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Trial registered on ANZCTR


Registration number
ACTRN12624000899549
Ethics application status
Approved
Date submitted
8/07/2024
Date registered
24/07/2024
Date last updated
24/07/2024
Date data sharing statement initially provided
24/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The BEAD Trial: Baby Head Elevation Device Study at full dilatation caesarean section
Scientific title
The BEAD Trial: Baby head elevation device during caesarean section at full cervical dilatation; a multi-centre, double-blinded, placebo-controlled, randomised controlled trial assessing maternal and neonatal morbidity.
Secondary ID [1] 312230 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BEAD Trial
Linked study record
ACTRN12623000758606 is the feasibility study conducted before this full RCT

Health condition
Health condition(s) or problem(s) studied:
Caesarean section at full cervical dilatation 333931 0
Maternal uterine incision extensions 333932 0
Condition category
Condition code
Reproductive Health and Childbirth 330603 330603 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/theatre staff. Device is deflated by anaesthetist/theatre staff after delivery of baby. Device is removed by surgeon at end of operation.
Intervention code [1] 328682 0
Prevention
Comparator / control treatment
Non-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/theatre staff. Device is sham-deflated after delivery of baby by anaesthetist/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] 338351 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.
Timepoint [1] 338351 0
At end of primary caesarean or at end of any return to theatre for repair of original uterine injury
Secondary outcome [1] 435577 0
Major uterine extensions – defined as into surrounding structures (uterine arteries, broad ligament, cervix, vagina, bladder, or ureter).
Timepoint [1] 435577 0
At end of primary caesarean or at end of any return to theatre for repair of original uterine injury
Secondary outcome [2] 435578 0
Incision-to-delivery interval in seconds. This is from time of sharp uterotomy to time of delivery of the neonate.
Timepoint [2] 435578 0
At completion of caesarean birth
Secondary outcome [3] 435580 0
Birth to end of surgery (skin closure) in minutes.
Timepoint [3] 435580 0
At completion of caesarean birth
Secondary outcome [4] 435581 0
Total length of surgery in minutes. From initial knife-to-skin to final skin suture.
Timepoint [4] 435581 0
At completion of caesarean birth
Secondary outcome [5] 436353 0
Estimated blood loss (EBL) in operating theatre in mLs
Timepoint [5] 436353 0
At completion of caesarean birth
Secondary outcome [6] 436354 0
Requirement for a maternal red blood cell (RBC) transfusion.
Timepoint [6] 436354 0
Anytime from post-caesarean birth to primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [7] 436355 0
Maternal intensive care unit (ICU) admission.
Timepoint [7] 436355 0
Anytime from post-caesarean birth to primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [8] 436356 0
Maternal length of stay postpartum (in hours) until discharge to home
Timepoint [8] 436356 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [9] 436357 0
Maternal readmission to hospital within 6 weeks of birth.
Timepoint [9] 436357 0
Six weeks postpartum
Secondary outcome [10] 436358 0
Maternal death within 6 weeks of birth.
Timepoint [10] 436358 0
Six weeks postpartum
Secondary outcome [11] 436359 0
Perinatal death (within 28 days of delivery including intrapartum stillbirth and neonatal death).
Timepoint [11] 436359 0
End of 27th day post birth
Secondary outcome [12] 436360 0
Moderate to severe hypoxic ischemic encephalopathy (HIE). This is classified as Sarnat stage 2 or 3 or requiring treatment with therapeutic hypothermia (cooling).
Timepoint [12] 436360 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [13] 436361 0
Neonatal seizures treated with anti-convulsants.
Timepoint [13] 436361 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [14] 436362 0
Significant neonatal birth injury (any fracture, intracranial haemorrhage, nerve palsy, spinal injury).
Timepoint [14] 436362 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [15] 436363 0
Neonatal hypoxia at birth (APGAR <7 at 5 mins or received cardiac massage).
Timepoint [15] 436363 0
At completion of caesarean birth
Secondary outcome [16] 436364 0
Neonatal intensive care unit (NICU) admission of >/= 24 hours.
Timepoint [16] 436364 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [17] 436365 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 anticonvulsants, significant birth injury (any fracture or nerve palsy or intracranial haemorrhage or spinal injury), or NICU admission >=24 hours.
Timepoint [17] 436365 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [18] 436367 0
Neonatal phototherapy for hyperbilirubinaemia.
Timepoint [18] 436367 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [19] 436368 0
Breastfeeding status at primary hospital discharge (fully or exclusively).
Timepoint [19] 436368 0
Primary hospital discharge
Secondary outcome [20] 436369 0
Neonatal intensive care unit (NICU) length-of-stay in days.
Timepoint [20] 436369 0
Primary hospital discharge
Secondary outcome [21] 436370 0
Impacted fetal head. Described as “a cesarean birth where the obstetrician is unable to deliver the fetal head with their usual delivering hand, and additional maneuvers and/or tocolysis are required to disimpact and deliver the head.”.
Timepoint [21] 436370 0
At completion of caesarean birth
Secondary outcome [22] 436371 0
Perceived degree of difficulty in delivery of fetal head by the operating surgeon. Using a 4 point Likert scale,
Timepoint [22] 436371 0
At completion of caesarean birth
Secondary outcome [23] 436372 0
To undertake a cost effectiveness analysis of the intervention (Fetal Pillow). This will include the cost of the device and hospital care for mother and baby from birth admission to discharge home (from public system perspective).
Timepoint [23] 436372 0
6 weeks post-partum
Secondary outcome [24] 436373 0
Subsequent spontaneous preterm birth (within 5 years of fully dilated Caesarean = index birth).
Timepoint [24] 436373 0
5 years from index birth (inclusion in study).
Secondary outcome [25] 437261 0
Meconium aspiration syndrome (MAS).
Timepoint [25] 437261 0
Primary hospital discharge (usually within 7 days post-caesarean section)
Secondary outcome [26] 437262 0
Worst umbilical cord gas parameter (venous or arterial) - pH <7.10 or base deficit < -12 or lactate >6mmol/L.
Timepoint [26] 437262 0
At completion of caesarean birth
Secondary outcome [27] 437263 0
Proportion of clinicians who used the device and found it helpful.
Timepoint [27] 437263 0
At completion of caesarean birth

