BEAD information for clinicians and midwives

Background

The BEAD Study is a randomised controlled trial of the Fetal Pillow device at fully dilated caesarean section (CSFD) from 37+ weeks.

The aim of the BEAD Study is to find out whether using the Fetal Pillow® device at the time of CSFD can reduce the risk of maternal injuries (example: uterine extensions).

The incidence of emergency caesarean sections is continuing to rise each year and this includes those performed at full dilatation which account for 2-3% of all births in New Zealand. There can be increased risks for mother and baby with caesarean sections at this stage of labour including difficulty delivering the baby’s head due to it being low and impacted in the pelvis. This increases the risk of uterine extensions which can result in longer operating time and increased blood loss and less commonly neonatal injury or hypoxia. Caesarean section at full dilatation is also associated with an increased risk of preterm birth in a future pregnancy.

There is currently no consensus on the safest and/or most effective strategy to assist with delivery of a deeply impacted fetal head. Current methods include digital vaginal disimapaction, tocolysis and reverse breech extraction.

The Fetal Pillow® is a disposable silicone balloon that is inserted vaginally immediately prior to a CS at full dilatation and inflated to elevate the baby’s head prior to delivery. This device is already widely used in almost all maternity hospitals in Aotearoa New Zealand (along with many in Australia, and some in the US and UK). Although the research to date does not suggest any harms for mother or baby, there is currently insufficient evidence to recommend its use.

The BEAD Study will determine whether use of the Fetal Pillow® at fully dilated caesarean section from 37 weeks provides benefit without harm. We will assess maternal uterine extensions and neonatal outcomes and aim to assess impact on future rates of preterm birth.

Exclusion criteria

• Unable to or do not give consent
• Major congenital anomalies requiring NICU admission or palliative care
• Known stillbirth at decision for caesarean section
• Urgency of caesarean section (as determined by operating surgeon) leading to inadequate time to randomise and place the device

Patients enrolled in other labour trials (such as ARM trial at Auckland Hospital) are potential candidates for our study.

What does BEAD involve for women?

Local clinicians (with support from the BEAD research team) to please approach women in labour who are needing an emergency caesarean section at full dilatation (or are going to theatre for a trial of instrumental delivery) to:

• Invite women to participate and obtain consent AND
• Place the Fetal Pillow® in the vagina immediately prior to their emergency caesarean section and remove the balloon at the end of the procedure.

The anaesthetist will either inflate the balloon (with water) or leave it non-inflated and deflate the balloon immediately after the baby is delivered.

A member of the BEAD Research Team will visit the women and whanau on the postnatal ward and consent to review information relating to the birth and postpartum period for mother and baby.

All eligible birthing women will be invited to complete a short simple survey about their experiences of being approached to take part in the study.

The remainder of clinical care will continue as usual.

Contact

The BEAD Clinical Research Coordinators can be contacted by email on thebeadstudy@auckland.ac.nz or phone 021355828.

For urgent clinical enquiries contact the Principal Investigator Dr. Jordon Wimsett (Jordon.wimsett@auckland.ac.nz or 021355828) or Dr. Lynn Sadler (LynnS@adhb.govt.nz).