Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000758606
Ethics application status
Approved
Date submitted
21/06/2023
Date registered
12/07/2023
Date last updated
10/09/2023
Date data sharing statement initially provided
12/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The BEAD Feasibility Study: Baby Head Elevation device at full dilatation caesarean section
Scientific title
The BEAD Feasibility Study: a two-site, randomised placebo-controlled trial of the Fetal Pillow at fully dilated caesarean section delivery to determine feasibility for recruitment to the BEAD Trial
Secondary ID [1] 309678 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BEAD Feasibility Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caesarean section at full dilatation 330037 0
Maternal uterine incision extensions 330038 0
Condition category
Condition code
Reproductive Health and Childbirth 326945 326945 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inflation group:
Fetal Pillow placed in the vagina (under the baby's head) by operating surgeon, immediately prior to caesarean section at full dilatation. Device is inflated with 180mL sterile water by the anaesthetist. Device is deflated after delivery of baby by anaesthetist. Device is removed by surgeon at end of operation.
Intervention code [1] 326122 0
Prevention
Comparator / control treatment
Sham-inflation group:
Fetal Pillow placed in the vagina (under the baby's head) by operating surgeon, immediately prior to caesarean section at full dilatation. Device is sham-inflated by the anaesthetist. Device is sham-deflated after delivery of baby by anaesthetist. Device is removed by surgeon at end of operation.
(Sham-inflation: using 3-way tap to deliver 180mL (3 syringes) out of the bag into the syringe and back into the bag. No fluid will go into the device).
Control group
Placebo

