A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation.

Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, in 2017, the mortality ratio was 462 out of every 100 000 live births, over 10 times higher than for high-resource settings. There are different treatments available for post-partum haemorrhage. The intrauterine balloon tamponade is a medical device that proved to be a simple and cost-effective approach. Currently, there are several balloon tamponades available, with different design and working principles. However, all these devices were designed for high-resource settings, presenting several aspects that could be inappropriate for many lower-income countries. This paper presents the results of a preclinical study aiming at informing the design, prototyping and validation of a 3D-printed intrauterine balloon tamponade concept, contributing towards the United Nation's Sustainable Development Goal 3: Good health and Well-being. Frugal engineering concepts and contextualised design techniques were applied throughout, to define the design requirements and specifications. The performance of the final prototype was validated against the requirements of the UK National Health System (NHS) technical guidelines and relevant literature, measuring the water leak and pressure drop over time, both open air and in a approximate uterus model. The resulting prototype is made up of six components, some of which are easy to retrieve, namely a water bottle, a silicone tube and an ordinary condom, while others can be manufactured locally using 3D printers, namely a modified bottle cap, a flow stopper and a valve for holding the condom in place. Validation testing bore promising results with no water or pressure leak open air, and minimal leaks in the approximate uterus model. This demonstrates that the 3D printed condom-based intrauterine balloon tamponade is performing well against the requirements and, when compared to the state of the art, it could be a more appropriate and more resilient solution to low-resource settings, as it bypasses the challenges in the supply of consumables and presents a greener option based on circular economy.

A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings.

The 3.1 target of the Sustainable Development Goals of the United Nations aims to reduce the global maternal mortality ratio to less than 70 maternal deaths per 100,000 live births by 2030. The last updates on this target show a significant stagnation in the data, thus reducing the chance of meeting it. What makes this negative result even more serious is that these maternal deaths could be avoided through prevention and the wider use of pharmacological strategies and devices to stop postpartum haemorrhage (PPH). PPH is the leading obstetric cause of maternal mortality in low- and middle-income countries (LMICs). Despite low-cost devices based on the uterine balloon tamponade (UBT) technique are already available, they are not safe enough to guarantee the complete stop of the bleeding. When effective, they are too expensive, especially for LMICs. To address this issue, this study presents the design, mechanical characterisation and technology assessment performed to validate a novel low-cost UBT kit, particularly a novel component, i.e., the connector, which guarantees the kit's effectiveness and represents the main novelty. Results proved the device's effectiveness in stopping PPH in a simulated scenario. Moreover, economic and manufacturing evaluations demonstrated its potential to be adopted in LMICs.

Short and long-term menstrual, reproductive, and mental health outcomes after the intrauterine use of chitosan tamponade or the Bakri balloon for severe postpartum hemorrhage: an observational study.

OBJECTIVE: This retrospective follow-up study analyzes the effect of intrauterine postpartum hemorrhage (PPH) therapy on menstrual, reproductive, and mental health outcomes. METHODS: All women who delivered at a university hospital between 2016 and 2021 with PPH and who needed intrauterine therapy were included. A questionnaire on well-being, menses, fertility, and reproductive outcomes was mailed to the patients. Those who did not reply were surveyed by telephone. RESULTS: A total of 214 women treated with chitosan-covered gauze (group A) and 46 women treated with a balloon tamponade (group B) were recruited, and their short-term courses were analyzed. For long-term follow-up, 71 women of group A (33%) and 21 women of group B (46%) could be reached. A total of 89% of group A and 95% of group B had regular menstrual bleeding in the most recent 12 months; 27% (group A) and 29% (group B) were trying to conceive again, and all of them did so successfully. There were 12 deliveries, 3 ongoing pregnancies, 3 miscarriages, and 2 terminations of pregnancies (TOP) in group A and 4 deliveries, 1 miscarriage, and 2 TOPs in group B. More than half of our study participants was sorted into grade II or III of the Impact of Events Scale, indicating they experienced clinical impacts in the form of psychological sequelae. One-quarter of patients had symptoms of post-traumatic stress disorder. CONCLUSION: Chitosan gauze as well as balloon tamponade appear to have few adverse effects on subsequent menstrual and reproductive function. Women after PPH are at increased risk of long-term adverse psychological outcomes.

