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CC BY-NC-ND 4.0 · AJP Rep 2019; 09(04): e376-e383
DOI: 10.1055/s-0039-1697653
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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

Kamyar Mollazadeh-Moghaddam
1   Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts
,
Michelle Dundek
1   Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts
,
Anuj Bellare
1   Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts
,
Anderson Borovac-Pinheiro
1   Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts
2   Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, São Paulo, Brazil
,
Alice Won
1   Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts
,
Thomas F. Burke
1   Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital, Boston, Massachusetts
3   Harvard Medical School, Boston, Massachusetts
4   Harvard T. H. Chan School of Public Health, Boston, Massachusetts
› Author Affiliations
Further Information

Publication History

17 May 2019

16 July 2019

Publication Date:
05 December 2019 (online)

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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
 

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