Outcomes
Primary outcome [1] 334785 0
Total number of women recruited in the second six months of the Feasibility Study. Recruitment is defined as consent, randomisation and receipt of intervention.
Assessed from data collected on the abbreviated consent form and in the electronic randomisation database.
Timepoint [1] 334785 0
Starting from six months after commencement of study and ending twelve months after start of recruitment
Secondary outcome [1] 422075 0
To identify which women (by ethnicity and recruitment site) are willing to participate in a randomised trial of Fetal Pillow use at caesarean section at full dilatation. Assessed by agreement to participate (signed consent form and completion of study-specific questionnaire) and participant demographics (via data collection forms).
Timepoint [1] 422075 0
Twelve months after commencing recruitment.
Secondary outcome [2] 422076 0
To identify if patients provide full consent for study participation following intrapartum consent. Assessed by completion of signed consent form.
Timepoint [2] 422076 0
Within seven days after caesarean section
Secondary outcome [3] 422077 0
To identify if participants consent to the collection of each of maternal, neonatal and future pregnancy data. Assessed via completion of signed consent form.
Timepoint [3] 422077 0
Within seven days after caesarean section
Secondary outcome [4] 422078 0
To identify the barriers and enablers to trial participation by participant via a study specific questionnaire.
Timepoint [4] 422078 0
Within seven days after caesarean section
Secondary outcome [5] 422079 0
To identify the barriers and enablers to trial participation by research staff, medical professional and recruiting site status via face-to-face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team.
Timepoint [5] 422079 0
By six and twelve months after commencing recruitment.
Secondary outcome [6] 422080 0
To assess whether the quality of resources including written information and videos for patients are suitable. This will be assessed via a study specific questionnaire.
Timepoint [6] 422080 0
Within seven days after caesarean section
Secondary outcome [7] 422081 0
To assess of adequacy of clinician training for involvement in the study via face-to-face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team.
Timepoint [7] 422081 0
By six and twelve months after commencing recruitment.
Secondary outcome [8] 422082 0
To identify the proportion of the 'BEAD Study Template' (Template tool) that is completed. This is a form completed by the surgeon at the end of the operation assessing uterine extensions, operating time and feedback on Fetal Pillow use. Assessed by review of study form.
Timepoint [8] 422082 0
By twelve months after start of recruitment.
Secondary outcome [9] 422083 0
To undertake a qualitative analysis of/understand the intrapartum consent experiences of patients approached in this study. This will be assessed via a study specific questionnaire.
Timepoint [9] 422083 0
Within seven days after caesarean section
Secondary outcome [10] 423168 0
Any extension of the maternal uterine incision. This includes any extension of the initial uterotomy. The uterotomy is the intentional, usually sharp incision into the uterus, which is followed by lateral or cephalo-caudal blunt extension generated by traction with two fingers pulling in opposite directions. Extension of the initial uterotomy includes sharp, and inadvertent extension. In sharp extension, the uterotomy is enlarged by sharp incision into a T, a J or U -shape or laterally and undertaken after difficulty delivering the head is encountered. Inadvertent extension may occur laterally or inferiorly and may involve the uterine arteries, broad ligament, lower segment, cervix, vagina, bladder, or ureter. Inclusion of any of these structures (including caused by sharp incision) will be included as part of this outcome.
Assessed by completion of the Template Tool form and review of hospital records.
Timepoint [10] 423168 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [11] 423169 0
Major uterine extensions – defined as into surrounding structures (uterine arteries, broad ligament, cervix, vagina, bladder, or ureter).
This will be recorded visually and in writing on the Template tool form and hospital records will also be reviewed.
Timepoint [11] 423169 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [12] 423170 0
Incision-to-delivery interval in seconds. This is from time of uterotomy to time of delivery of the neonate. This will be recorded on the Template tool form.
Timepoint [12] 423170 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [13] 423171 0
Birth to end of surgery (skin closure) in minutes.
Assessed from hospital records/routinely collected data.
Timepoint [13] 423171 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [14] 423188 0
Total length of surgery in minutes. From initial knife-to-skin to final skin suture.
Assessed from hospital records/routinely collected hospital data.
Timepoint [14] 423188 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [15] 423189 0
Estimated blood loss (EBL) in operating theatre in mLs
Blood loss is weighed in theatre and documented in hospital records.
Timepoint [15] 423189 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [16] 423190 0
