BEAD Feasibility Study
Does the baby head elevation balloon (Fetal Pillow®) make an emergency caesarean, when the cervix is fully dilated, safer for māmā and pēpi?
What is the BEAD Study?
We are planning a trial, called the BEAD Study, to find out whether using a small, soft inflatable balloon (Fetal Pillow®) at an emergency caesarean section at full dilatation can reduce the risk of injury to the mother’s womb and make the delivery easier and safer for babies. This trial will include 400 patients/māmā and pēpi.
What was the BEAD Feasibility Study?
Before undertaking this trial we needed to conduct the BEAD Feasibility Study to understand the patient experience of being involved in an intrapartum study. The feasibility study helped us identify the best time to approach patients about the study, the type of information patients were happy to have collected about themselves and their baby, what changes we could make to support patients to take part in the study and what factors supported or prevented doctors and midwives contributing to the study.
Eligible patients who were approached in labour about the BEAD Feasibility Study were invited to complete an anonymous survey about their experience and their decision to take part or not take part in the study. Patients who wanted to take part in the randomised controlled trial had the balloon (Fetal Pillow®) placed in the vagina immediately prior to the caesarean section and inflated or not inflated.
Patients who agreed to take part in the feasibility study will also contribute to the main BEAD Study.
Who took part in the BEAD Feasibility Study?
The BEAD Feasibility Study took place at Auckland City Hospital and Middlemore Hospital in New Zealand. This study was for patients who were pregnant at 37 weeks or more with one baby that was head down (cephalic) at the time of birth and needed a caesarean section at full dilatation (when the cervix was 10cm dilated).
What was involved in the BEAD Feasibility Study?
Participants could choose to complete an anonymous survey about their decision to take part in or not take part in, the randomised controlled trial component of the BEAD Feasibility Study. This survey collected information on the patient and whānau experience of the intrapartum consent process as well as barriers and motivators to taking part in research, at the time of labour and birth. Participants who agreed to take part in the randomised controlled trial had the Fetal Pillow® placed immediately prior to their caesarean section and this was either inflated or non-inflated. All other care remained the same. Participants were visited on the postnatal ward by a member of the research team to confirm consent and answer questions about the study. Information was collected about the women until 6 weeks after giving birth and about their baby until their primary hospital discharge. We intend to collect information (about consenting patients) about any preterm births in the next 5 years from maternity records.
Were there any risks?
Previous studies have not shown any harms to mother or baby from use of the Fetal Pillow®.