Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000925549
Ethics application status
Approved
Date submitted
4/12/2023
Date registered
31/07/2024
Date last updated
31/07/2024
Date data sharing statement initially provided
31/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The evaluation of a novel biosensor to continuously monitor human fetal scalp lactate intrapartum
Scientific title
Feasibility and reliability of a novel biosensor for continuous monitoring of fetal scalp lactate during labour and delivery: a phase 1 study
Secondary ID [1] 311108 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FILM1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Birth asphyxia 332263 0
Hypoxic ischaemic encephalopathy 332264 0
Condition category
Condition code
Reproductive Health and Childbirth 328979 328979 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An interventional clinical study to evaluate the feasibility and reliability of a novel new biosensor called DelivAssure.
A fetal scalp electrode will be positioned on the fetal scalp during labour for women who have consented for themselves and their unborn baby to participate in the study. The scalp electrode will be positioned once cervical dilatation is sufficient for application of the DelivAssure device and remain in situ until it is removed either immediately prior to the commencement of skin prepping at Caesarean Section of following crowning of the fetal head in the event of a vaginal birth. Timing of application and removal of the DelivAssure device will be documented in medical records and on the case report form (CRF), including reasons for removal of the device. The fetal scalp electrode will continuously measure and record a signal that will provide information on fetal heart rate and fetal scalp lactate.
The current measurement will be correlated with lactate measurement obtained from a fetal blood sample during labour and also from the umbilical cord at birth. The fetal heart rate recorded from the sensor will be correlated to any fetal heart rate monitoring obtained for clinical reasons. The information recorded by the device will not be provided to clinicians or study participants and will not be used to influence clinical management. Clinicians (medical or nursing obstetric staff) trained in application of the study device and with prior experience applying a fetal scalp electrode will be responsible for application of the study device to the fetal scalp. Non-clinical research personnel will be present to monitor the signal.
Photographs will be obtained of the fetal scalp after delivery and at 4-6 week follow-up
Study participants will be asked to participate in a qualitative interview conducted at 4-6 week intervals.
Intervention code [1] 327560 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336767 0
Feasibility
Timepoint [1] 336767 0
crowning of the fetal head or indicated time of device removal due to other clinical intervention (e.g., surgical delivery)
Primary outcome [2] 336768 0
Reliability
Timepoint [2] 336768 0
from time of application to crowning of the fetal head or indicated time of removal due to other clinical intervention (surgical delivery)
Secondary outcome [1] 429630 0
Concurrent measurement of fetal heart rate and electric current output
Timepoint [1] 429630 0
from time of device application until its removal
Secondary outcome [2] 429631 0
The proportion of time that an electric current is recorded from the DelivAssure device
Timepoint [2] 429631 0
At time of fetal scalp blood sample and/or at time of umbilical cord blood sample at birth
Secondary outcome [3] 429632 0
Fetal heart rate
Timepoint [3] 429632 0
Throughout period of DelivAssure device remaining in situ on fetal head
Secondary outcome [4] 429633 0
Acceptability of device to women in labour
Timepoint [4] 429633 0
4-6 weeks after delivery
Secondary outcome [5] 429634 0
Acceptability of the DelivAssure device to caregivers
Timepoint [5] 429634 0
Completion of study at each recruiting site.
Secondary outcome [6] 430075 0
Blood lactate
Timepoint [6] 430075 0
At time of fetal blood sampling (fetal blood sample) and/or immediately following birth (umbilical cord).
Secondary outcome [7] 430076 0
Fetal heart rate
Timepoint [7] 430076 0
Throughout period of DelivAssure device remaining in situ on fetal head
Secondary outcome [8] 430077 0
Integrity of the fetal scalp
Timepoint [8] 430077 0
Day 1 of life and at review 4-6 weeks after birth.

