Uterine Balloon Tamponade under Ultrasound Guidance in Women with Postpartum Hemorrhage: A Retrospective Cohort Study.

Background: Postpartum hemorrhage (PPH) represents one of the principal causes of maternal mortality and morbidity worldwide. Uterine balloon tamponade (UBT) is recommended for the treatment of postpartum hemorrhage due to uterine atony in women who do not respond to pharmacological first-line treatment. The success of UBT in bleeding control is related to the correct positioning of the device, since incorrect insertion can be associated with ineffectiveness and requires time-consuming repositioning maneuvers, with a further increase in blood loss. The use of ultrasound (US) during UBT may increase the success rate by preventing wrong positioning. This study aims to demonstrate the role of US guidance during UBT and to assess whether US guidance can ease positioning and reduce insertion times, preventing additional repositioning maneuvers, in comparison with a US check carried out after balloon insertion. Methods: This was a retrospective study including 370 women who underwent vaginal delivery, had PPH caused by uterine atony and required UBT at Sant'Anna Hospital from 2015 to 2019. The exclusion criteria were an abnormal placental site, vaginal or cervical trauma, coagulation defects, uterine anomalies, previous postpartum hemorrhage and previous caesarean section. Included subjects were divided into two groups: the US-guided group (n = 200) underwent Bakri balloon positioning under US guidance, and the non-guided group (n = 170) received a US check only after balloon insertion. The primary outcome was the success rate of the procedure, expressed as the percentage of cases with bleeding control without the need for balloon repositioning; the secondary outcomes were the length of the procedure and some parameters related to blood loss. Results: The success rate was 99% for the US-guided group vs. 86% for the non-guided group. None of the patients required hysterectomy. In the US-guided group with respect to the non-guided group, we observed a significant reduction in blood loss (1100 ± 450 vs. 1500 ± 600 mL; p < 0.001), Δhemoglobin level (1.8 ± 1.1 vs. 2.7 ± 2.0 g/dL, p < 0.001) and time required for the procedure (8 vs. 13 min, p < 0.001). Conclusions: Our data suggest that the use of US guidance for placement of UBT was associated with reduced need for balloon repositioning, lower blood loss, and faster resolution of postpartum hemorrhage.

Improving maternal safety: Usability and performance assessment of a new medical device for the treatment of postpartum haemorrhage.

Postpartum haemorrhage (PPH) is an obstetric emergency causing nearly one-quarter of maternal deaths worldwide, 99% of these in low-resource settings (LRSs). Uterine balloon tamponade (UBT) devices are a non-surgical treatment to stop PPH. In LRSs, low-cost versions of UBT devices are based on the condom balloon tamponade (CBT) technique, but their effectiveness is limited. This paper discusses the experimental study to assess the usability and performance of a medical device, BAMBI, designed as an alternative to current CBT devices. The testing phase involved medical and non-medical personnel and was focused on testing BAMBI's usability and effectiveness compared to a standard CBT solution. We collected measures of the execution time and the procedure outcome. Different training procedures were also compared. Results show a significant preference for the BAMBI device. Besides, medical and non-medical subjects reached comparable outcomes. This aspect is highly relevant in LRSs where the availability of medical personnel could be limited.

Intrauterine devices in the management of postpartum hemorrhage.

