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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
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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.
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Secondary ID [1]
312230
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
BEAD Trial
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Linked study record
ACTRN12623000758606 is the feasibility study conducted before this full RCT
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Health condition
Health condition(s) or problem(s) studied:
Caesarean section at full cervical dilatation
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Maternal uterine incision extensions
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Condition category
Condition code
Reproductive Health and Childbirth
330603
330603
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328682
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Prevention
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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).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Assessed by completion of the study-specific Template Tool form and review of hospital records.
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Timepoint [1]
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At end of primary caesarean or at end of any return to theatre for repair of original uterine injury
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Secondary outcome [1]
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Major uterine extensions – defined as into surrounding structures (uterine arteries, broad ligament, cervix, vagina, bladder, or ureter).
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Assessment method [1]
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Assessed by completion of the study-specific Template Tool form and review of hospital records.
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Timepoint [1]
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At end of primary caesarean or at end of any return to theatre for repair of original uterine injury
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Secondary outcome [2]
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Incision-to-delivery interval in seconds. This is from time of sharp uterotomy to time of delivery of the neonate.
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Assessment method [2]
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This will be recorded on the study-specific Template tool form and/or on the anaesthetic theatre record.
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Timepoint [2]
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At completion of caesarean birth
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Secondary outcome [3]
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Birth to end of surgery (skin closure) in minutes.
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Assessment method [3]
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Assessed from hospital medical records/routinely collected data.
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Timepoint [3]
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At completion of caesarean birth
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Secondary outcome [4]
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Total length of surgery in minutes. From initial knife-to-skin to final skin suture.
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Assessment method [4]
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Assessed from hospital records/routinely collected hospital data.
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Timepoint [4]
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At completion of caesarean birth
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Secondary outcome [5]
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Estimated blood loss (EBL) in operating theatre in mLs
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Assessment method [5]
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Blood loss is weighed in theatre and documented in hospital medical records.
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Timepoint [5]
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At completion of caesarean birth
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Secondary outcome [6]
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Requirement for a maternal red blood cell (RBC) transfusion.
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Assessment method [6]
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Assessed by review of hospital medical records.
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Timepoint [6]
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Anytime from post-caesarean birth to primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [7]
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Maternal intensive care unit (ICU) admission.
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Assessment method [7]
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Assessed by review of hospital medical records.
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Timepoint [7]
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Anytime from post-caesarean birth to primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [8]
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Maternal length of stay postpartum (in hours) until discharge to home
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Assessment method [8]
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Assessed by review of hospital medical records.
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Timepoint [8]
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [9]
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Maternal readmission to hospital within 6 weeks of birth.
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Assessment method [9]
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Assessed by review of hospital medical records.
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Timepoint [9]
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Six weeks postpartum
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Secondary outcome [10]
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Maternal death within 6 weeks of birth.
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Assessment method [10]
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Assessed by review of hospital medical records.
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Timepoint [10]
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Six weeks postpartum
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Secondary outcome [11]
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Perinatal death (within 28 days of delivery including intrapartum stillbirth and neonatal death).
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Assessment method [11]
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Assessed by review of hospital medical records.
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Timepoint [11]
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End of 27th day post birth
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Secondary outcome [12]
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Moderate to severe hypoxic ischemic encephalopathy (HIE). This is classified as Sarnat stage 2 or 3 or requiring treatment with therapeutic hypothermia (cooling).
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Assessment method [12]
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Assessed by review of hospital and neonatal unit records.
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Timepoint [12]
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [13]
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Neonatal seizures treated with anti-convulsants.
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Assessment method [13]
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Assessed by review of hospital and neonatal unit records.
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Timepoint [13]
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [14]
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Significant neonatal birth injury (any fracture, intracranial haemorrhage, nerve palsy, spinal injury).
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Assessment method [14]
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Assessed by review of hospital and neonatal unit records.
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Timepoint [14]
436362
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [15]
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Neonatal hypoxia at birth (APGAR <7 at 5 mins or received cardiac massage).
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Assessment method [15]
436363
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Assessed by review of hospital and neonatal unit records.
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Timepoint [15]
436363
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At completion of caesarean birth
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Secondary outcome [16]
436364
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Neonatal intensive care unit (NICU) admission of >/= 24 hours.
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Assessment method [16]
436364
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Assessed by review of hospital and neonatal unit records.
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Timepoint [16]
436364
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [17]
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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.
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Assessment method [17]
436365
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Assessed by review of hospital and neonatal unit records.
