Bakri balloon during cesarean delivery for placenta previa

Abstract Objective To determine if the use of a Bakri balloon at cesarean delivery (CD) for placenta previa is associated with a reduced need for additional surgical or pharmacologic measures and less blood loss than usual practices. Methods In a randomized controlled trial, 52 women undergoing CD for placenta previa were randomly allocated 1:1 into an intervention arm (prophylactic Bakri balloon immediately following placental delivery) or a control arm (use of any usual surgical/pharmacologic measures to achieve hemostasis). The primary outcomes were a clinician’s decision to undertake further intervention to control bleeding, and the difference between preoperative and postoperative hemoglobin levels. Results Although fewer women in the intervention group required additional measures to achieve hemostasis during CD, the difference between the groups was not significant (relative risk 0.54; 95% confidence interval, 0.19–1.57). The change in hemoglobin level among women in the intervention arm was also similar to that among controls (2.3 g/dL; 95% confidence interval, –4.4 to 8.9). Conclusion The prophylactic use of a Bakri balloon at CD for placenta previa tended to be of benefit, with no evidence of harm or patient dissatisfaction, but the need for additional medical/surgical measures to control blood loss was not significantly reduced. Australian New Zealand Clinical Trials Registry: ACTRN12613000348752.