Obstetrical hemorrhage is a relatively frequent obstetrical complication and a common cause of maternal morbidity and mortality worldwide. The majority of maternal deaths attributable to hemorrhage are preventable, thus, developing rapid and effective means of treating postpartum hemorrhage is of critical public health importance. Intrauterine devices are one option for managing refractory hemorrhage, with rapid expansion of available devices in recent years. Intrauterine packing was historically used for this purpose, with historical cohorts documenting high rates of success. Modern packing materials, including chitosan-covered gauze, have recently been explored with success rates comparable to uterine balloon tamponade in small trials. There are a variety of balloon tamponade devices, both commercial and improvised, available for use. Efficacy of 85.9% was cited in a recent meta-analysis in resolution of hemorrhage with the use of uterine balloon devices, with greatest success in the setting of atony. However, recent randomized trials have demonstrated potential harm associated with improvised balloon tamponade use In low resource settings and the World Health Organization recommends use be restricted to settings where monitoring is available and care escalation is possible. Recently, intrauterine vacuum devices have been introduced, which offer a new mechanism for achieving hemorrhage control by mechanically restoring uterine tone via vacuum suction. The Jada device, which is is FDA-cleared and commercially available in the US, found successful bleeding control in 94% of cases in an initial single-arm trial, with recent post marketing registry study described treatment success following hemorrhage in 95.8% of vaginal and 88.2% of cesarean births. Successful use of improvised vacuum devices has been described in several studies, including suction tube uterine tamponade via Levin tubing, and use of a modified Bakri balloon. Further research is needed with head-to-head comparisons of efficacy of devices and assessment of cost within the context of both device pricing and overall healthcare resource utilization.

Especificidades técnicas no tamponamento uterino com balões e algumas dificuldades técnicas / Technical specificities in uterine tamponade with balloons and some technical difficulties

A mortalidade materna é inaceitavelmente alta. A hemorragia pós-parto encontra- se na primeira posição no mundo, tendo como principal causa específica a atonia uterina. Eventualmente, as medidas iniciais e a terapia farmacológica não são efetivas no controle do sangramento, impondo a necessidade de tratamentos invasivos, cirúrgicos ou não. Entre esses, o tamponamento uterino com balão requer recursos locais mínimos e não exige treinamento extensivo ou equipamento muito complexo. Entretanto, algumas dificuldades podem ocorrer durante a inserção, infusão ou manutenção do balão na cavidade uterina, com especificidades relacionadas à via de parto. Após o parto vaginal, a dificuldade mais prevalente é o prolapso vaginal do balão. Na cesárea, as principais dificuldades são a inserção e o posicionamento do balão na cavidade uterina, principalmente nas cesáreas eletivas. Este artigo revisa e ilustra as principais dificuldades e especificidades relacionadas ao tamponamento uterino com balões.

Maternal mortality is unacceptably high. Postpartum hemorrhage is ranked first in the world, with the main specific cause being uterine atony. Eventually, initial measures and pharmacological therapy are not effective in controlling bleeding, imposing the need for invasive treatments, surgical or not. Among these, uterine balloon tamponade requires minimal local resources and does not require extensive training or very complex equipment. However, some difficulties may occur during insertion, infusion, or maintenance of the balloon in the uterine cavity, with specificities related to the mode of delivery. After vaginal delivery, the most prevalent difficulty is vaginal balloon prolapse. In cesarean section, the main difficulty is the insertion and positioning of the balloon in the uterine cavity, especially in elective cesarean sections. This article reviews and illustrates the main difficulties and specificities related to uterine balloon tamponade.

Uterine tamponade in postpartum hemorrhage with handmade balloons: Comparison of manufacturing, infusion, and total times.

OBJECTIVE: To compare the manufacturing, infusion, and total times of handmade balloons for uterine tamponade using the El Hennawy and Alves techniques, given the failure of initial measures and uterotonic therapy to control postpartum hemorrhage. METHODS: An open clinical trial (clinical article) was conducted among 30 physicians, residents, and assistants in an Obstetrics Department. Each participant manufactured and infused one of two different balloons compared in the study, in a randomly predefined sequence. The manufacturing and infusion times were timed by the researchers and their medians were compared using the t test or Mann-Whitney U test. RESULTS: The manufacturing time of the El Hennawy balloon was 72 s lower in relation to the Alves balloon (P < 0.010). Regarding the infusion time, the Alves balloon was filled faster than the El Hennawy balloon (P < 0.010). The total time (manufacturing and infusion) of Alves balloon was also lower than the El Hennawy device (P < 0.010). CONCLUSIONS: Although the El Hennawy balloon was manufactured more quickly, the total time of manufacturing and infusing the Alves balloon was much faster, which makes it the most suitable device to be used in critical situations of postpartum hemorrhage.

