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Trial registered on ANZCTR


Registration number
ACTRN12622000251729
Ethics application status
Approved
Date submitted
17/01/2022
Date registered
11/02/2022
Date last updated
8/12/2022
Date data sharing statement initially provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Harnessing technology in labour and birth for women with increased BMI.
Scientific title
Efficacy of harnessing technology in labour and birth for women with increased BMI.
Secondary ID [1] 306224 0
Nil
Universal Trial Number (UTN)
U1111-1273-3013
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex labour and childbirth 324945 0
Obesity 324946 0
Condition category
Condition code
Reproductive Health and Childbirth 322376 322376 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised with consent to either the standard care for fetal monitoring cardiotocograph or the non invasive fetal electrocardiogram (NIFECG). Participants will be monitored throughout labour with the device to which they have been randomised. Midwives at the site will deliver the intervention once in each participant's labour. The time period depends on the length of time it takes each woman to give birth. This is impossible to predict but may last anything from 1 minute to 18 hours. The intervention occurs in the hospital labour wards of the clinical sites.
The key differences in the two devices are the wearables and in the way the data is retrieved.
CTG involves the woman wearing two elastic belts, to each of which a transducer is attached. One is an ultrasound transducer that measures fetal herat via sound waves. The other is a tocodynamometer that measures the pressure of uterine contractions. CTG image is at http://www.mvb-med.ch/Philips_CTG_Avalon_fm30-fr.html
NIFECG uses fetal ECG, maternal ECG to collect data on fetal and maternal heart rates. It also uses electromyography to collect data on uterine contractions by picking up electrical signals from the myometrium. NIFECG image is at https://www.philips.com.au/healthcare/product/HC866488/avalon-beltless-fetal-monitoring-solution
Intervention code [1] 322626 0
Treatment: Devices
Intervention code [2] 322627 0
Diagnosis / Prognosis
Comparator / control treatment
Standard care, continuous fetal monitoring in labour and birth as per protocol with cardiotocograph (CTG). Example guidelines:
NSW Health, Office of Kids and Families 2018, Maternity - Fetal Heart Rate Monitoring Guideline (GL2018_025), NSW Health, Sydney.
Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) 2019, Intrapartum Fetal Surveillance Clinical Guidelines – 4th Edition. RANZCOG, Melbourne.
Control group
Active

Outcomes
Primary outcome [1] 330144 0
Cord blood gas results for all participating women who had an operative birth (#routinely
collected for all operative births including those by caesarean section, forceps and
vacuum extraction). Cord blood gas results determine whether a baby was hypoxic in utero or not. All cord blood gases will be collected from all participants who had an operative birth due to suspected fetal hypoxia. Detection of fetal hypoxia* in women with BMI equal to or greater than 35kg/m2 who had an operative birth (caesarean section, forceps or vacuum extraction) for suspected fetal distress, detected by cord blood gas results.
(*According to cord blood gas analysis (pH, lactate and base excess levels as per hospital protocol).
Timepoint [1] 330144 0
Umbilical cord blood gas results, blood gases collected immediately after the time of birth.
Secondary outcome [1] 405044 0
Barriers and facilitators to upscaling the implementation of NIFECG as standard care for the monitoring of women with BMI of 35 or above in Australia.
Timepoint [1] 405044 0
Post intervention focus groups and/or semi structured
qualitative interviews with midwives and obstetricians, as soon as practicable after the intervention.
Secondary outcome [2] 405045 0
Rate of fetal scalp electrode (FSE) use, derived from routinely collected hospital data
Timepoint [2] 405045 0
During labour and birth. To be analysed from routinely collected data that is collected post intervention.
Secondary outcome [3] 405046 0
Participants’ perceptions of their autonomy and agency during labour and birth, using the Labour Agentry Scale (LAS) (Hodnett and Simmonds-Tropea 1987).
Timepoint [3] 405046 0
Participating women will be invited to complete the LAS at 2-8 weeks postpartum.
Secondary outcome [4] 405047 0
The impact of different continuous electronic fetal monitoring (CEFM) devices on midwifery practice. (Ethnographic observations of 3 hour portions of 30 participating women’s labours).
Timepoint [4] 405047 0
Active 1st stage of labour.

