Mechanical Properties of the Every Second Matters for Mothers-Uterine Balloon Tamponade (ESM-UBT) Device: In Vitro Tests

Abstract

Objective Postpartum hemorrhage (PPH) is the most common cause of maternal mortality and morbidity worldwide, most of which occurs in resource-poor settings. Placement of a uterine balloon may be life-saving in uncontrolled PPH. The Every Second Matters for Mothers-Uterine Balloon Tamponade (ESM-UBT) device is an ultra-low-cost uterine balloon designed for global access. The purpose of this study was to evaluate the mechanical properties of the ESM-UBT device. Study design Intraluminal pressures, diameters, and burst volumes of condom uterine balloons and Foley catheter balloons of ESM-UBT devices were measured in open air and inside uterus models. Condom uterine balloons were tested with uterus model sizes of 100, 250, and 500mL. The condom-catheter O-ring attachment tensile strength was also evaluated. Results All 28 samples of ESM-UBT condom uterine balloons maintained their integrity for at least 3 hours when subjected to pressures of 200 mm Hg or greater across each of the tested uterine volumes. No Foley catheter balloons burst after instillation of 30mL, O-rings withstood forces of 15.4 ± 2.1 N, and condom uterine balloons stretched to 35.8 ± 2.1 cm without loss of integrity. Conclusion The mechanical properties of the ESM-UBT device make it attractive for scale across resource-poor settings.

Reply

“…Finally, it is false that condoms explode after being filled with more than 250À300 mL. A recent in vitro study 5 concluded that intraluminal pressure of condoms remains stable with instillation of saline between 300 mL and 1200 mL, a volume that has also been reported in in vivo studies. Importantly, in this study, no condoms burst with volumes 5000 mL of saline.…”

Cost of managing atonic postpartum haemorrhage with uterine balloon tamponade devices in public health settings of Maharashtra, India: an economic microcosting study

“…The Ministry of Health and Family Welfare, Government of India is assessing the most cost-effective UBT device for atonic PPH management in the public health system given the emerging evidence for relatively low cost ESM-UBT alternative. [19][20][21] The policy decision to make a UBT device available for PPH management across health facilities will have associated cost and health outcome implications. This study aimed to calculate public health system cost of atonic PPH management with SOC, that is, condom-UBT recommended by the 2015 Indian guidelines for PPH management with similar projections for ESM-UBT and another globally used Bakri-UBT device.…”

Impact of the introduction of a low‐cost uterine balloon tamponade (ESM‐UBT) device for managing severe postpartum hemorrhage in India: A comparative before‐and‐after study

“…To date, no before‐and‐after study has evaluated the impact of introducing UBT for the management of severe PPH in low‐ and/or middle‐income countries. Since commercial UBT devices are unaffordable in most resource‐limited settings, our team addressed this problem by developing the “Every Second Matters for Mothers and Babies‐Uterine Balloon Tamponade” (ESM‐UBT) device 18–22 . The ESM‐UBT device is an ultra‐low‐cost, high‐quality, US FDA approved, easy to use condom‐catheter UBT, which is as efficacious and safe as a Bakri balloon for treating PPH 14,23 …”

“…Since commercial UBT devices are unaffordable in most resource-limited settings, our team addressed this problem by developing the "Every Second Matters for Mothers and Babies-Uterine Balloon Tamponade" (ESM-UBT) device. [18][19][20][21][22] The ESM-UBT device is an ultra-low-cost, highquality, US FDA approved, easy to use condom-catheter UBT, which is as efficacious and safe as a Bakri balloon for treating PPH. 14,23 The aim of this study was to evaluate the impact of introducing the ESM-UBT device for managing severe PPH in health facilities in India on the rates of PPH-related maternal death and invasive procedures.…”