Balões de tamponamento intrauterino na hemorragia pós-parto ­ Atualizações / Uterine balloon tamponade in postpartum hemorrhage ­ Updates

A hemorragia pós-parto continua sendo uma condição relacionada a elevada morbimortalidade materna, sendo essenciais o diagnóstico precoce e o início do tratamento farmacológico. Em caso de falha, os balões de tamponamento uterino são uma alternativa eficiente, com aplicabilidade crescente na prática clínica. Esses dispositivos são seguros, apresentam baixa incidência de eventos adversos e reduzem as taxas de procedimentos cirúrgicos. Existe uma ampla variedade de modelos, tanto industriais quanto artesanais, com acúmulo de relatos na literatura demonstrando sua eficácia. Este artigo descreve os principais balões intrauterinos, com ênfase nos modelos mais novos, aplicabilidade, taxas de sucesso e eventos adversos.(AU)

Postpartum hemorrhage continues to be a condition related to high maternal morbimortality, early diagnosis and initiation of pharmacological treatment are essential. In case of failure, uterine balloon tamponade is an efficient alternative, with increasing applicability in clinical practice. These devices are safe, have a low incidence of adverse events and reduce the overall rates of surgical procedures. There is a wide variety of models, both industrial and artisanal, with an accumulation of reports in the literature demonstrating their effectiveness. This article describes the main intrauterine balloons, with an emphasis on newer models, applicability, success rates and adverse events.(AU)

Impact of efforts to prevent maternal deaths due to obstetric hemorrhage on trends in epidemiology and management of severe postpartum hemorrhage in Japan: a nationwide retrospective study.

BACKGROUND: The Japan Society of Obstetrics and Gynecology and the Japan Association of Obstetricians and Gynecologists have issued the guidelines and recommendations on postpartum hemorrhage since 2010 and have been conducted widespread educational activities from 2012. The aim of this study was to investigate the impact of these efforts by the Societies to prevent maternal deaths due to obstetric hemorrhage on trends in epidemiology and management of severe postpartum hemorrhage in Japan. METHODS: A national retrospective cohort study was conducted using the national database of health insurance claims for the period 2012 and 2018. The subjects were all insured women who received a blood transfusion for postpartum hemorrhage. The primary endpoints of this study were hysterectomy and maternal mortality. The etiology of hemorrhage, treatment facility, type of procedure, and blood transfusion volume were tabulated. RESULTS: Women with postpartum hemorrhage that underwent transfusion increased from 3.5 to 5.5 per 1000 deliveries between 2012 and 2018. The most common cause of postpartum hemorrhage was atonic hemorrhage. After insurance coverage in 2013, the intrauterine balloon tamponade use increased to 20.3% of postpartum hemorrhages treated with transfusion in 2018, while the proportion of hysterectomy was decreased from 7.6% (2013-2015) to 6.4% (2016-2018) (p < 0.0001). The proportion of postpartum hemorrhage in maternal deaths decreased from 21.1% (2013-2015) to 14.1% (2016-2018) per all maternal deaths cases (p = 0.14). Cases with postpartum hemorrhage managed in large referral hospitals was increased (65.9% in 2012 to 70.4% in 2018) during the study period (p < 0.0001). CONCLUSIONS: The efforts by the Societies to prevent maternal mortality due to obstetric hemorrhage resulted in a significant decrease in the frequency of hysterectomies and a downward trend in maternal mortality due to obstetric hemorrhage.

Every Second Matters - uterine balloon tamponade implementation across ten medical colleges in Maharashtra and Madhya Pradesh in India: A qualitative study.