Requirement for a maternal red blood cell (RBC) transfusion. Assessed by review of hospital records.
Timepoint [16] 423190 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [17] 423191 0
Maternal intensive care unit (ICU) admission. Assessed by review of hospital records.
Timepoint [17] 423191 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [18] 423192 0
Maternal length of stay postpartum in hours. Assessed by review of hospital records.
Timepoint [18] 423192 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [19] 423194 0
Perinatal death (within 28 days of delivery and during primary hospital admission).
Timepoint [19] 423194 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [20] 423195 0
Moderate to severe hypoxic ischemic encephalopathy (HIE). This is classified as Sarnat stage 2 or 3 or requiring treatment with therapeutic hypothermia (cooling). Assessed by review of hospital and neonatal unit records.
Timepoint [20] 423195 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [21] 423196 0
Neonatal seizures treated with anti-convulsants. Assessed by review of hospital and neonatal unit records.
Timepoint [21] 423196 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [22] 423197 0
Significant neonatal birth injury (any fracture, intracranial haemorrhage, nerve palsy, spinal injury). Assessed by review of hospital and neonatal unit records.
Timepoint [22] 423197 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [23] 423198 0
Neonatal hypoxia at birth (APGAR <7 at 5 mins or received cardiac massage). Assessed by review of hospital and neonatal unit records.
Timepoint [23] 423198 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [24] 423201 0
Neonatal intensive care unit (NICU) admission of >/= 24 hours. Assessed by review of hospital and neonatal unit records.
Timepoint [24] 423201 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [25] 423202 0
Meconium aspiration syndrome (MAS). Assessed by review of hospital and neonatal unit records.
Timepoint [25] 423202 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [26] 423203 0
Composite neonatal outcome: any of perinatal death (intrapartum stillbirth or neonatal death before primary discharge), moderate to severe HIE or treatment with therapeutic hypothermia, seizures treated by an anticonvulsants, significant birth injury (any fracture or nerve palsy or intracranial haemorrhage or spinal injury), or NICU admission >=24 hours).
Timepoint [26] 423203 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [27] 423206 0
Phototherapy for hyperbilirubinaemia. Assessed by review of hospital and neonatal unit records.
Timepoint [27] 423206 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [28] 423207 0
Breastfeeding status at primary hospital discharge (fully or exclusively). Assessed by review of hospital and neonatal unit records.
Timepoint [28] 423207 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [29] 423208 0
Neonatal intensive care unit (NICU) length-of-stay in days. Assessed by review of hospital and neonatal unit records
Timepoint [29] 423208 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [30] 423209 0
Manoeuvres required for impacted fetal head and frequency of these as recorded on Template Tool form or in hospital records.
Timepoint [30] 423209 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [31] 423210 0
Perceived degree of difficulty of delivery of fetal head by the operating surgeon. Using a 4 point Likert scale, recorded on the Template Tool form.
Timepoint [31] 423210 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [32] 423211 0
Cost effectiveness of Fetal Pillow use from a hospital perspective. Assessed using hospital coding information and linkage to hospital financial records.
Timepoint [32] 423211 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [33] 423215 0
Preterm birth (and spontaneous preterm birth) (<37 weeks) in the next pregnancy within 5 years of index birth. Measured by merge with national birthing data using coding for gestation and induction of labour and elective or emergency caesarean section.
Timepoint [33] 423215 0
5 years from index birth (inclusion in study).
Secondary outcome [34] 423681 0
To assess whether the quality of resources including written information and videos for clinicians are suitable. This will be assessed via face-to-face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team and/or study specific questionnaire.
Timepoint [34] 423681 0
By six and twelve months after start of recruitment
Secondary outcome [35] 423682 0
To undertake a qualitative analysis of/understand the intrapartum consent experiences of clinicians. This will be assessed via face-to-face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team and/or study specific questionnaire.
Timepoint [35] 423682 0
By six and twelve months after start of recruitment
Secondary outcome [36] 426554 0
Umbilical cord pH and lactates (venous and arterial). Assessed by review of hospital records.
Timepoint [36] 426554 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [37] 426555 0
Maternal readmission within 6 weeks of birth. Assessed by review of hospital records.
Timepoint [37] 426555 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [38] 426556 0
Maternal death within 6 weeks of birth. Assessed by review of hospital records.
Timepoint [38] 426556 0
Cumulative data will be assessed at the conclusion of the study.

