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.

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.

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.

Uterine packing with chitosan-covered tamponade to treat postpartum hemorrhage.

Postpartum hemorrhage remains a major cause of maternal mortality and morbidity worldwide with higher rates found in resource-challenged countries. Conventional use of uterotonics such as oxytocin, prostaglandins, and medications to support coagulation, such as fibrinogen and tranexamic acid, are helpful but may not be sufficient to arrest life-threatening postpartum hemorrhage. Severe postpartum hemorrhage leads to an increased need for blood transfusions and the use of invasive techniques, such as intrauterine balloon tamponade, compression sutures, and arterial ligation, as advanced steps in the management cascade. In extreme cases where hemorrhage is resistant to these therapies, a hysterectomy may be necessary to avoid possible maternal death. Uterine packing with a chitosan-covered tamponade is an emerging tool in the armamentarium of the obstetrical team, especially when resources for advance surgical and other invasive options may be limited. Modified chitosan-impregnated gauze was originally described in the management of acute hemorrhage in the field of military medicine, combining the physiological antihemorrhaging effect of modified chitosan with a compression tamponade for the acute treatment of wound bleeding. The first described use in obstetrics was in 2012, showing that the chitosan-covered tamponade is an effective intervention to arrest ongoing therapy-resistant postpartum hemorrhage. Further studies showed a reduction in hysterectomies and blood transfusions. The method is, however, underreported and is not yet an established method used worldwide. To demonstrate the step-by-step application of the intrauterine chitosan-covered tamponade in the management of therapy-resistant postpartum hemorrhage, we have produced a teaching video to illustrate the important steps and techniques to optimize the effectiveness and safety of this novel intervention.

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.

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.

Intra-uterine packing: an effective and affordable tool in the management of post-partum hemorrhage - cohort study.

Introduction: postpartum hemorrhage is the main cause of maternal death worldwide. Uterine balloon packing has shown promising outcomes in PPH management. Nevertheless, its usage is limited in low- and middle-income countries due to associated costs. Uterine packing using gauzes presents a potentially efficient and cost-effective alternative. This study aims to assess the safety and efficacy of intra-uterine packing with gauzes in managing postpartum hemorrhage. Methods: this was a retrospective study over a period of two years and six months. All patients who experienced PPH due to uterine atony during vaginal delivery, with no response to medical first-line treatment, were included. IUP using gauze was employed as a second-line intervention. The primary outcome was the success of postpartum hemorrhage management. Secondary outcomes included patient vitals, the need for blood transfusion, change in hemoglobin levels (delta Hemoglobin), and maternal morbidity (post-partum infection, Sheehan syndrome, and retained gauzes). Results: the study included 63 patients. The mean age was 30.06 ± 5.6, the mean gravida was 2.65 ± 1.9 and the mean para was 2.12 ± 1.31. None of these patients experienced major complications following gauze insertion. Three patients underwent laparotomy and conservative surgical management was performed. Hysterectomy was not required for any participant, and no maternal deaths were recorded.

Intrauterine Postpartum Hemorrhage-Control Devices.

Postpartum hemorrhage , defined as a cumulative blood loss of 1,000 mL or more or blood loss associated with signs or symptoms of hypovolemia regardless of the route of delivery, is the leading cause of preventable maternal death worldwide. The United States has one of the highest maternal mortality rates among developed countries, with about 14% of all maternal deaths associated with postpartum hemorrhage. Although postpartum hemorrhage has multiple causes, the most common is uterine atony-when the uterus fails to adequately contract after childbirth-accounting for 80% of all postpartum hemorrhages. When postpartum hemorrhage occurs despite preventive measures, therapeutic measures are used. Intrauterine hemorrhage-control devices are often the second-line therapy when medical management is unsuccessful. Despite its widespread use in current obstetric practice, the mechanism of intrauterine balloon tamponade, such as the Bakri balloon, is counterintuitive to the physiologic uterine contraction that occurs after delivery to control bleeding, and data on its effectiveness are mixed. Vacuum-induced hemorrhage control, such as with the Jada System, cleared by the U.S. Food and Drug Administration in 2020, is a novel modality for control of postpartum bleeding. It mimics postpartum physiology by applying low-level intrauterine negative pressure to facilitate uterine compressive forces, thereby constricting blood vessels to achieve hemostasis. Preliminary data from four studies are promising but are limited by a lack of control groups, selection bias, or modest sample sizes. The results of ongoing and planned randomized controlled trials will clarify the role of the Jada System for reducing morbidity from postpartum hemorrhage.