OBJECTIVE: To understand facilitators, barriers, and perceptions of the Every Second Matters uterine balloon tamponade (ESM-UBT) package implemented across 10 medical colleges in India, 3 years after the program was introduced. METHODS: Semi-structured interviews were conducted until thematic saturation in March 2020. Multiple provider cadres, including nurses, Obstetrics/Gynecology residents, professors, and program leads, were eligible. Interviews were transcribed and thematically coded using an inductive method. RESULTS: Sixty-two obstetric providers were interviewed. Facilitators of implementation included recurrent training, improved teamwork and communication, strong program leadership, and involvement of lower-level facilities. Barriers to implementation included administrative hurdles, high staff turnover, language barriers, and resources required to reach and train lower-level facilities. Overall, the majority of clinicians viewed the ESM-UBT package as a useful intervention in aiding efforts to reduce maternal deaths from postpartum hemorrhage. CONCLUSIONS: Among 10 medical colleges in India the ESM-UBT package is seen as a beneficial intervention for managing refractory atonic postpartum hemorrhage, and for reducing maternal morbidity and mortality. Identified facilitators of and barriers to implementation of the ESM-UBT package in India should be used to guide future implementation efforts.

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.

OBJECTIVE: To evaluate the impact of introducing a uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemorrhage (PPH), mainly due to uterine atony, in health facilities in India on the rates of PPH-related maternal death and invasive procedures for PPH control. METHODS: We used a quasi-experimental, difference-in-difference (DID) design to compare changes in the rates of a composite outcome (PPH-related maternal death and/or artery ligation, uterine compression sutures, or hysterectomy) among women delivering in nine intervention facilities compared with those delivering in two control facilities, before and after the introduction of ESM-UBT. RESULTS: The study sample included 214 123 deliveries (n = 78 509 before ESM-UBT introduction; n = 47 211 during ESM-UBT introduction; and n = 88 403 after ESM-UBT introduction). After introduction of ESM-UBT, there was a significant decline in the rate of the primary composite outcome in intervention facilities (21.0-11.4 per 10 000 deliveries; difference -9.6, 95% confidence interval -14.0 to -5.4). Change in the rate of the primary composite outcome was not significant in control facilities (11.7-17.2 per 10 000 deliveries; difference 5.4, 95% confidence interval -3.9 to 14.9). DID analyses showed there was a significant reduction in the rate of the primary composite outcome in intervention facilities relative to control facilities (adjusted DID estimate -15.0 per 10 000 points, 95% confidence interval -23.3 to -6.8; P = 0.005). CONCLUSION: Introduction of the ESM-UBT in health facilities in India was associated with a significant reduction in PPH-related maternal death and/or invasive procedures for PPH control.

"Suction Tube Uterine Tamponade" for treatment of refractory postpartum hemorrhage: Internal feasibility and acceptability pilot of a randomized clinical trial.

OBJECTIVE: To assess feasibility and acceptability of a novel, low-cost "Suction Tube Uterine Tamponade" (STUT) treatment for refractory postpartum hemorrhage (PPH). METHODS: We allocated patients with refractory PPH by randomly ordered envelopes to STUT or routine uterine balloon tamponade (UBT, Ellavi free-flow system) in 10 hospitals in South Africa. In the STUT group, a 24FG Levin stomach tube was inserted into the uterine cavity and vacuum created with a vacuum pump or manual vacuum aspiration syringe. RESULTS: For this internal pilot study, 12 participants were allocated to STUT and 12 to UBT. Insertion failed in one of each group and was recorded as difficult in 3/10 STUT and 4/9 UBT insertions respectively (five missing data). There were two laparotomies and one intensive care unit admission in the UBT group. Pain during STUT insertion was graded as none/mild in 9/10 and severe in 1/10. The experience of the STUT procedure was graded as fine in 4/11 and "uncomfortable but acceptable" in 7/11. CONCLUSION: STUT is feasible and acceptable, justifying continuation of our trial. These data will also inform a large World Health Organization trial to test effectiveness of uterine tamponade methods. The numbers are too small to support any clinical recommendation.