Effect of Bakri balloon tamponade combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension undergoing cesarean delivery.

OBJECTIVE: To investigate the effect of Bakri balloon tamponade (BBT) combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension (PIH) undergoing cesarean delivery (CD). METHODS: This randomized, double-blind, controlled trial was conducted at The First Affiliated Hospital of Xingtai Medical College from October 2020 to June 2023. Patients with PIH who had persistent bleeding after CD and were unresponsive to uterine contractions, sutures, or uterine disconnection procedures were eligible participants. Eligible participants were randomly assigned to control and study groups, with 50 patients in each group. The control group used BBT combined with B-lynch uterine compression sutures, while the study group used BBT combined with modified Hayman suture. Intraoperative and postoperative bleeding and changes in vital signs were compared between the 2 groups. Moreover, changes in inflammation levels, coagulation function, and sex hormone levels were compared between the 2 groups before and after surgery. RESULTS: A total of 122 patients with persistent bleeding after CD were recruited, of whom 22 were excluded (16 cases of uterine contractions and/or local uterine myometrial sutures for hemostasis, 4 cases of preoperative uterine artery embolization, and 2 cases of uterine malformations). The intraoperative blood loss, postoperative blood loss at 2 hours, postoperative blood loss at 24 hours, and decrease in red blood cell and hemoglobin in the study group were significantly lower than those in the control group (P < .05). After surgery, the levels of inflammation, coagulation function, and sex hormone in both groups improved compared to before surgery, and the study group was significantly better than the control group (P < .05). In addition, the incidence of postoperative adverse events in the study group was significantly lower than that in the control group (P < .05). CONCLUSIONS: The hemostatic effect of BBT combined with B-lynch uterine compression sutures is comparable to that of BBT combined with modified Hayman suture for postpartum hemorrhage in pregnant women with PIH undergoing CD, but the latter has less blood loss, attenuated inflammatory response, reduced impact on coagulation function and ovarian function, and a lower incidence of adverse events.

Economic effects of treating postpartum hemorrhage with vacuum-induced hemorrhage control devices - A budget impact analysis of the Jada® System in the German obstetrics setting.

OBJECTIVE: This study aimed to assess the budget impact of vacuum-induced hemorrhage control (VHC) devices for treating postpartum hemorrhage (PPH) from the perspective of the German statutory health insurance (SHI). STUDY DESIGN: Evidence shows that treating PPH with VHC instead of uterine balloon tamponade (UBT) can reduce resource consumption (e.g., reduced number of blood transfusions and length of stay). A budget impact model combining aggregated German real-world reimbursement data of PPH cases with the assumption of resource reduction due to VHC usage was developed. Diagnosis-related groups (DRG) of PPH cases and their frequencies were collected using a publicly available database. A "downgrading mechanism" was performed, leading to a less resource-intensive DRG, i.e., resulting in a lower flat fee to be paid by SHI. Four subgroups were differentiated based on coded diagnoses and procedures: 1) PPH (O72.-) as main diagnosis, 2) PPH as secondary diagnosis, 3) UBT procedure coded, and 4) UBT or standard tamponade coded. Weighted averages of cost savings per case were calculated. RESULTS: Data from 7,129 (subgroup 1), 49,523 (subgroup 2), 1,668 (subgroup 3), and 3,406 (subgroup 4) cases were retrieved. After applying the downgrading mechanism, cost savings (weighted average) resulted in 184.09 €, 210.50 €, 921.33 €, and 633.74 € for subgroups 1-4, respectively, CONCLUSION: This is the first German budget impact analysis of VHC for the treatment of PPH. Results showed the highest cost-saving potential for cases currently treated with UBT. Demonstrating not only clinical but also financial consequences of innovative treatments is crucial for the adoption into clinical practice.

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.