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Timepoint [17]
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [18]
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Neonatal phototherapy for hyperbilirubinaemia.
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Assessment method [18]
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Assessed by review of hospital and neonatal unit records.
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Timepoint [18]
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [19]
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Breastfeeding status at primary hospital discharge (fully or exclusively).
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Assessment method [19]
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Assessed by review of hospital and neonatal unit records
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Timepoint [19]
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Primary hospital discharge
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Secondary outcome [20]
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Neonatal intensive care unit (NICU) length-of-stay in days.
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Assessment method [20]
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Assessed by review of hospital and neonatal unit records
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Timepoint [20]
436369
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Primary hospital discharge
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Secondary outcome [21]
436370
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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.”.
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Assessment method [21]
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Recorded on study-specific Template Tool form and check in hospital medical records.
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Timepoint [21]
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At completion of caesarean birth
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Secondary outcome [22]
436371
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Perceived degree of difficulty in delivery of fetal head by the operating surgeon. Using a 4 point Likert scale,
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Assessment method [22]
436371
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Recorded on the study-specific Template Tool form.
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Timepoint [22]
436371
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At completion of caesarean birth
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Secondary outcome [23]
436372
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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).
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Assessment method [23]
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Assessed using hospital coding information and linkage to hospital financial records.
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Timepoint [23]
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6 weeks post-partum
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Secondary outcome [24]
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Subsequent spontaneous preterm birth (within 5 years of fully dilated Caesarean = index birth).
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Assessment method [24]
436373
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Measured by merge with national maternity dataset (MAT) and National Minimum dataset (NMDS) using ICD10 coding. Definition of spontaneous preterm birth is gestation<37 without induction of labour or elective caesarean section, unless either of these is associated with a diagnosis of preterm premature rupture of membranes (PPROM).
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Timepoint [24]
436373
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5 years from index birth (inclusion in study).
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Secondary outcome [25]
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Meconium aspiration syndrome (MAS).
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Assessment method [25]
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Assessed by review of hospital and neonatal unit records.
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Timepoint [25]
437261
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Primary hospital discharge (usually within 7 days post-caesarean section)
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Secondary outcome [26]
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Worst umbilical cord gas parameter (venous or arterial) - pH <7.10 or base deficit < -12 or lactate >6mmol/L.
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Assessment method [26]
437262
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Assessed by review of hospital records.
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Timepoint [26]
437262
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At completion of caesarean birth
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Secondary outcome [27]
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Proportion of clinicians who used the device and found it helpful.
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Assessment method [27]
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Recorded on study-specific Template Tool form.
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Timepoint [27]
437263
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At completion of caesarean birth
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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
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Minimum age
16
Years
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Maximum age
60
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
13/08/2024
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Actual
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Date of last participant enrolment
Anticipated
13/08/2027
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Actual
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Date of last data collection
Anticipated
13/08/2032
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26378
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New Zealand
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State/province [1]
26378
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Auckland
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Funding & Sponsors
Funding source category [1]
316608
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Government body
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Name [1]
316608
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Health Research Council of New Zealand
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Address [1]
316608
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Country [1]
316608
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New Zealand
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Auckland Medical Research Foundation
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Address [2]
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Country [2]
316816
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New Zealand
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Funding source category [3]
316892
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Charities/Societies/Foundations
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Name [3]
316892
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Auckland Hospitals Research and Endowment Fund (AHREF, formerly A+ Trust)
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Address [3]
316892
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Country [3]
316892
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
319142
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Address [1]
319142
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Country [1]
319142
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315394
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
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Ethics committee country [1]
315394
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New Zealand
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Date submitted for ethics approval [1]
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04/04/2024
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Approval date [1]
315394
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06/05/2024
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Ethics approval number [1]
315394
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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.
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Trial website
https://the-bead-feasibility-study.auckland.ac.nz/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Lynn Sadler
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Address
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Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand
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Country
134562
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New Zealand
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Phone
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+6421535187
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Lynn Sadler
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Address
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Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand
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Country
134563
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New Zealand
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Phone
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+6421535187
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Fax
134563
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Email
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[email protected]
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Contact person for scientific queries
Name
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Lynn Sadler
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Address
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Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand
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Country
134564
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New Zealand
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Phone
134564
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+6421535187
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Fax
134564
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual participant data underlying published results.
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When will data be available (start and end dates)?
Immediately following publication which is anticipated to occur after 2028, no end date determined.
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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.
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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.
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How or where can data be obtained?
Access subject to approvals by Trial Management Group. Contact via Lynn Sadler:
[email protected]
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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.
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