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

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. [ABSTRACT FROM AUTHOR]

The World Health Organization (WHO) recently published a new recommendation on the use of the uterine balloon tamponade for the treatment of postpartum hemorrhage. The recommendation that uterine balloon tamponade should be used only where there is already access to other postpartum hemorrhage treatments (including immediate recourse to surgery) has proved controversial. It is especially problematic for those working in low-level health care facilities in under-resourced settings, where there are already programs that have introduced low-cost uterine balloon tamponade devices for use, even in settings where recourse to surgical interventions is not possible. However, there are now two separate randomized trials that both unexpectedly show unfavorable outcomes in these settings when a condom catheter uterine balloon tamponade device was introduced. Considering the balance of potential benefits and these safety concerns, the WHO postpartum hemorrhage guideline panel therefore recommends that uterine balloon tamponade should be used only in contexts where other supportive postpartum hemorrhage interventions are available if needed.

Background: The use of uterine balloon tamponade (UBT) devices for intrauterine packing and management of vaginal bleeding by uterine atony has shown promising results in improving the quality of care and reducing maternal mortality. Objective: This report aims to provide an overview of progress made in implementing UBT devices in northern Cote d'Ivoire. Material and methods: A four-year retrospective study was conducted in the North-East (163,645), North-Center (351,909), and North-West (57,983). In 2017, UBT was adopted by members of the healthcare system. Subsequently, 5 national and 32 regional trainers have been trained. The training session was a theoretical and practical program with a low simulator. UBT is a male condom tied to a urinary catheter, filled with liquid. Positive outcomes included stopping bleeding, avoiding the need for surgery, and preventing maternal deaths (MD). In 2018, 3,515 UBT devices were distributed. In 2019, monitoring tools and transmission circuits of the data were validated. In 2020, the collection of data and local manufacturing was launched. Results: During the process, 978 health workers, mainly midwife (52.0%) and nurses (32.2%) out of the 1,295 assigned were trained. The number of trained individuals decreased from 209 in 2019 to 160 in 2020. A total of 1,715 UBT devices were locally manufactured, adding to the existing gift of 5,080 devices, with total availability of 6,795. The distribution of devices increased from 2017 to 2019 but decreased in 2020. Success rates increased from 87.3% in 2017 (365/418) to 95.0% in 2019 (556/585) and slightly decreased in 2020 to 98.0% (681/695). Adverse outcomes (144/2,193), included MD (35/2,193) and medical evacuation to the surgical center (109/2,193). Conclusion: The implementation of UBT in northern Cote d'Ivoire successfully reduced maternal death rates caused by immediate post-partum hemorrhage (IPPH). However, to ensure sustainability, further improvements are needed, including increased monitoring, ongoing training, and device availability.

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. Synopsis: Uterine balloon tamponade is efficient in controlling PPH. In Brazil, El Hennawy and Alves handmade devices are described; the Alves UBT is faster in use. [ABSTRACT FROM AUTHOR]

Objective: To determine the efficacy and safety of Foley's catheter for uterine tamponade in the management of postpartum hemorrhage due to uterine atony. Material and methods: This observational study was conducted in the tertiary care hospital i.e. Department of Obstetrics and Gynecology Khyber Teaching Hospital Peshawar. A hundred patients with non-traumatic post-partum hemorrhage were enrolled from January 2021 to 31st July 2022. After the failure of medical therapy, Foleys catheter was placed in the intrauterine cavity for twenty-four hours to achieve uterine tamponade to stop bleeding in patients with postpartum hemorrhage. All the variables including vital signs and the amount of blood collected in the bag attached to the Foley's catheter were noted and entered into a proforma. The main outcome measures were success rate in controlling hemorrhage, the time required to stop bleeding, and subsequent morbidity and technical difficulties. The average time taken to control bleeding was four minutes. Data were analyzed by SPSS 23. Results: The age of the patients ranged from 20-36 years while gestational age and parity were noted to be 37-39 weeks and 1-6 respectively. Foleys catheter for uterine tamponade was found successful in 98% of our patients who had uterine atony. Bleeding was stopped in 98 patients with this procedure. The Foleys catheter used was of 16 Fr size which is commonly available in our labor room setup. The total amount of fluid filled in the Foleys catheter was 240ml. The mean duration in which the catheter was in situ was 12.5 hours. Three patients had infective morbidity. Conclusion: The use of Foley's catheter for uterine tamponade in the management of postpartum hemorrhage is a highly successful procedure. [ABSTRACT FROM AUTHOR]

