OBJECTIVE: To assess the efficacy and safety of condom-loaded Foley's catheter versus Bakri Balloon in the management of primary atonic post partum hemorrhage (PPH) secondary to vaginal delivery. STUDY DESIGN: This study was single blinded randomized controlled trial conducted at Assiut Woman's Health Hospital, Egypt in the period between October 2014 and December 2015. It Comprised 66 women with primary atonic PPH following vaginal delivery. Eligible participants were randomly assigned to Bakri balloon (group A) or condom-loaded Foley's catheter (group B). The primary outcome was the success of tamponade to stop the uterine bleeding without additional surgical interventions. Secondary outcomes included time between insertion and stoppage of the bleeding, the amount of blood transfusion and maternal complications. RESULTS: Both treatment modalities successfully controlled the primary atonic PPH without a statistically significant difference [30/33(91.0%) and 28/33(84.84%), p = .199; respectively]. However; Bakri balloon required shorter time to stop the uterine bleeding (9.09 min vs. 11.76 min, p = .042; respectively). There was no statistically significant difference between both groups regarding postpartum maternal complications, the vital signs, urine output, hemoglobin and hematocrit levels from before to after tamponade insertion. CONCLUSIONS:Condom-loaded Foley's catheter is as effective as Bakri balloon in the management of primary atonic PPH following vaginal delivery but requires a significant bit longer time to stop the attack.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety of condom-loaded Foley's catheter versus Bakri Balloon in the management of primary atonic post partum hemorrhage (PPH) secondary to vaginal delivery. STUDY DESIGN: This study was single blinded randomized controlled trial conducted at Assiut Woman's Health Hospital, Egypt in the period between October 2014 and December 2015. It Comprised 66 women with primary atonic PPH following vaginal delivery. Eligible participants were randomly assigned to Bakri balloon (group A) or condom-loaded Foley's catheter (group B). The primary outcome was the success of tamponade to stop the uterine bleeding without additional surgical interventions. Secondary outcomes included time between insertion and stoppage of the bleeding, the amount of blood transfusion and maternal complications. RESULTS: Both treatment modalities successfully controlled the primary atonic PPH without a statistically significant difference [30/33(91.0%) and 28/33(84.84%), p = .199; respectively]. However; Bakri balloon required shorter time to stop the uterine bleeding (9.09 min vs. 11.76 min, p = .042; respectively). There was no statistically significant difference between both groups regarding postpartum maternal complications, the vital signs, urine output, hemoglobin and hematocrit levels from before to after tamponade insertion. CONCLUSIONS: Condom-loaded Foley's catheter is as effective as Bakri balloon in the management of primary atonic PPH following vaginal delivery but requires a significant bit longer time to stop the attack.
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