The BEAD Trial: Baby Head Elevation Device Study at full dilatation caesarean section

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000899549

Acronym

BEAD Trial

Enrollment

170

Registered

2024-07-24

Start date

2024-08-13

Completion date

2027-08-13

Last updated

2026-06-08

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, 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.

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/theatre staff. Device is deflated by anaesthetist/theatre staff after delivery of baby. 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. Maternal 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 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).

Outcome results