A Comparative Analysis of User Experience With Uterine Balloon Devices During Standardized Postpartum Hemorrhage Simulations

Abstract

Background: Maternal mortality remains the greatest global health disparity with postpartum hemorrhage (PPH) the most common cause. Uterine balloon tamponade (UBT) devices offer a highly effective, point of care intervention that does not require complex equipment. However, there are many UBT devices on the market and few studies have compared them in clinical practice. Additionally, no studies have examined differences in user experience between devices. In cases of PPH, it is essential to have simple, easy to use equipment that can be deployed in minutes. Understanding how ease of use compares between devices is critical to informing PPH guidelines and practice. Methods: User experience was assessed with five UBT devices by simulating emergency PPH clinical scenarios with a SynDaver pelvic model. The five devices tested encompassed a range of commercial, low-cost, and improvised devices, including: Ellavi balloon, Bakri balloon, Ebb balloon, Every Second Matters-UBT (ESM-UBT), and an improvised condom balloon. Participants placed and inflated each device in the SynDaver uterus during PPH simulations. Data collected included user subjective experiences reported via surveys and the time and number of attempts required for participants to achieve successful placement. Results: Four key findings were drawn from this study. Firstly, Ellavi balloon was rated to be the simplest, easiest, and fastest device to use overall. Secondly, both Ellavi and the ESM-UBT, lowcost alternatives to expensive commercial devices, were found to be non-inferior with regard to ease of use and may be superior to Bakri balloon. Thirdly, the ESM-UBT was rated higher than the improvised balloon and was faster to assemble and inflate even without simulating one of the greatest differences between the devices, which is that the components for the improvised are often not readily available. Fourthly, the Ebb was fast to use but also more confusing for users with a higher rate of error. Finally, Bakri balloon was not as highly rated as expected given that it is the gold standard. It ranked fourth overall, just above the improvised device. Conclusion: This study provides evidence that devices vary substantially in their user-friendliness and speed at which they can be assembled, placed, and inflated. Given the high cost of commercial devices like Bakri balloon, which is approximately 100x the cost of Ellavi and ESM-UBT, and a climate of rising healthcare costs, these results suggest it may be time to consider adopting less expensive, easier to use devices that have recently come to market.