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. Identified facilitators to implementation of the Every Second Matters uterine balloon tamponade should be leveraged for future implementation in other low‐resource settings. [ABSTRACT FROM AUTHOR]

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. Introduction of a uterine balloon tamponade device for managing severe postpartum hemorrhage in health facilities in India significantly reduced maternal death and/or invasive procedures. [ABSTRACT FROM AUTHOR]

BACKGROUND Retained products of conception (RPOC) is a rare complication following second-trimester delivery or pregnancy termination, often leading to significant hemorrhage. Diagnosed via ultrasound or CT, RPOC requires surgical intervention based on endometrial thickness. Risk factors include second-trimester abortion and use of placental forceps. We report a case of RPOC diagnosed 1 month postpartum after using a Bakri balloon for atonic hemorrhage during full-term delivery. CASE REPORT The patient, a 32-year-old woman with a history of 4 pregnancies and 3 births, conceived via frozen embryo transfer, which was her first infertility treatment. At 36 weeks of gestation, blood tests revealed a hemoglobin level of 10.4 g/dl. She delivered vaginally at 38 weeks 2 days, but postpartum uterine contractions were poor, leading to significant bleeding. Oxytocin administration and uterine massage failed to improve contractions, so a Bakri balloon was inserted. The total blood loss was 2263 cc, and 6 units of RBCs were transfused. The next day, the Bakri balloon was removed, and ultrasonography confirmed the absence of retained placenta before discharge on postpartum day 5. However, at her 1-month checkup, a retained placenta was diagnosed, requiring further intervention. The patient declined follow-up. CONCLUSIONS We encountered a case of RPOC 1 month after using a Bakri balloon. Although the relationship between the 2 remains unclear, it may be preferable to avoid such treatment in the future.

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. [ABSTRACT FROM AUTHOR]

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

Objective: Objective of the study was to study the efficacy of condom tamponade to arrest bleeding in cases of atonic postpartum haemorrhage (PPH) unresponsive to uterotonics. Methods: We conducted prospective observational study, in the Department of Obstetrics and Gynecology of Govt. Medical college & hospital, Aurangabad for 2 yrs. UBT (uterine balloon tamponade) was applied to women who developed atonic PPH following childbirth unresponsive to uterotonics. UBT was inflated with normal saline. Clinical success was defined as control of bleeding following balloon insertion without further intervention. Results: Out of the 385 women who had atonic PPH, 63 were managed with insertion of condom balloon catheter after failed medical management. Success rate was 61 out of 63 cases (96.8%). In 3 cases bleeding persisted even after 30 minutes and surgical intervention done for 2 of the 3 cases; in the third patient bleeding was arrested 30 minutes after tamponade application (1.63%). In 9 (14.2%) patients UBT was expelled spontaneously within 6 hours, out of it 2 required further surgical intervention due to uncontrolled PPH. In 93.6% cases bleeding got controlled within 15 -30 mins of condom tamponade insertion, the balloon was inflated for an average of 18 hours before removal. Conclusions: Condom catheter is a noninvasive, effective, conservative method of PPH management. In cases of failure it provides a temporary tamponade effect and time to prepare for other interventions.

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

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

Postpartum hemorrhage (PPH) is among the most significant causes of maternal death worldwide. The time of diagnosing and the proper management of hemorrhage are essential in preventing maternal mortality. The current study aimed to evaluate the effect of Bakri balloon on the management of PPH. Bakri balloon was effective in controlling PPH of 92.3% of patients. The most frequent indications for using Bakri balloon was uterine atony (46.1%). Furthermore, Bakri balloon is among the simplest and low invasive methods that can be used to control PPH before invasion methods, like hysterectomy.

