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.
Keywords
uncontrolled postpartum hemorrhage - uterine balloon tamponade - mechanical properties
- medical device