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)

Uso exitoso del balón de Bakri en un caso de hemorragia postaborto de segundo trimestre y cesárea anterior / Successful use of Bakri balloon in a case of second trimester postabortion hemorrhage and prior caesarean section

Presentamos el caso de una secundigesta de 24 años (19+1 semanas de gestación) con cesárea anterior que presenta un aborto espontáneo y posterior hemorragia tras la evacuación uterina. Durante la exploración se constata una dehiscencia uterina. Ante el fracaso del tratamiento médico se coloca un balón de Bakri, consiguiendo detener el sangrado. Este caso pone de manifiesto la eficacia del taponamiento uterino en otras indicaciones diferentes a la hemorragia postparto. El manejo conservador con el balón de Bakri evitó una histerectomía, con la consiguiente preservación de la fertilidad y reducción de la morbi-mortalidad asociada

This article introduces the case of a 24-year-old gravida 2 (19+1 weeks of gestation) having had performed a previous cesarean, who presents a spontaneous abortion and a hemorrhage after uterine evacuation. Throughout the examination, it is remarkable a cesarean scar dehiscence and placenta accreta is suspected to be present. Having the starting therapies failed to work, a Bakri balloon is set managing to stop the bleeding. This case highlights the efficacy of uterine tamponade in situations different from postpartum hemorrhage. A hysterectomy was avoided with the Bakri balloon, resulting in the subsequent preservation of fertility and associated morbi-mortality reduction

El Balón de Bakri como herramienta en el manejo de la hemorragia post parto / THE BAKRI´S BALLOON AS AN IMPORTANT TOOL FOR THE MANAGEMENT OF POST PARTUM HEMORRHAGE

Introducción La hemorragia post parto es una de las complicaciones más graves del puerperio y una de las principales causas de mortalidad materna a nivel mundial. Dentro del esquema del manejo de la misma se encuentra el uso del balón de Bakri para evitar la histerectomía post parto. Objetivo: presentar la experiencia en la utilización del Balón de Bakri en un trabajo colaborativo entre los Servicios de Obstetricia del Hospital Nacional Posadas y de la Madre y el Niño de Formosa Capital entre enero de 2015 a junio de 2016. Método: Estudio transversal y descriptivo que incluyó a 25 pacientes con hemorragia post parto sin respuesta al tratamiento con Ocitócicos y que requirieron colocación del Balón de Bakri. Resultados: El balón de Bakri fue aplicado a 25 mujeres con hemorragia refractaria. La mediana de insuflación del Balón de Bakri fue de 300 (240/ 600 mL). La hemostasia se consiguió en 23 (92 %) de estas mujeres. Dos mujeres debieron ser histerectomizadas por continuar sangrando luego de la colocación del balón. Conclusión: El balón de Bakri es una herramienta eficaz para el manejo de la hemorragia post parto refractaria a carbetocina, evitando la histerectomía en el 92% de los casos.

Postpartum hemorrhage is one of the most serious complications of puerperium and one of the leading causes of maternal mortality worldwide. Within the framework of the management of it is the use of Bakri balloon to prevent puerperal hysterectomy. The aim of this study is to present the experience in the use of Bakri balloon in a collaborative work between the Obstetrics Departments of the Posadas National Hospital and the Madre y el Niño Hospital of Formosa Capital, Argentina, from January 2015 to June 2016. Methods: Cross-sectional descriptive study that included 25 patients with postpartum bleeding with uterine atony refractory to treatment with uterotonics and required Bakri balloon placement. Results: The Bakri ballon was applied to 25 women with refractory bleeding Oxytocics after vaginal delivery. The median Bakri balloon inflation was 300 (240/600 mL). Hemostasis was achieved in 23 (92%) of these women. Two women (8%) had to be undergone hysterectomy for bleeding continue after placement of the ball. Conclusion: The Bakri balloon is an effective tool for the management of post partum hemorrhage refractory to Carbetocin avoiding hysterectomy in 92% of cases.

Hemorragia obstétrica manejada con balón de Bakri / Obstetric hemorrhage management with the Bakri SOS balloon

