The BEAD Feasibility Study: Baby Head Elevation device at full dilatation caesarean section

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000758606

Acronym

BEAD Feasibility Study

Enrollment

128

Registered

2023-07-12

Start date

2023-08-13

Completion date

2024-08-12

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Age = /> 16 years 2. Singleton pregnancy 3. Gestational age =/> 37 weeks 4. Cephalic presentation 5. Confirmed 10cm cervical dilatation

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).

Outcome results