Michael M Beckmann1, Jacqueline Chaplin2. 1. Mater Health Services, Brisbane, Australia; Mater Medical Research Institute, Brisbane, Australia. Electronic address: michael.beckmann@mater.org.au. 2. Mater Medical Research Institute, Brisbane, Australia.
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 (2.3g/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.
RCT Entities:
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 (2.3g/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.