A RANDOMIZED CONTROLLED TRIAL COMPARING THE EFFICACY OF SR CANNULA VERSUS FOLEY BALLOON IN THE MANAGEMENT OF POSTPARTUM HEMORRHAGE FOLLOWING VAGINAL DELIVERY

Abstract

Background:
Postpartum hemorrhage (PPH) remains a major cause of maternal mortality, particularly in low- and middle-income countries. While intrauterine tamponade using a Foley balloon is a well-established second-line therapy for atonic PPH, novel devices like the SR Cannula offer an alternative approach using negative pressure to achieve faster and more effective hemostasis.

Objective:
To compare the efficacy and safety of the SR Cannula with the Foley Balloon catheter in achieving hemostasis in women with atonic PPH unresponsive to first-line uterotonics following vaginal delivery.

Methods:
This single-center, prospective, randomized controlled superiority trial enrolled 100 women with atonic PPH after vaginal delivery. Participants were randomized in a 1:1 ratio to receive either SR Cannula (n=50) or Foley Balloon (n=50). The primary outcome was the proportion achieving hemostasis within 15 minutes. Secondary outcomes included time to hemostasis, blood loss volume, need for surgical intervention, hemoglobin drop, transfusion requirement, complications, patient comfort, and provider ease-of-use. Data were analyzed using Chi-square and t-tests as appropriate.

Results:
Hemostasis within 15 minutes was achieved in 94% of the SR Cannula group versus 78% in the Foley Balloon group (p = 0.03). Mean time to hemostasis was significantly shorter in the SR group (6.5 ± 2.1 min vs. 9.4 ± 3.2 min; p < 0.001). The SR group experienced significantly less blood loss (190 ± 65 mL vs. 310 ± 85 mL; p < 0.001), fewer transfusions (20% vs. 36%; p = 0.04), and lower surgical escalation (6% vs. 20%; p = 0.04). Overall complication rates were lower in the SR group (4% vs. 12%), and both patient-reported comfort and provider ease-of-use scores favored the SR Cannula (p < 0.001).

Conclusion:
The SR Cannula demonstrated superior efficacy and faster control of atonic PPH compared to the Foley Balloon, with reduced blood loss, surgical interventions, and higher user satisfaction. These findings support its use as a safe and effective second-line option for PPH management. Further multicenter validation is warranted to assess generalizability and long-term outcomes.