Antecedentes: La Organización Mundial de la Salud reporta que existen en el mundo 536.000 muertes maternas al año, de las cuales 140.000 son originadas por hemorragia obstétrica, representando el 25% del total de dichas muertes. En México, se considera la segunda causa de muerte materna, con una tasa de mortalidad de 14,3 por 100.000 nacidos vivos. Objetivo: Conocer el porcentaje de éxitos de las pacientes con hemorragia obstétrica tratadas con balón de Bakri en el Instituto Nacional de Perinatología. Material y métodos: Se analizó una serie de casos, durante 2 años (2009-2011) en pacientes complicadas con hemorragia obstétrica, las cuales recibieron manejo conservador con balón de Bakri. Se encontró a 19 pacientes y se describieron los antecedentes obstétricos, personales, control prenatal, atención obstétrica, parámetros de laboratorios y desenlace perinatal. Resultados: El porcentaje de éxito con el balón de Bakri fue del 95% y solo el 5% se consideró fallido, ameritando histerectomía obstétrica. La pérdida hemática promedio fue 1.290 cc, con diferencia de 4 g/dl en los controles de hemoglobina pre- y posquirúrgicos. Dos días promedio de estancia en unidad de cuidados intensivos. El peso promedio de los recién nacidos fue 2.580 g y el 63% fue de sexo femenino. No se reportaron complicaciones por el uso del balón de Bakri. Se realizó una fórmula para estimar el llenado de balón en cc = 41 + (11 × semanas de gestación). Conclusión: El uso del balón de Bakri puede ser útil en el manejo conservador ante una hemorragia obstétrica con una tasa considerable de éxito y sin reportes de complicación debida al uso

Background: The World Health Organization reports that 536,000 maternal deaths occur per year, of which 140,000 are caused by obstetric hemorrhage, representing 25% of all maternal deaths. In Mexico, obstetric hemorrhage is the second cause of maternal death, with a mortality rate of 14.3/100,000 newborns. Objective: To describe the success rate in obstetric hemorrhage patients treated with the Bakri SOS balloon in the National Institute of Perinatology. Material and methods: From 2009- 2011, data were collected from obstetric hemorrhage patients (n = 19) who were treated conservatively with the Bakri SOS balloon in the Institute. Data on obstetric and personal history, prenatal care, obstetric care, laboratory values and perinatal outcomes were obtained. Results: The success rate with the Bakri SOS balloon was 95%, with a failure rate of only 5%; these patients required further hysterectomy. The mean blood loss was 1,290 cc, with a difference of 4 g of hemoglobin before and after surgery. The mean length of stay in the intensive care unit was 2 days. The mean birth weight was 2,580 g, and 63% of the neonates were females. There were no incidents or complications with the use of the Bakri SOS balloon. The formula to estimate balloon filling was cc = 41 + (11 × gestational age). Conclusion: The Bakri SOS balloon can be helpful to treat obstetric hemorrhage and has high success rates and no complications

Uso de balões intrauterinos em pacientes com hemorragia pós-parto / Use of intrauterine balloons in patients with postpartum haemorrhage

A hemorragia pós-parto é uma complicação presente em mais de 18% dos nascimentos e responsável por cerca de 25 a 30% das mortes maternas no mundo. No Brasil, apesar da ampliação do acesso aos serviços de saúde e da melhoria em praticamente todos os indicadores de saúde materna, esta etiologia continua se apresentando entre os três principais grupos de causas de morte no ciclo grávido-puerperal. Nas últimas décadas, várias técnicas conservadoras visando o controle hemorrágico no período pós-parto têm sido relatadas, com destaque para as técnicas de desvascularização uterina, suturas compressivas, embolização arterial, balões intrauterinos e a interrupção do ato operatório com laparostomia, empacotamento pélvico e posterior reabordagem cirúrgica. O presente artigo apresenta uma revisão do uso de balões intrauterinos no controle hemorrágico com destaque para os tipos, aplicabilidades e cronologia de invenção e publicações. Foram avaliados os balões de Sengstaken-Blakemore, os artesanais, as sondas de Foley, balão de Rusch, de Bakri e o BT-cath. Detalhou-se também o teste do tamponamento e a técnica do "sanduíche uterino".(AU)

Postpartum hemorrhage is present in over 18% of births and accounts for 25-30% of maternal deaths worldwide. In Brazil, despite the expansion of access to health care and the improvement of virtually all maternal health indicators, such etiology is still present among the three main causes of death during pregnancy and childbirth. In the last decades, several conservative techniques direct at controlling hemorrhage in the postpartum period have been reported, principally techniques of uterine devascularization, compression sutures, arterial embolization, intrauterine balloons and surgery interruption with laparostomy, pelvic packing and subsequent surgical intervention. This article presents a review of the use of intrauterine balloons in controlling hemorrhage especially types, applicability and chronology of invention and publications. Sengstaken-Blakemore balloons, the artisanal, Foley probes, Rusch balloon, Bakri and BT-cath were reviewed. The tamponade test and the "uterine sandwich" technique were also detailed.(AU)