Eligibility
Key inclusion criteria
1. Age = /> 16 years
2. Singleton pregnancy
3. Gestational age =/> 37 weeks
4. Cephalic presentation
5. Confirmed 10cm cervical dilatation
Minimum age
16 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to or don’t give consent
2. Major congenital anomalies requiring NICU admission or palliative care
3. Known stillbirth at decision for caesarean section
4. Urgency of caesarean section (as determined by operating surgeon) leading to inadequate time to randomise and place the device).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation will be completed immediately prior to Caesarean by a staff member who is not the operating surgeon or surgical assistant. Randomisation will be carried out using the web-based (online) REDCap platform.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women will be randomly assigned (using online REDCap platform) to the inflation or sham-inflation group with a 1:1 ratio. The randomisation will be stratified by parity (nulliparous v multiparous) and recruitment site (Auckland v Middlemore).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed as single group, not by study treatment group.

Descriptive statistics will be used for demographics and other baseline data.

Recruitment will be calculated as number of participants recruited of the number of individuals identified as eligible and the number of individuals approached. This will be reported for the whole study population and by groups – ethnicity and recruitment site (Auckland Hospital and Middlemore).

Descriptive summary statistics will be used for all secondary outcomes.

Qualitative methods such as Clarke and Braun thematic analysis will be used to assess enablers and barriers to trial participation and to explore intrapartum consent experiences.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
13/08/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
14/09/2024
Actual
Sample size
Target
50
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 25546 0
New Zealand
State/province [1] 25546 0
Auckland

Funding & Sponsors
Funding source category [1] 313870 0
Charities/Societies/Foundations
Name [1] 313870 0
Health Research Council New Zealand
Country [1] 313870 0
New Zealand
Funding source category [2] 314220 0
Charities/Societies/Foundations
Name [2] 314220 0
Mercia Barnes Trust
Country [2] 314220 0
New Zealand
Primary sponsor type
University
Name
Waipapa Taumata Rau | The University of Auckland
Address
Department of Obstetrics and Gynaecology
Faculty of Medical and Health Sciences
Building 507
28 Park Ave
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 315711 0
None
Name [1] 315711 0
Address [1] 315711 0
Country [1] 315711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313019 0
Northern A Health and Disability Committee
Ethics committee address [1] 313019 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 313019 0
New Zealand
Date submitted for ethics approval [1] 313019 0
09/03/2023
Approval date [1] 313019 0
08/05/2023
Ethics approval number [1] 313019 0

Summary
Brief summary
Each year in New Zealand (NZ) around 1500-2000 babies are born by an emergency caesarean section in the second stage of labour (10 cm dilated). This accounts for around 3% of all births. A caesarean section at this time carries increased risks of injury for mother and baby as the baby’s head is often deep in the pelvis. Potential injuries include incision extension tears of the uterus (sometimes into the vagina) and injury to nearby organs (example the bladder or ureter) with subsequent increased bleeding, operating time, and risk of preterm birth in subsequent pregnancies. Difficulty in delivering the baby can lead to neonatal injury and admission to baby intensive care unit.
The Fetal Pillow® (CooperSurgical), is a disposable inflatable medical device, placed in the vagina at the time of caesarean section and already used widely across New Zealand. Limited research suggests this may be beneficial in aiding safe delivery of baby, but the findings of studies to date are not consistent.
The BEAD (Baby head ElevAtion Device) Feasibility Study will take place at two maternity units over a 12 month period to inform the recruitment strategy and trial processes of a planned, larger BEAD Trial - a two-centre, placebo-controlled, double blinded, randomised trial in Auckland New Zealand. We anticipate that clinical outcomes of the BEAD Feasibility Study will contribute to the BEAD Trial. It will assess the effect of inflating the Fetal Pillow® at a fully dilated caesarean section to improve outcomes for the mother and baby.
Trial website
https://the-bead-feasibility-study.auckland.ac.nz/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126702 0
Dr Jordon Wimsett
Address 126702 0
Department of Obstetrics and Gynaecology
Faculty of Medical and Health Sciences
University of Auckland

Level 1
Building 507
28 Park Road
Grafton
Auckland
1023
Country 126702 0
New Zealand
Phone 126702 0
+64 21355828
Fax 126702 0
Email 126702 0
jordon.wimsett@auckland.ac.nz
Contact person for public queries
Name 126703 0
Dr Jordon Wimsett
Address 126703 0
Department of Obstetrics and Gynaecology
Faculty of Medical and Health Sciences
University of Auckland

Level 1
Building 507
28 Park Road
Grafton
Auckland
1023
Country 126703 0
New Zealand
Phone 126703 0
+64 21355828
Fax 126703 0
Email 126703 0
jordon.wimsett@auckland.ac.nz
Contact person for scientific queries
Name 126704 0
Dr Jordon Wimsett
Address 126704 0
Department of Obstetrics and Gynaecology
Faculty of Medical and Health Sciences
University of Auckland

Level 1
Building 507
28 Park Road
Grafton
Auckland
1023
Country 126704 0
New Zealand
Phone 126704 0
+64 21355828
Fax 126704 0
Email 126704 0
jordon.wimsett@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results.
When will data be available (start and end dates)?
Immediately following publication which is anticipated to occur after 2024, no end date determined.
Available to whom?
The de-identified data that support the findings of this study will be made available upon request to researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Available for what types of analyses?
Any purpose which has received approval from an independent review committee, and is approved by the Trial Management Group.
How or where can data be obtained?
Access subject to approvals by Trial Management Group. Contact via Jordon Wimsett: jordon.wimsett@auckland.ac.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19184Study protocol    will be published 385911-(Uploaded-04-09-2023-11-13-11)-Study-related document.pdf



Results publications and other study-related documents

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