Objective: Postpartum hemorrhage is a common obstetrical emergency. Because the majority of cases respond to conservative medical therapies, trainees have limited clinical experience with hemostatic sutures or placement of a Bakri intrauterine balloon for refractory postpartum hemorrhage. Simulations provide an invaluable adjunct to resident education to learn and practice these hemostatic techniques. We aimed to create a low-cost, reproducible simulation model to prepare residents for uterine atony interventions such as B-Lynch, Bakri balloon placement, and uterine artery ligation., Study Design: Using low-cost supplies, a reusable, life-sized recent postpartum uterus was constructed from pieces of sheepskin and sewn together with various expired suture. The sheepskin material allowed for repeated, secure placement of B-Lynch and O'Leary sutures and Bakri balloons, as well as offering the required compressibility to simulate a boggy uterus. Finally, sections of a red robin catheter were incorporated along the lateral lower borders of the model to simulate blood vessels for practicing uterine artery ligations., Results: The model was used about 50 times over the span of 3 years to practice uterine hemostatic suturing. Residents found this model lifelike, accurate in size, and multifunctional for practicing these various techniques. The sheepskin material proved to be very resistant to repeated suturing, and also provided strong suture pull through strength. The durability of the sheepskin material demonstrates that this model can be used for repeated simulations or individual practice., Conclusion: The sheepskin uterus model provides trainees a realistic, low-cost, reproducible, simulation of a hypotonic uterus and allows for multiple modalities for managing postpartum hemorrhage., Key Points: · We provide instructions for the creation of a sheepskin model for obstetric hemorrhage simulation.. · We demonstrate use of the sheepskin model in various obstetric hemorrhage management techniques.. · We demonstrate that the model is durable and lifelike based off of resident feedback.., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Uterine tamponade is widely promoted for treating refractory postpartum hemorrhage (PPH); however, its cost‐effectiveness may vary depending on unit costs and setting. Objective: To review available data on cost‐effectiveness of uterine tamponade devices when used for PPH treatment. Search strategy: PubMed and EMBASE were searched (1980 to January 2020), as well as the National Health Services Economic Evaluation database from inception (1995) to March 2015. Selection criteria: Eligible studies were any type of economic evaluation, or effectiveness studies that provided cost or economic data. Data collection and analysis: Two reviewers independently screened studies, extracted data, and assessed quality. Main results: Eleven studies using a range of devices (condom catheter, uterine suction devices, Bakri, Inpress, Ellavi) were identified. Cost of condom catheter devices or kits ranged from US$0.64 to US$6, whereas purpose‐designed device costs were up to US$400. Two studies that took a health system perspective assessed the cost‐effectiveness of using uterine balloon tamponade and suggested that it was highly cost‐effective because of the low cost per disability‐adjusted life‐year averted, although both used effect estimates from case series. Conclusions: Evidence on the cost‐effectiveness of uterine tamponade devices was limited and not generalizable. Rigorous economic evaluations based on updated effect estimates are needed. Synopsis: Evidence on the cost‐effectiveness of uterine tamponade devices was limited and further economic evaluations based on updated effect estimates are needed. [ABSTRACT FROM AUTHOR]

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Abstract Background Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine balloon tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine balloon tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Methods Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Results Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. Conclusion The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.

Objective: According to WHO, the maternal mortality ratio in Kyrgyz Republic is 76 cases per 100.000 live births and is the highest among the Central Asian and Eastern European countries. It is necessary to study and implement minimally invasive postpartum hemorrhage treatment methods to prevent massive obstetric hemorrhage. Methods: A prospective study of 35 cases of the use of intrauterine balloon tamponade (UBT) for the treatment of hypotonic postpartum hemorrhage was conducted. The indicators were assessed to evaluate the effectiveness of UBT. Results: Hemostatic effect after UBT was achieved in 30 cases (85.7%), the average total blood loss was 664.57 (117.83) ml; reduced need for blood products, high doses of prostaglandins, large volume of fluid maintenance was observed. Breastfeeding started within the first 30 – 60 minutes after birth in 88.6% of cases. Conclusion: UBT fully complies with the strategy for preservation of the reproductive potential in women, allows to improve medical and economic indicators.

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

Objective: To assess the effectiveness of introducing condom-catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low- and middle-income settings.Design: Stepped wedge, cluster-randomised trial.Setting: Eighteen secondary-level hospitals in Uganda, Egypt and Senegal.Population: Women with vaginal delivery from October 2016 to March 2018.Methods: Use of condom-catheter UBT for PPH management was introduced using a half-day training and provision of pre-packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect).Main Outcome Measures: Combined IR of PPH-related invasive surgery and/or maternal death.Results: There were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH-related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07-15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods.Conclusions: Introduction of condom-catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH-related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role.Tweetable Abstract: Stepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH-related surgery or death. [ABSTRACT FROM AUTHOR]