Intrauterine balloon tamponade for postpartum hemorrhage / Tamponamento por balão intrauterino no tratamento da hemorragia pós-parto

Abstract Introduction: Postpartum hemorrhage is an obstetric emergency with high prevalence and significant morbidity and mortality, especially in areas with reduced access to specialized health services. Objective: To evaluate the effectiveness of intrauterine balloon tamponade in controlling postpartum hemorrhage, with the aim to reduce the need for emergency surgical interventions and decrease maternal mortality. Methods: A systematic review of randomized clinical trials, guided by the Cochrane Handbook for Systematic Reviews of Interventions and reported through the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomized clinical trials that evaluated the use of different types of balloons for intrauterine tamponade as a strategy for reducing or stopping postpartum hemorrhage compared to other interventions (pharmacological or surgical) were considered for inclusion. Results: Four studies evaluated 498 patients. In 80% of the reported cases, hemorrhage cessation was observed within a mean interval of 15 min after device insertion. The device permanence time was 24 h. No serious adverse events were reported. Due to clinical heterogeneity between studies, it was not possible to perform a quantitative synthesis. Conclusion: We did not find enough evidence to support the routine use of uterine tamponade devices as a protocol practice in the control of refractory postpartum hemorrhage. However, the use of these devices seems to be promising in cases where first line interventions fail and may play an important role in decreasing maternal morbidity and mortality and in uterine preservation.

Resumo Introdução: A hemorragia pós-parto trata-se de uma emergência obstétrica com elevada prevalência e morbimortalidade significativa, sobretudo em contextos de baixa acessibilidade a serviços especializados de saúde. Objetivo: Avaliar a efetividade do tamponamento por balão intrauterino no controle da hemorragia pós-parto, redução da necessidade de intervenções cirúrgicas de emergência e redução da mortalidade materna. Métodos: Revisão sistemática de ensaios clínicos randomizados, orientada pelo Cochrane Handbook for Systematic Reviews of Interventions e relatada através do Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Foram considerados como critérios de elegibilidade ensaios clínicos randomizados que avaliaram o uso de diferentes tipos de balão para tamponamento intrauterino enquanto estratégia para a redução ou cessação da hemorragia pós-parto quando comparados a outras intervenções (farmacológicas ou cirúrgicas). Resultados: Quatro estudos avaliaram 498 pacientes para os desfechos preconizados. Em 80% dos casos relatados observou-se a cessação da hemorragia em um intervalo médio de 15 minutos, após a inserção dos dispositivos. O tempo de permanência dos dispositivos foi de 24 horas. Não foram relatados eventos adversos graves. Devido à heterogeneidade clínica entre os estudos, não foi possível realizar síntese quantitativa. Conclusão: Os achados obtidos não fornecem evidências suficientes para sustentar a utilização rotineira dos dispositivos de tamponamento uterino enquanto prática protocolar no controle da hemorragia pós-parto refratária. A utilização destes dispositivos, no entanto, parece ser promissora diante da falha das intervenções de primeira linha, podendo desempenhar um importante papel em termos de redução de morbimortalidade materna e preservação uterina.

Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.

OBJECTIVES: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. SEARCH STRATEGY: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. STUDY SELECTION: Randomised and non-randomised comparative studies. OUTCOMES: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. RESULTS: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. CONCLUSIONS: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. TWEETABLE ABSTRACT: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.

Efficacy of Intra-Uterine Tamponade Balloon in Post-Partum Hemorrhage after Cesarean Delivery: An Impact Study.