Eligibility
Key inclusion criteria
1. Maternal 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 planned 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 v Waitemata).
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/08/2024
Actual
Date of last participant enrolment
Anticipated
13/08/2027
Actual
Date of last data collection
Anticipated
13/08/2032
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 26378 0
New Zealand
State/province [1] 26378 0
Auckland

Funding & Sponsors
Funding source category [1] 316608 0
Government body
Name [1] 316608 0
Health Research Council of New Zealand
Country [1] 316608 0
New Zealand
Funding source category [2] 316816 0
Charities/Societies/Foundations
Name [2] 316816 0
Auckland Medical Research Foundation
Country [2] 316816 0
New Zealand
Funding source category [3] 316892 0
Charities/Societies/Foundations
Name [3] 316892 0
Auckland Hospitals Research and Endowment Fund (AHREF, formerly A+ Trust)
Country [3] 316892 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 319142 0
None
Name [1] 319142 0
Address [1] 319142 0
Country [1] 319142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315394 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 315394 0
https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
Ethics committee country [1] 315394 0
New Zealand
Date submitted for ethics approval [1] 315394 0
04/04/2024
Approval date [1] 315394 0
06/05/2024
Ethics approval number [1] 315394 0

Summary
Brief summary
Each year, 1500 New Zealand women have a Caesarean section after the cervix is fully open, when it is more dangerous. The baby's head is low in the pelvis and delivering it through the abdomen is associated with tearing of the uterus, leading to excessive blood loss, subsequent risk of preterm birth, and injury to the baby's head and brain. These are serious injuries with potential long-term consequences and costs to whanau and the health system. The Fetal Pillow is a disposable inflatable silicon balloon placed in the vagina immediately before Caesarean to elevate the baby's head to reduce the injury risk. Many doctors have started to use it without evidence that it works. We plan to provide the first large, well designed, industry-independent, double-blinded randomised controlled trial evidence to determine whether the Fetal Pillow reduces maternal and neonatal injuries.
Trial website
https://the-bead-feasibility-study.auckland.ac.nz/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134562 0
Dr Lynn Sadler
Address 134562 0
Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand
Country 134562 0
New Zealand
Phone 134562 0
+6421535187
Fax 134562 0
Email 134562 0
[email protected]
Contact person for public queries
Name 134563 0
Lynn Sadler
Address 134563 0
Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand
Country 134563 0
New Zealand
Phone 134563 0
+6421535187
Fax 134563 0
Email 134563 0
[email protected]
Contact person for scientific queries
Name 134564 0
Lynn Sadler
Address 134564 0
Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand
Country 134564 0
New Zealand
Phone 134564 0
+6421535187
Fax 134564 0
Email 134564 0
[email protected]

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 2028, 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, whose proposed use has been approved by an independent review committee identified for this purpose, who provide a data management plan which satisfies New Zealand requirements, and is approved by the Trial Management Group.
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 Lynn Sadler: [email protected]


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.

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