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.

Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial.

BACKGROUND: Many questions remain about the appropriate use of intrauterine balloon devices in postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. Available data suggest that early use of intrauterine balloon tamponade might be beneficial. OBJECTIVE: This study aimed to compare the effect of intrauterine balloon tamponade used in combination with second-line uterotonics vs intrauterine balloon tamponade used after the failure of second-line uterotonic treatment on the rate of severe postpartum hemorrhage in women with postpartum hemorrhage after vaginal delivery refractory to first-line uterotonics. STUDY DESIGN: This multicenter, randomized, controlled, parallel-group, nonblinded trial was conducted at 18 hospitals and enrolled 403 women who had just given birth vaginally at 35 to 42 weeks of gestation. The inclusion criteria were a postpartum hemorrhage refractory to first-line uterotonics (oxytocin) and requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin). In the study group, the sulprostone infusion was combined with intrauterine tamponade by an ebb balloon performed within 15 minutes of randomization. In the control group, the sulprostone infusion was started alone within 15 minutes of randomization, and if bleeding persisted 30 minutes after the start of sulprostone infusion, intrauterine tamponade using the ebb balloon was performed. In both groups, if the bleeding persisted 30 minutes after the insertion of the balloon, an emergency radiological or surgical invasive procedure was performed. The primary outcome was the proportion of women who either received ≥3 units of packed red blood cells or had a calculated peripartum blood loss of >1000 mL. The prespecified secondary outcomes were the proportions of women who had a calculated blood loss of ≥1500 mL, any transfusion, an invasive procedure and women who were transferred to the intensive care unit. The analysis of the primary outcome with the triangular test was performed sequentially throughout the trial period. RESULTS: At the eighth interim analysis, the independent data monitoring committee concluded that the incidence of the primary outcome did not differ between the 2 groups and stopped inclusions. After 11 women were excluded because they met an exclusion criterion or withdrew their consent, 199 and 193 women remained in the study and control groups, respectively, for the intention-to-treat analysis. The women's baseline characteristics were similar in both groups. Peripartum hematocrit level change, which was needed for the calculation of the primary outcome, was missing for 4 women in the study group and 2 women in the control group. The primary outcome occurred in 131 of 195 women (67.2%) in the study group and 142 of 191 women (74.3%) in the control group (risk ratio, 0.90; 95% confidence interval, 0.79-1.03). The groups did not differ substantially for rates of calculated peripartum blood loss pf ≥1500 mL, any transfusion, invasive procedure, and admission to an intensive care unit. Endometritis occurred in 5 women (2.7%) in the study group and none in the control group (P=.06). CONCLUSION: The early use of intrauterine balloon tamponade did not reduce the incidence of severe postpartum hemorrhage compared with its use after the failure of second-line uterotonic treatment and before recourse to invasive procedures.

A comparison of special intrauterine balloons and intrauterine contraceptive devices in the treatment of intrauterine adhesions.

PURPOSE: This study aimed to compare the efficacy of a special kind of intrauterine balloon (IUB) and that of an intrauterine contraception device (IUD) for patients with intrauterine adhesions (IUAs) after transcervical resection of adhesion (TCRA). METHODS: In this retrospective cohort study, after TCRA, 31 patients received a special IUB, and 38 patients received an IUD. The Fisher exact test, logistic regression method, Kaplan-Meier method and Cox proportional hazards regression model were used for statistical analysis. A two-sided value of P < 0.05 was considered statistically significant. RESULTS: The readhesion rate significantly differed between the IUB group and IUD group, at 15.39% and 54.06%, respectively (P = 0.002). For recurrent moderate IUA, patients in the IUB group had lower scores than patients in the IUD group (P = 0.035). There was a significant difference in the intrauterine pregnancy rate of IUA patients in the IUB group and IUD group after treatment, with rates of 55.56% and 14.29%, respectively (P = 0.015). CONCLUSION: Patients in the special IUB group had better outcomes than those in the IUD group, which has a certain guiding significance for clinical work.

Vacuum-Induced Hemorrhage Control versus Uterine Balloon Tamponade for Postpartum Hemorrhage.

OBJECTIVE: To compare maternal outcomes of uterine balloon tamponade (UBT) versus an intrauterine vacuum-induced hemorrhage control device (VHD) for the management of primary postpartum hemorrhage (PPH). METHODS: Retrospective cohort of all patients with PPH due to uterine atony treated with an intrauterine device within a university health system from January 2019 to June 2021. The primary outcome of massive transfusion, defined as PPH requiring transfusion of ≥4 units of packed red blood cells (PRBC), was compared between 2 groups: UBT (n = 78) versus VHD (n = 36). Statistical analysis included the use of chi-squared and Wilcoxon rank sum tests with statistical significance set at P < 0.05. RESULTS: Baseline characteristics were similar between the 2 groups. The proportion of patients who received ≥4 units of PRBC was significantly lower in the VHD group compared to the UBT group (2.8% vs. 20.5%, P = <0.01). The proportion of patients who were transfused ≥2 units of PRBC and median estimated blood loss (EBL) were also both significantly lower in the VHD group compared to the UBT group (36.1% vs. 57.7%, P = < 0.01, and 1 500 mL vs. 1 875 mL, P = 0.02, respectively). Rates of other secondary outcomes were similar between the 2 groups. CONCLUSION: Our data suggest that the use of intrauterine VHD in the management of PPH is associated with a lower number of massive transfusions and EBL compared to UBT. Randomized controlled trials are needed before drawing definitive conclusions on which device is more effective in this setting.

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.

The role of ultrasound in the diagnosis and management of postpartum hemorrhage.

Postpartum hemorrhage (PPH) is the leading cause of death or severe morbidity for the mother after delivery. As a consequence healthcare staff working in the delivery room should be trained to perform a prompt diagnosis and adequate management of PPH. Uneventful outcome is induced correct identification of the underlying cause of hemorrhage. Ultrasound is a promising technique for the prompt diagnosis of PPH etiology. Indeed, it is easily available, with relatively low cost, not using ionizing radiation, and can be used in different settings including the labor room, the operating theater and at the bedside of an affected women. In order to be effective Obstetricians should have an adequate knowledge of postpartum ultrasonography. In this article, we will review the sonographic findings occurring in PPH, in the differential diagnosis of the underlying cause of hemorrhage, that include retained placenta, morbidly adherent placenta, rupture of the uterus uterine, vascular anomalies of the uterine arteries and uterine inversion. We will also provide an algorithm to manage PPH according to the ultrasonographic findings.

Introduction of the Ellavi uterine balloon tamponade into the Kenyan and Ghanaian maternal healthcare package for improved postpartum haemorrhage management: an implementation research study.

OBJECTIVES: Use of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH. DESIGN: A mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months. SETTING: Three Ghanaian (district, regional) and three Kenyan (levels 4-6) healthcare facilities. PARTICIPANTS: Obstetric staff (n=451) working within participating facilities. INTERVENTION: PPH management training courses were conducted with obstetric staff. PRIMARY AND SECONDARY OUTCOME MEASURES: Facility measures of adoption, sustainability and fidelity and individual measures of acceptability and feasibility. RESULTS: All participating hospitals adopted the device during the study period and the majority (52%-62%) of the employed obstetric staff were trained on the Ellavi; sustainability and fidelity to training content were moderate. The Ellavi was suited for this context due to high delivery and PPH burden. Dynamic training curriculums led by local UBT champions and clear instructions on the packaging yielded positive attitudes and perceptions, and high user confidence, resulting in overall high acceptability. Post-training and post-use, ≥79% of the trainees reported that the Ellavi was easy to use. Potential barriers to use included the lack of adjustable drip stands and difficulties calculating bag height according to blood pressure. Overall, the Ellavi can be feasibly integrated into PPH care and was preferred over condom catheters. CONCLUSIONS: The training package and time saving Ellavi design facilitated its adoption, acceptability and feasibility. The Ellavi is appropriate and feasible for use among obstetric staff and can be successfully integrated into the Kenyan and Ghanaian maternal healthcare package. TRIAL REGISTRATION NUMBERS: NCT04502173; NCT05340777.

The use of an obstetric balloon as a pelvic spacer in preventing empty pelvis syndrome after total pelvic exenteration in rectal cancers - A prospective safety and efficacy study for the Bakri balloon.

AIM: Empty pelvis syndrome (EPS) is a source of considerable morbidity following total pelvic exenteration. None of the available methods have been universally successful in mitigating this problem. The aim of this work was to evaluate the safety and efficacy of the obstetric Bakri balloon in preventing empty pelvis syndrome. METHOD: This study was a combined prospective and retrospective study of all total pelvic exenterations for rectal cancers from a single institution performed between October 2013 and May 2022. Since December 2019 the Bakri balloon was used in all patients who provided consent. EPS within 90 days was the primary end point, and included bowel obstruction, pelvic collection and entero-perineal fistula. Comparison with those patients who did not have a Bakri balloon was performed. RESULTS: Seventy-five patients with a Bakri balloon were compared with 96 patients without a balloon placed after pelvic exenteration. No patient experienced an untoward complication from balloon deployment. The incidence of EPS was 13.3% and 22.9% in the Bakri and no Bakri cohorts, respectively (p = 0.110). Every component of EPS was proportionally lower, without statistical significance. Based on point estimates, the number needed to treat to prevent EPS using the Bakri balloon was 10. CONCLUSIONS: Use of the Bakri balloon was safe without serious adverse events. The incidence of EPS after total pelvic exenteration was not statistically different with the use of the Bakri balloon despite a 9.6% reduction. A larger comparative study is needed to evaluate the efficacy of the balloon.

Risk factors for Bakri balloon tamponade failure in the management of postpartum hemorrhage.

OBJECTIVE: To predict risk factors for Bakri balloon tamponade (BBT) failure in the management of postpartum hemorrhage (PPH). METHODS: The data of 599 patients who underwent BBT were retrospectively analyzed from January 1, 2017 to December 31, 2021 in a tertiary hospital in Shanghai, East China. The patients were divided into the failure group and the success group. Failure was defined as the inability to control bleeding, which required surgical interventions. Maternal characteristics, PPH characteristics, PPH management approaches, and maternal complications were compared between the groups. The independent predictors of BBT failure were analyzed by logistic regression analysis. RESULTS: The overall success rate of BBT was 83.0% (497/599). The blood loss before and after balloon insertion in the failure group was significantly greater than that in the success group. Of the 102 failures, B-Lynch suture was performed in one patient, uterine artery embolization was performed in 99 patients (with one failure), and total hysterectomy was performed in three patients. Some risk factors, including twin gestation (odds ratio [OR] 9.68), placenta accreta spectrum with/without placenta previa (OR 4.45), estimated blood loss at least 1135 ml at balloon insertion (OR 3.35), multiparous (OR 2.72), and in vitro fertilization-embryo transfer (OR 2.00) were strongly associated with BBT failure. CONCLUSION: BBT seemed to be a less effective tool in the management of PPH due to placenta accreta spectrum with/without placenta previa and twin gestation.