Invasive therapies (surgery or radiological embolization) are used to control severe post-partum hemorrhage. The intra-uterine tamponade balloon is a potential alternative, well documented after vaginal delivery. However, available data on its use after cesarean delivery remain scarce. This study assessed the efficacy of the intra-uterine tamponade balloon during post-partum hemorrhage in a cesarean delivery setting. Using a retrospective impact design, post-partum hemorrhage-related outcomes before ("pre-balloon" period) versus after implementation of intra-uterine tamponade balloon ("post-balloon" period) were compared. All women with post-partum hemorrhage requiring potent uterotonic treatment with prostaglandins after cesarean delivery over a 9-year period were eligible. The primary outcome was the rate of invasive procedure (conservative surgery, radiological embolization and/or hysterectomy). p < 0.05 was considered statistically significant. A total of 279 patients were included (140 vs. 139). Most baseline characteristics were comparable between the two studied periods. The success rate of the intra-uterine tamponade balloon was 82%, and no related complications occurred. Rates of invasive procedures and transfusion were significantly reduced (28.6% vs. 11.5%, p < 0.001 and 44.3% vs. 28.1%, p = 0.006 respectively) during the "post-balloon" period, and length of hospital stay was shorter (p < 0.001). Implementation of intra-uterine tamponade balloon during post-partum hemorrhage after cesarean delivery appears to be safe and effective, with a decrease in both invasive procedures and transfusion rates.

Cost-effectiveness of uterine tamponade devices for the treatment of postpartum hemorrhage: A systematic review.

BACKGROUND: Uterine tamponade is widely promoted for treating refractory postpartum hemorrhage (PPH); however, its cost-effectiveness may vary depending on unit costs and setting. OBJECTIVE: To review available data on cost-effectiveness of uterine tamponade devices when used for PPH treatment. SEARCH STRATEGY: PubMed and EMBASE were searched (1980 to January 2020), as well as the National Health Services Economic Evaluation database from inception (1995) to March 2015. SELECTION CRITERIA: Eligible studies were any type of economic evaluation, or effectiveness studies that provided cost or economic data. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened studies, extracted data, and assessed quality. MAIN RESULTS: Eleven studies using a range of devices (condom catheter, uterine suction devices, Bakri, Inpress, Ellavi) were identified. Cost of condom catheter devices or kits ranged from US$0.64 to US$6, whereas purpose-designed device costs were up to US$400. Two studies that took a health system perspective assessed the cost-effectiveness of using uterine balloon tamponade and suggested that it was highly cost-effective because of the low cost per disability-adjusted life-year averted, although both used effect estimates from case series. CONCLUSIONS: Evidence on the cost-effectiveness of uterine tamponade devices was limited and not generalizable. Rigorous economic evaluations based on updated effect estimates are needed.

A condom uterine balloon device among referral facilities in Dar Es Salaam: an assessment of perceptions, barriers and facilitators one year after implementation.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death in Tanzania. The Every Second Matters for Mothers and Babies- Uterine Balloon Tamponade (ESM-UBT) device was developed to address this problem in women with atonic uterus. The objective of this study was to understand the barriers and facilitators to optimal use of the device, in Dar es Salaam Tanzania 1 year after implementation. METHODS: Semi-structured interviews of skilled-birth attendants were conducted between May and July 2017. Interviews were recorded, coded and analyzed for emergent themes. RESULTS: Among the participants, overall there was a positive perception of the ESM-UBT device. More than half of participants reported the device was readily available and more than 1/3 described ease and success with initial use. Barriers included fear and lack of refresher training. Finally, participants expressed a need for training and device availability at peripheral hospitals. CONCLUSION: The implementation and progression to optimal use of the ESM-UBT device in Tanzania is quite complex. Ease of use and the prospect of saving a life/preserving fertility strongly promoted use while fear and lack of high-level buy-in hindered utilization of the device. A thorough understanding and investigation of these facilitators and barriers are required to increase uptake of the ESM-UBT device.

Assessment of extravasation on ruptured uterine artery pseudoaneurysm using contrast-enhanced ultrasonography during uterine balloon tamponade.