Eligibility
Key inclusion criteria
BMI of 40 or above, or
BMI of 35 or above in the presence of one or more co-morbidities
Equal to or greater than 34 weeks gestation at the time of recruitment
Equal to or greater than 36 weeks at onset of labour
Planning a vaginal birth
Able to read and speak English – (this study does not have adequate budget or resources
to develop multi-lingual consent and information sheets or to provide interpreters at
interviews).
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with a multiple pregnancy (the device is suitable only for singleton pregnancies).
Women who are not being continuously monitored.
Women who are known to be giving birth by planned caesarean section (as labour and
continuous monitoring are not applicable).
Women with a fetus known to be incompatible with life (as this clinical circumstance
brings added burden to the woman, her family and caregivers and is beyond the scope of
this study).
Women who commence labour and give birth prior to 36 weeks’ gestation (as the device
is not registered for use in women of less than 36 weeks’ gestation)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised allocation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our study has three sites available, and we project that we will be able to recruit 150 patients per site (total of 450). The rate of unnecessary unplanned c-sections in our target population is estimated to be 42%, so we have >0.8 power to detect an absolute decrease of 13.2 percentage points (42% to 28.8%) between groups assuming a drop-rate of 10%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/12/2022
Actual
Date of last participant enrolment
Anticipated
30/12/2023
Actual
Date of last data collection
Anticipated
15/01/2024
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 21491 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 21492 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 23694 0
Townsville University Hospital - Douglas
Recruitment postcode(s) [1] 36397 0
2500 - Wollongong
Recruitment postcode(s) [2] 36398 0
3128 - Box Hill
Recruitment postcode(s) [3] 39129 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 310572 0
Commercial sector/Industry
Name [1] 310572 0
Philips Medizin Systeme Boeblingen GmbH
Country [1] 310572 0
Germany
Primary sponsor type
University
Name
University of Technology Sydney
Address
PO Box 123 Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 311751 0
None
Name [1] 311751 0
Address [1] 311751 0
Country [1] 311751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310179 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical HREC
Ethics committee address [1] 310179 0
University of Wollongong,
Northfields Ave,
Wollongong, NSW 2522
Ethics committee country [1] 310179 0
Australia
Date submitted for ethics approval [1] 310179 0
08/02/2022
Approval date [1] 310179 0
30/05/2022
Ethics approval number [1] 310179 0
Ethics committee name [2] 310180 0
University of Technology Sydney HREC
Ethics committee address [2] 310180 0
PO Box 123
Broadway
NSW 2007
Ethics committee country [2] 310180 0
Australia
Date submitted for ethics approval [2] 310180 0
15/02/2022
Approval date [2] 310180 0
Ethics approval number [2] 310180 0

Summary
Brief summary
For women with a BMI>40, or a BMI 30-40 and one or more comorbidities, continuous electronic fetal monitoring via cardiotocograph (CTG) monitoring, is recommended (RANZCOG 2019). 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. A wireless and beltless monitoring device, the non-invasive fetal electrocardiogram (NIFECG) was registered by the Therapeutic Goods Administration (TGA) for clinical use in Australia in 2018.
The aim of this study is to determine how the use of an innovative monitoring technology, NIFECG, in women with increased BMI, compares with the current standard monitoring, CTG in:
• Detection of fetal distress requiring intervention
• Fetal scalp electrode (FSE) use
• Maternal feelings of control and agency during labour and birth
• Capacity for midwives to provide woman-centred care.
Using the results of both the quantitative and qualitative data that will be collected, the study will also explore barriers and facilitators to implementation of the NIFECG as routine care for women with increased BMI. Hybrid RCT Type 1 methodology, following the approach of Curran et al. (2012), uses a hybrid effectiveness-implementation typology. The study design therefore enables a dual focus a priori, testing the effectiveness of a clinical intervention on specified outcomes whilst also synthesising implementation needs.
The RCT will be conducted at three clinical sites in Australia. The sample size is 450 women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116770 0
A/Prof Deborah Fox
Address 116770 0
Collaborative for Midwifery, Child and Family Health,
University of Technology Sydney
PO Box 123 Broadway NSW 2007
Country 116770 0
Australia
Phone 116770 0
+61 02 95147982
Fax 116770 0
Email 116770 0
Deborah.Fox@uts.edu.au
Contact person for public queries
Name 116771 0
A/Prof Deborah Fox
Address 116771 0
Centre for Midwifery, Child and Family Health,
University of Technology Sydney
PO Box 123
Broadway NSW 2007
Country 116771 0
Australia
Phone 116771 0
+61 02 95147982
Fax 116771 0
Email 116771 0
Deborah.Fox@uts.edu.au
Contact person for scientific queries
Name 116772 0
A/Prof Deborah Fox
Address 116772 0
Collaborative for Midwifery, Child and Family Health,
University of Technology Sydney
PO Box 123 Broadway NSW 2007
Country 116772 0
Australia
Phone 116772 0
+61 02 95147982
Fax 116772 0
Email 116772 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
Individual participant data will be aggregated by intervention or control group. Data will not be made publicly available unless a reasonable request is made to the Chief Investigator.


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.