Comparative Study of the Safety and Efficacy of a Prophylactic Insertion of Dr. Burke's Every Second Matters-Uterine Balloon Tamponade (ESM-UBT) With IM Oxytocin vs. Only IM Oxytocin for the Prevention of Atonic PPH: A Randomized Parallel Group Trial.

Background Uterine balloon tamponade (UBT) has emerged as a minimally invasive and cost-effective technique for managing atonic postpartum hemorrhage (PPH). This study assesses the safety and efficacy of prophylactic Dr. Burke's Every Second Matters-UBT (ESM-UBT) combined with intramuscular (IM) oxytocin compared to IM oxytocin alone in preventing atonic PPH in high-risk women. Methods This randomized parallel-group trial was conducted over 1.5 years at Shri BM Patil Medical College, Hospital, and Research Centre, Vijayapura, Karnataka. A total of 226 women with high-risk pregnancies for atonic PPH were enrolled and randomized into two groups: Group 1 received prophylactic ESM-UBT with IM oxytocin (10 units), while Group 2 received only IM oxytocin. Blood loss was measured using the Brass V drape (Microtrack Surgicals Co., Ahmedabad, Gujarat, India) and additional gauze pad weight assessment. Hemoglobin levels were recorded pre-delivery and 48 hours postpartum. Statistical analysis was performed using IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp., Armonk, NY). Results The prophylactic use of ESM-UBT significantly reduced total blood loss (Mean: 198.7 mL vs. 325.2 mL, p= 0.000001) and post-delivery hemoglobin drop (Group 1: 9.9 g/dL vs. Group 2: 9.2 g/dL, p = 0.0049). Blood loss at 5, 10, and 60 minutes postpartum was consistently lower in the ESM-UBT group (p 0.0001). The additional uterotonics and blood transfusion requirement was significantly higher in the IM oxytocin-only group (p = 0.003, p = 0.013, respectively). Conclusion Prophylactic ESM-UBT significantly reduces blood loss and the need for additional interventions in high-risk women, demonstrating its potential as a vital tool in PPH prevention, particularly in resource-limited settings. Its cost-effectiveness and ease of use make it a feasible global solution for improving maternal outcomes.