OBJECTIVE: Contrast-enhanced ultrasonography (CEU) has been used in critical trauma situations to visualize extravasation; however, its use is limited in the field of obstetrics. Cases of ruptured uterine artery pseudoaneurysm (UAP) were analyzed to clarify the efficacy to CEU during uterine balloon tamponade. METHODS: Cases of ruptured UAP diagnosed at a teaching university hospital from January 2015 to December 2017 were retrospectively analyzed. UAP was diagnosed using color Doppler ultrasonography. Extravasation was identified using computed tomography and double checked using CEU with an intravenously administered contrast agent (Sonazoid; Daiichi Sankyo Company, Ltd., Tokyo, Japan) and an ultrasound instrument (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan). A balloon was then inserted into the uterine cavity and inflated at the point of bleeding until extravasation ceased. RESULTS: Three patients exhibited ruptured UAP during the study period. Bleeding points were successfully identified using CEU in all cases, and hemostasis was achieved using uterine balloon tamponade. Obliteration of UAP was confirmed using magnetic resonance imaging, and no patients developed recurrent UAP or any complications. CONCLUSION: CEU can be used at the bedside to promptly diagnose ruptured UAP. Moreover, it precisely facilitates balloon compression at the point of bleeding.

The association between intrauterine balloon tamponade volume and postpartum hemorrhage outcomes.

OBJECTIVE: To determine the effect of intrauterine balloon tamponade (IUBT) on the outcomes of postpartum hemorrhage (PPH) according to the balloon volume and to investigate the clinical factors associated with poor PPH outcomes. METHODS: A retrospective cohort study was conducted in which patients with PPH underwent IUBT from January 2016 to August 2018. Patients with an IUBT volume greater than 350 mL (n=76) were compared to patients with an IUBT volume less than 350 mL (n=213). The clinical outcomes related to PPH included blood transfusion, estimated blood loss (EBL) after balloon placement, uterine artery embolization (UAE) after IUBT, and postpartum hospitalization. The results were analyzed by multivariate logistic regression models. RESULTS: None of the clinical outcomes related to PPH and evaluated in our study were favorable in patients with an IUBT volume greater than 350 mL. Other factors associated with poor PPH outcomes after IUBT were placental site hemorrhage, shock index (SI) before IUBT, and antenatal hemoglobin. CONCLUSION: It is better to avoid unnecessary balloon inflation in IUBT if the bleeding is reduced, and more attention should be paid to the procedure when the balloon is large (≥350 mL) than when it is small (<350 mL).

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

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.

Scaling up interventions: findings and lessons learned from an external evaluation of Niger's National Initiative to reduce postpartum hemorrhage.

BACKGROUND: Niger has one of the highest maternal mortality ratios in Sub Saharan Africa, of which postpartum hemorrhage is the leading cause. In 2014, Health and Development International and the Ministry of Health of Niger launched an initiative to introduce and scale-up three PPH interventions in health facilities nationwide: misoprostol, uterine balloon tamponade, and the non-pneumatic anti-shock garment. METHODS: A two-phase mixed-methods evaluation was conducted to assess implementation of the initiative. Health facility assessments, provider interviews, and household surveys were conducted in May 2016 and November 2017. RESULTS: All evaluation facilities received misoprostol prevention doses. However, shortages in misoprostol treatment doses, UBT kits, and NASG stock were documented. Health provider training increased while knowledge of each PPH intervention varied. Near-universal uterotonic coverage for PPH prevention and treatment was achieved and sustained throughout the evaluation period. Use of UBT and NASG to manage PPH was rare and differed by health facility type. Among community deliveries, fewer than 22% of women received misoprostol at antenatal care for self-administered prophylaxis. Among those who did, almost all reported taking the drugs for PPH prevention in each phase. CONCLUSIONS: This study is the first external evaluation of a comprehensive PPH program taking misoprostol, UBT, and NASG to national scale in a low resource setting. Although gaps in service delivery were identified, results demonstrate the complexities of training, managing stock, and implementing system-wide interventions to reach women in varying contexts. The experience provides important lessons for other countries as they develop and expand evidence-based programs for PPH care.