Eligibility
Key inclusion criteria
Participant
1. Informed written consent, confirmed verbally on admission to Birthing Unit
2. Cervical dilatation sufficient for application of DelivAssure device
3. Established labour
4. Uncomplicated term pregnancy
5. Rupture membranes with clear amniotic fluid
6. No concern over fetal welfare
7. Vaginal birth anticipated
Clinician
1. Involvement in caring for a woman/fetus participating in the FILM1 study
2. Attendance at a focus group or individual interview
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants
1 Anticipated birth within 60 minutes
2. Requirement for fetal scalp clip for fetal monitoring
3. Maternal infections: HIV, Hepatitis C, Hepatitis B positive, Group B streptococcus positive, history of Herpes Simplex Type II
4. Clinical chorioamnionitis as evidenced by maternal temperature >37.50C an/or fetal baseline heart rate >180bpm and/or offensive smellingamniotic fluid
5. Proven or suspected fetal bleeding disorder
6. Prolonged rupture of the membranes (over 12 hours)

Clinicians - no exclusion criteria

Study design
Purpose of the study
Diagnosis
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
First in human fetus study requiring a small sample to establish feasibility and reliability of the device prior to progression to premarket approval studies
Sample size is typical of many first in human studies.
Outcomes will be determined using standard descriptive statistics (proportion) and parametric correlation. Qualitative evaluation of device acceptability will be analysed thematically using the NASSS Framework (Greenhalgh et al, 2018)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 26703 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [2] 26704 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 26705 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 26706 0
North Shore Private Hospital - St Leonards
Recruitment hospital [5] 26707 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 42741 0
6008 - Subiaco
Recruitment postcode(s) [2] 42742 0
3168 - Clayton
Recruitment postcode(s) [3] 42743 0
2065 - St Leonards
Recruitment postcode(s) [4] 42744 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 315364 0
Government body
Name [1] 315364 0
Cooperative Research Centres
Country [1] 315364 0
Australia
Funding source category [2] 315365 0
Commercial sector/Industry
Name [2] 315365 0
VitalTrace Pty Ltd
Country [2] 315365 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
VitalTrace Pty Ltd
Address
43 Action Rd, Malaga, Western Australia, 6090
Country
Australia
Secondary sponsor category [1] 317424 0
None
Name [1] 317424 0
Address [1] 317424 0
Country [1] 317424 0
Other collaborator category [1] 283059 0
University
Name [1] 283059 0
The University of Western Australia
Address [1] 283059 0
Country [1] 283059 0
Australia
Other collaborator category [2] 283060 0
University
Name [2] 283060 0
The University of Sydney
Address [2] 283060 0
Country [2] 283060 0
Australia
Other collaborator category [3] 283061 0
University
Name [3] 283061 0
University of Technology Sydney
Address [3] 283061 0
Country [3] 283061 0
Australia
Other collaborator category [4] 283062 0
University
Name [4] 283062 0
Monash University
Address [4] 283062 0
Country [4] 283062 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314282 0
Women and Newborn Health Service
Ethics committee address [1] 314282 0
Ethics committee country [1] 314282 0
Australia
Date submitted for ethics approval [1] 314282 0
05/12/2023
Approval date [1] 314282 0
02/04/2024
Ethics approval number [1] 314282 0
RGS0000006565

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131050 0
Prof Jane Pillow
Address 131050 0
School of Human Sciences, The University of Western Australia, M309 35 Stirling Hwy, Crawley, 6009, WA
Country 131050 0
Australia
Phone 131050 0
+61417621960
Fax 131050 0
Email 131050 0
[email protected]
Contact person for public queries
Name 131051 0
Jane Pillow
Address 131051 0
School of Human Sciences, The University of Western Australia, M309 35 Stirling Hwy, Crawley, 6009, WA
Country 131051 0
Australia
Phone 131051 0
+61417621960
Fax 131051 0
Email 131051 0
[email protected]
Contact person for scientific queries
Name 131052 0
Jane Pillow
Address 131052 0
School of Human Sciences, The University of Western Australia, M309 35 Stirling Hwy, Crawley, 6009, WA
Country 131052 0
Australia
Phone 131052 0
+61417621960
Fax 131052 0
Email 131052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Interventional study with outcomes blinded to clinicians. No study data will have relevance for IPD analyses


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.