, 3rd and 4th degree tears)
Timepoint [7] 367287 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [8] 367288 0
Indication for emergency caesarean section (if applicable)
Timepoint [8] 367288 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [9] 367289 0
Apgar scores below 7 at 5 minutes
Timepoint [9] 367289 0
Examination of routinely collected data in birth records of each participating woman after her birth.
Secondary outcome [10] 367290 0
NICU admission of over 48 hours

Timepoint [10] 367290 0
Examination of routinely collected data in hospital records of each participating woman after her discharge.
Secondary outcome [11] 367291 0
Length of stay in hospital
Timepoint [11] 367291 0
Examination of routinely collected data in hospital records of each participating woman after her discharge.
Secondary outcome [12] 367292 0
Maternal birth position
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

Secondary outcome [13] 367293 0
Discontinuation of TAM use, and reasons for change to other form of monitoring
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)'
Secondary outcome [14] 367294 0
Mobility: maternal positions used,
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.
Secondary outcome [15] 367295 0
Freedom of movement
Timepoint [15] 367295 0
4-6 weeks after birth. Women will be interviewed about their ability to move in labour.

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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13215 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 25772 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 302041 0
Commercial sector/Industry
Name [1] 302041 0
Philips Healthcare
Address [1] 302041 0
Philips Medizin Systeme Boeblingen GmbH
Financial Service Center (FSC)
Hewlett-Packard-Str. 2
71034 Boeblingen
Germany
Country [1] 302041 0
Germany
Primary sponsor type
University
Name
University of Technology Sydney
Address
PO Box 123, Broadway, NSW, 2007
Country
Australia
Secondary sponsor category [1] 301842 0
None
Name [1] 301842 0
Address [1] 301842 0
Country [1] 301842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302723 0
NSW Health: South Eastern Sydney Local Health District HREC
Ethics committee address [1] 302723 0
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, RANDWICK NSW 2031
Ethics committee country [1] 302723 0
Australia
Date submitted for ethics approval [1] 302723 0
15/03/2019
Approval date [1] 302723 0
08/05/2019
Ethics approval number [1] 302723 0
Ethics committee name [2] 302724 0
University of Technology Sydney HREC
Ethics committee address [2] 302724 0
PO Box 123, Broadway NSW 2007
Ethics committee country [2] 302724 0
Australia
Date submitted for ethics approval [2] 302724 0
15/04/2019
Approval date [2] 302724 0
15/05/2019
Ethics approval number [2] 302724 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91166 0
Dr Deborah Fox
Address 91166 0
University of Technology Sydney
PO Box 123
Broadway NSW 2007
Country 91166 0
Australia
Phone 91166 0
+61 2 95147982
Fax 91166 0
Email 91166 0
Deborah.Fox@uts.edu.au
Contact person for public queries
Name 91167 0
Dr Deborah Fox
Address 91167 0
University of Technology Sydney
PO Box 123
Broadway NSW 2007
Country 91167 0
Australia
Phone 91167 0
+61 2 95147982
Fax 91167 0
Email 91167 0
Deborah.Fox@uts.edu.au
Contact person for scientific queries
Name 91168 0
Dr Deborah Fox
Address 91168 0
University of Technology Sydney
PO Box 123
Broadway NSW 2007
Country 91168 0
Australia
Phone 91168 0
+61 2 95147982
Fax 91168 0
Email 91168 0
Deborah.Fox@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary