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.

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.

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 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.

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.

Traditional uterine tamponade and vacuum-induced uterine tamponade devices in obstetrical hemorrhage management.

Obstetrical hemorrhage is the leading cause of maternal morbidity and mortality worldwide, and the rates of severe hemorrhage are increasing. There is a crucial need to expand treatment options for hemorrhage to address this global crisis. Over the last decade, the evolution of hemorrhage control devices has contributed to advancements in obstetrical hemorrhage management. The number of existing hemorrhage control devices and techniques has increased markedly in recent years, and new devices are in development. The current evidence for established and investigational hemorrhage control devices has been summarized in this review. Of note, 2 main categories of devices exist: traditional uterine tamponade and vacuum-induced uterine tamponade. Although traditional intrauterine balloon tamponade devices are currently used widely in postpartum hemorrhage management, novel hemorrhage control devices and techniques have been developed. These include the minisponge tamponade device, the Jada System, a modified Bakri balloon technique, and a suction tube uterine tamponade technique. Reassuring safety data and preliminary efficacy data from pilot studies of these novel techniques support the powerful role intrauterine devices can play in obstetrical hemorrhage management. This review aimed to improve awareness of device options so that continued efforts can be made to integrate new technology into hemorrhage management protocols. Well-designed studies inclusive of new hemorrhage control devices are essential to understanding where new technology fits into preexisting obstetrical hemorrhage algorithms. In addition, access to new tamponade technology remains limited on a global scale. Programs aimed at both increasing access to devices and expanding educational initiatives are essential to make new technology a standard component for hemorrhage management.

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)

Risk Factors for Intrauterine Tamponade Failure in Postpartum Hemorrhage.

OBJECTIVE: To identify factors associated with intrauterine tamponade failure after vaginal or cesarean delivery. METHODS: This was a nationwide population-based cohort study that used data from the French Programme de Médicalisation des Systèmes d'Information. This study compared the failure and effectiveness of intrauterine tamponade among all women who received the procedure in France from January 1, 2019, to December 31, 2019. Failure was defined as the use of a second-line method (uterine artery embolization, conservative or radical surgery, or death) within 7 days of intrauterine tamponade. Factors associated with intrauterine tamponade failure were identified by univariate analyses and tested using multivariate generalized logistic regression models (with a random intercept on institution) to obtain adjusted odds ratio (aOR) and 95% CI statistics. RESULTS: A total of 39,193 patients presented with postpartum hemorrhage in 474 French maternity wards. Of these patients, 1,761 (4.5%) received intrauterine tamponade for persistent bleeding. The effectiveness rate of intrauterine tamponade was 88.9%. For 195 women (11.1%), a second-line method was indicated. Patients for whom intrauterine tamponade failed had a higher maternal age, a lower mean gestational age, and more frequent instances of placental abnormalities, preeclampsia, cesarean birth, and uterine rupture. The multivariate analysis revealed that cesarean birth (aOR 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-4.0), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0) were independently associated with intrauterine tamponade failure. CONCLUSION: Cesarean delivery, preeclampsia, and uterine rupture are associated with intrauterine tamponade failure in the management of postpartum hemorrhage.

[Analysis of the efficacy and related influencing factors of pelvic packing in the treatment of intractable postpartum hemorrhage after emergency perinatal hysterectomy].

Objective: To investigate the effect of pelvic packing on the control of intractable postpartum hemorrhage after emergency perinatal hysterectomy (EPH). Methods: Eleven cases with complete clinical data of pelvic packing due to failure of hemostasis after EPH were collected to evaluate the outcome, complications, hospital stay of pregnant women, and to analyze the factors affecting the effect of pelvic packing. The cases included patients who were admitted to the Third Affiliated Hospital of Guangzhou Medical University after pelvic packing treatment in the other hospital due to continuous bleeding after EPH or who were referred to our hospital for pelvic packing treatment due to continuous bleeding after EPH from January 2014 to August 2021. Results: The median gestational week of 11 pregnant women was 38.3 weeks(38.0-39.9 weeks) , and the methods of termination of pregnancy were cesarean section in 7 cases (7/11) and vaginal delivery in 4 cases (4/11). The median time between postpartum hemorrhage and pelvic tamponade was 10 hours (5-57 hours), the median amount of bleeding was 8 500 ml(4 800-15 600 ml) , the median number of pelvic tamponade was 3 pieces (2-7 pieces), and the median retention time of gauze pad was 6.0 days (3.0-6.0 days). The median frequency of laparotomy in this pregnancy was 3 times (2-3 times), with a maximum of 4 among the 11 cases, the first pelvic packing was successful in hemostasis in 9 cases, and the final successful treatment in all of the 11 cases. All parturients had hemorrhagic shock (11/11) and disseminated intravascular coagulation (11/11) before pelvic packing. Other common complications were multiple organ dysfunction syndrome (9/11), cardiac arrest (4/11), deep vein thrombosis (3/11), septic shock (3/11), and intestinal obstruction (1/11). All parturients took out the gauze after the coagulation function returned to normal and there was no active bleeding. The recovery time of coagulation function in 11 cases was 3 days (3-5 days), the retention time of gauze pad was 6 days (3-6 days), the median length of stay in intensive care unit was 14 days (11-26 days), and the median total length of stay was 22 days (16-49 days). Conclusions: Pelvic packing could be used as a temporary strategy for intractable postpartum hemorrhage after EPH, which provides a key time for injury control resuscitation for patients with unstable vital signs. This technology provides an opportunity for referral to superior medical institutions and further treatment.

Mixed methods evaluation of simulation-based training for postpartum hemorrhage management in Guatemala.

BACKGROUND: To assess if simulation-based training (SBT) of B-Lynch suture and uterine balloon tamponade (UBT) for the management of postpartum hemorrhage (PPH) impacted provider attitudes, practice patterns, and patient management in Guatemala, using a mixed-methods approach. METHODS: We conducted an in-country SBT course on the management of PPH in a governmental teaching hospital in Guatemala City, Guatemala. Participants were OB/GYN providers (n = 39) who had or had not received SBT before. Surveys and qualitative interviews evaluated provider knowledge and experiences with B-Lynch and UBT to treat PPH. RESULTS: Multiple-choice surveys indicated that providers who received SBT were more comfortable performing and teaching B-Lynch compared to those who did not (p = 0.003 and 0.005). Qualitative interviews revealed increased provider comfort with B-Lynch compared to UBT and identified multiple barriers to uterine balloon tamponade implementation. CONCLUSIONS: Simulation-based training had a stronger impact on provider comfort with B-Lynch compared to uterine balloon tamponade. Qualitative interviews provided insight into the challenges that hinder uptake of uterine balloon tamponade, namely resource limitations and decision-making hierarchies. Capturing data through a mixed-methods approach allowed for more comprehensive program evaluation.

Unilateral uterine artery embolization and Bakri tamponade balloon insertion in the treatment of acute puerperal uterine inversion: a case report.

BACKGROUND: Acute puerperal uterine inversion is rare but may cause massive postpartum blood loss due to uterine atony. Therefore, these patients must be diagnosed, and uterine replacement must be performed as soon as possible. However, in some cases, active bleeding due to uterine atony becomes uncontrollable, even though the uterine inversion itself is treated. In these cases, additional treatments, including surgical procedures, are needed. CASE PRESENTATION: A 41-year-old Japanese woman, gravida 1, para 0, was hospitalized for labor induction at 40 weeks and 3 days of gestational age. She had a vacuum-assisted delivery after 3 days of oxytocin administration, but acute uterine inversion occurred. Although replacement of the inverted uterus was successful by manual repositioning and Bakri balloon tamponade insertion, massive postpartum hemorrhage caused by uterine atony became uncontrollable. In this situation, since disseminated intravascular coagulation had developed, we used uterine artery embolization to stop the bleeding. After detecting the pseudo-aneurysmal sac and tortuous vessels of the right uterine artery, transcatheter right-sided uterine artery embolization was performed. Thirteen days after uterine artery embolization, she was discharged with no complications. CONCLUSIONS: In cases of disseminated intravascular coagulation caused by massive postpartum bleeding, uterine artery embolization may often be selected. In our case, since we performed angiography to detect the main bleeding site, the hemorrhage could be stopped with unilateral uterine artery embolization alone, without hysterectomy.

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.

Bakri Balloon: an easy, useful and effective option for the treatment of postpartum haemorrhage.

We report our postpartum haemorrhage protocol focussing on the use of Bakri Balloon, describing its placement and affixing method, effectiveness rates, risk factors that might contribute to Bakri Balloon's failure and complications associated. We designed a retrospective study including 147 cases where a Bakri Balloon was necessary to control the postpartum uterine bleeding to assess the efficacy and to determine which clinical, obstetric or delivery variables could be associated with successful treatment. Failed treatment was defined when surgery or any other technique was needed after a Bakri Balloon placement in order to control uterine bleeding. For statistical analysis, we developed a descriptive analysis and a univariate logistic regression study.IMPACT STATEMENTWhat is already known on this subject? Postpartum haemorrhage is one of the most severe situations in the immediate postpartum period entailing a major cause of maternal morbimortality if an accurate and quick intervention is not carried out.What do the results of this study add? The use of Bakri Balloon was effective in 94.6% of patients. No statistically significant differences were found in the success rates according to obstetric or delivery characteristics. No major complications occurred due to the placement of a Bakri Balloon. In the failure group, blood loss was significantly higher and all required blood products transfusion.What are the implications of these findings for clinical practice and/or further research? Bakri Balloon is an easy-to-use device that provides an effective therapeutic alternative to more aggressive techniques in postpartum haemorrhages when medical treatment fails. Obstetrics or delivery characteristics should not entail a contraindication in its use. A continuous training system based on an agreed protocol is recommended in order to guarantee the best care possible.

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.