Early clinical experience with the OB balloon for prophylactic intrauterine tamponade during cesarean section for placenta previa: a prospective multicenter phase II study.
Tanaka Masaaki M, Kato Jun J, Hori Yoshiaki Y, Nakade Kyouhei K et al.
Placenta previa is a major cause of severe postpartum hemorrhage, and effective intraoperative strategies to prevent bleeding during cesarean section remain an important clinical challenge. Intrauterine balloon tamponade has been reported as an effective strategy for hemorrhage control. We developed a novel double-balloon device, the OB balloon, intended for intrauterine tamponade during cesarean section in patients with placenta previa. This study evaluated the safety, feasibility, and clinical effectiveness of the OB balloon. In this prospective multicenter phase II study, 55 patients with placenta previa, including low-lying placenta, underwent cesarean section with prophylactic placement of the OB balloon. Perioperative outcomes, including blood loss, need for additional hemostatic interventions, and device-related complications, were analyzed. Mean blood loss before balloon placement was 1306 g, whereas median blood loss after placement was 70 g. No patient required cesarean hysterectomy or additional surgical or interventional hemostatic procedures after balloon placement. The device was inserted directly through the uterine incision, and both balloons were inflated intraoperatively by the operating surgeon under sterile conditions. Median inflation volumes were 80 mL for the uterine balloon and 50 mL for the vaginal balloon. The balloon was maintained for 12-24 hours and removed without complication. Balloon prolapse occurred in 3.6% of cases. Prophylactic use of the OB balloon during cesarean section for placenta previa was safe, feasible, and associated with reduced blood loss in this cohort. The dual-balloon design provided stable tamponade with a low rate of prolapse and eliminated the need for additional hemostatic interventions.