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

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.