The prophylactic use of a Bakri balloon for women undergoing caesarean section for placenta praevia – a randomised controlled trial

For women randomised to the Bakri arm, the Bakri device package is opened following delivery of placenta and the stopcock removed from the inflation port at the end of the device. The balloon should be placed (un-inflated) in the uterine cavity. Using a long Harrison forcep the inflation port end of the balloon device should be fed through the cervix from above and retrieved by an assistant (non-sterile) vaginally. The stopcock is then to be re-attached to the inflation port by the assistant. Meanwhile the first layer of closure of the uterine incision should be undertaken. Following this, 100ml of sterile water should be inflated into the Bakri balloon. The second layer uterine closure should now be performed taking care not to damage the underlying semi-inflated balloon device. After 2 layer uterine closure, the balloon device should be further inflated (up to a maximum total instilled volume of no more than 500ml) until the uterus is ‘firm’. In the event that the clinician is concerned regarding bleeding, any and all alternative surgical and/or pharmacological measures of achieving haemostasis can now be employed. This may include (but is not limited to) increased rate/duration/concentration of Syntocinon infusion, Misoprostol, Ergometrine, B-lynch or other compression suture, Ergometrine, PGF2-alpha, ligation of uterine/ovarian/internal iliac arteries, hysterectomy. At conclusion of the caesarean section, the surgeon should perform a vaginal examination to confirm that the balloon is in the uterine cavity. A Betadine soaked 1-inch vaginal pack should be introduced to reduce the risk of the balloon being expelled into the vagina. The urethral Foley catheter is to remain in situ until Bakri removed and subsequent vaginal loss assessed. The balloon device is to remain in-situ for no less than 17 hours and no more than 23 hours. The Bakri balloon should be deflated fully, but remain in-situ (deflated) for a further 1 hour to observe for ongoing blood loss in the Bakri collection bag. After 1 hour, the vaginal pack should be removed and the deflated Bakri balloon removed. Subsequent vaginal loss should be recorded up to 36 hours post-birth.