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

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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.

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          Global, regional, and national levels and causes of maternal mortality during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

          Nicholas J. Kassebaum, Amelia Bertozzi-Villa, Megan S Coggeshall … (2014)
          The fifth Millennium Development Goal (MDG 5) established the goal of a 75% reduction in the maternal mortality ratio (MMR; number of maternal deaths per 100,000 livebirths) between 1990 and 2015. We aimed to measure levels and track trends in maternal mortality, the key causes contributing to maternal death, and timing of maternal death with respect to delivery. We used robust statistical methods including the Cause of Death Ensemble model (CODEm) to analyse a database of data for 7065 site-years and estimate the number of maternal deaths from all causes in 188 countries between 1990 and 2013. We estimated the number of pregnancy-related deaths caused by HIV on the basis of a systematic review of the relative risk of dying during pregnancy for HIV-positive women compared with HIV-negative women. We also estimated the fraction of these deaths aggravated by pregnancy on the basis of a systematic review. To estimate the numbers of maternal deaths due to nine different causes, we identified 61 sources from a systematic review and 943 site-years of vital registration data. We also did a systematic review of reports about the timing of maternal death, identifying 142 sources to use in our analysis. We developed estimates for each country for 1990-2013 using Bayesian meta-regression. We estimated 95% uncertainty intervals (UIs) for all values. 292,982 (95% UI 261,017-327,792) maternal deaths occurred in 2013, compared with 376,034 (343,483-407,574) in 1990. The global annual rate of change in the MMR was -0·3% (-1·1 to 0·6) from 1990 to 2003, and -2·7% (-3·9 to -1·5) from 2003 to 2013, with evidence of continued acceleration. MMRs reduced consistently in south, east, and southeast Asia between 1990 and 2013, but maternal deaths increased in much of sub-Saharan Africa during the 1990s. 2070 (1290-2866) maternal deaths were related to HIV in 2013, 0·4% (0·2-0·6) of the global total. MMR was highest in the oldest age groups in both 1990 and 2013. In 2013, most deaths occurred intrapartum or postpartum. Causes varied by region and between 1990 and 2013. We recorded substantial variation in the MMR by country in 2013, from 956·8 (685·1-1262·8) in South Sudan to 2·4 (1·6-3·6) in Iceland. Global rates of change suggest that only 16 countries will achieve the MDG 5 target by 2015. Accelerated reductions since the Millennium Declaration in 2000 coincide with increased development assistance for maternal, newborn, and child health. Setting of targets and associated interventions for after 2015 will need careful consideration of regions that are making slow progress, such as west and central Africa. Bill & Melinda Gates Foundation. Copyright © 2014 Elsevier Ltd. All rights reserved.
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            New WHO recommendations on prevention and treatment of postpartum hemorrhage.

            Özge Tunçalp, João Souza, Ahmet Metin Gülmezoglu (2013)
            Improving health care for women during childbirth in order to prevent and treat postpartum hemorrhage (PPH) is an essential step toward achieving Millennium Development Goal 5. In March 2012, WHO held a Technical Consultation on the Prevention and Treatment of Postpartum Haemorrhage to review current evidence and to update previously published PPH guidelines. The present paper provides an overview of the most recent WHO guidelines for both prevention and treatment of PPH, with an emphasis on the key messages and changes.
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              Balloon tamponade in the management of postpartum haemorrhage: a review.

              C Georgiou (2009)
              Obstetric haemorrhage is a significant contributor to worldwide maternal morbidity and mortality. Guidelines for the management of postpartum haemorrhage (PPH) involve a stepwise escalation of pharmacological and eventual surgical approaches. The method of uterine tamponade using balloons has recently been added to the armamentarium for managing PPH. There are various balloons available including the Bakri, Foley, Sengstaken-Blakemore, Rusch and condom catheter. This paper reviews these uterine tamponade technologies in the management of PPH.
              Article 0 comments Cited 46 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): AJP Rep
                Journal ID (iso-abbrev): AJP Rep
                Journal ID (doi): 10.1055/s-00000169
                Title: AJP Reports
                Publisher: Thieme Medical Publishers (333 Seventh Avenue, New York, NY 10001, USA. )
                ISSN (Print): 2157-6998
                ISSN (Electronic): 2157-7005
                Publication date (Print): October 2019
                Publication date (Electronic): 05 December 2019
                Volume: 9
                Issue: 4
                Pages: e376-e383
                Affiliations
                [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
                [3 ]Harvard Medical School, Boston, Massachusetts
                [4 ]Harvard T. H. Chan School of Public Health, Boston, Massachusetts
                Author notes
                Address for correspondence Thomas F. Burke, MD, FACEP, FRSM Division of Global Health Innovation, Department of Emergency Medicine, Massachusetts General Hospital 125 Nashua Street, Suite 910, Boston, MA 02114 tfburke@ 123456mgh.harvard.edu
                Article
                Publisher ID: 190048
                DOI: 10.1055/s-0039-1697653
                PMC ID: 6894953
                SO-VID: ee4bb202-dd43-44b2-874e-b0fcddd46a84
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.

                History
                Date received : 17 May 2019
                Date accepted : 16 July 2019
                Categories
                Subject: Original Article

                Keywords: uncontrolled postpartum hemorrhage,uterine balloon tamponade,mechanical properties,medical device
                Data availability:
                Keywords: uncontrolled postpartum hemorrhage, uterine balloon tamponade, mechanical properties, medical device

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