Abstract Background Postpartum hemorrhage (PPH) is the leading cause of maternal deaths worldwide. This study sought to quantify the potential health impact (morbidity and mortality reductions) that a low-cost uterine balloon tamponade (UBT) could have on women suffering from uncontrolled PPH due to uterine atony in sub-Saharan Africa. Methods The Maternal and Neonatal Directed Assessment of Technology (MANDATE) model was used to estimate maternal deaths, surgeries averted, and cases of severe anemia prevented through UBT use among women with PPH who receive a uterotonic drug but fail this therapy in a health facility. Estimates were generated for the year 2018. The main outcome measures were lives saved, surgeries averted, and severe anemia prevented. Results The base case model estimated that widespread use of a low-cost UBT in clinics and hospitals could save 6547 lives (an 11% reduction in maternal deaths), avert 10,823 surgeries, and prevent 634 severe anemia cases in sub-Saharan Africa annually. Conclusions A low-cost UBT has a strong potential to save lives and reduce morbidity. It can also potentially reduce costly downstream interventions for women who give birth in a health care facility. This technology may be especially useful for meeting global targets for reducing maternal mortality as identified in Sustainable Development Goal 3.

Objective: Rupture of uterine artery pseudoaneurysm (UAP) is a life-threatening event after childbirth. Hysterectomy or uterine arterial embolization was often needed for hemostasis. However, such procedures may cause severe morbidities for these women. To estimate the efficacy of uterine balloon tamponade (UBT) for controlling ruptured UAP bleeding, a retrospective analysis in a single teaching hospital was performed. Materials and methods: We reviewed the medical record of Juntendo University Hospital in 2015. All the women diagnosed with UAP were recruited to this study and management for UAP was investigated. Results: Three women were treated with UBT for ruptured UAP. All cases achieved hemostasis. One case had recurrent UAP after 24 h of UBT, and was retreated with UBT for a longer duration. The UAP was obliterated after more than 2 days of UBT in all cases. Conclusion: UBT has potential as a therapeutic technique not only for treatment of a ruptured UAP but also for obliteration of a UAP.

Objective Postpartum hemorrhage (PPH) is the most common cause of maternal mortality and morbidity worldwide, most of which occurs in resource-poor settings. Placement of a uterine balloon may be life-saving in uncontrolled PPH. The Every Second Matters for Mothers-Uterine Balloon Tamponade (ESM-UBT) device is an ultra-low-cost uterine balloon designed for global access. The purpose of this study was to evaluate the mechanical properties of the ESM-UBT device. Study design Intraluminal pressures, diameters, and burst volumes of condom uterine balloons and Foley catheter balloons of ESM-UBT devices were measured in open air and inside uterus models. Condom uterine balloons were tested with uterus model sizes of 100, 250, and 500mL. The condom-catheter O-ring attachment tensile strength was also evaluated. Results All 28 samples of ESM-UBT condom uterine balloons maintained their integrity for at least 3 hours when subjected to pressures of 200 mm Hg or greater across each of the tested uterine volumes. No Foley catheter balloons burst after instillation of 30mL, O-rings withstood forces of 15.4 ± 2.1 N, and condom uterine balloons stretched to 35.8 ± 2.1 cm without loss of integrity. Conclusion The mechanical properties of the ESM-UBT device make it attractive for scale across resource-poor settings.

Obstetric hemorrhage after delivery complicates 10.5% of births worldwide and is related to high perinatal morbidity and mortality. Its management includes medical treatment and if refractory, it will be necessary to resort to a surgical treatment based on uterine tamponade with gauze or balloon, uterine compression sutures, pelvic devascularization and arterial embolization. If all these procedures are not effective, then a radical treatment such as obstetric hysterectomy should be performed. The case of a 37.5 week, nulliparous pregnant woman, attended at the Dr. Gustavo Aldereguía Lima Hospital in Cienfuegos is presented. Labor is induced due to premature rupture of membranes that evolves into the active phase and it is decided to perform instrumental delivery by forceps to shorten the expulsive period by non-physiological variety and alteration of fetal well-being. A female 4025 g weight newborn was obtained, with greater obstetric hemorrhage due to uterine atony, which does not resolve with conventional medical treatment and it was decided to perform conservative management of the uterus by means of Barki's balloon uterine compression. Uterine contractility and a satisfactory clinical evolution are achieved. This surgical procedure was first described worldwide by the end of the 20th century and was introduced in Cuba in 2016. Since then, the Cienfuegos province has implemented these conservative practices. In the case presented it was possible to reduce bleeding. In addition it reduces obstetric morbidity and mortality and preserves fertility in the patient with unmet parity [ABSTRACT FROM AUTHOR]

The Alves handmade intrauterine balloon is a new device which shows promising results for the effective treatment of PPH with intrauterine tamponade. The Alves handmade IUB components are affordable and more resistant to obstruction than other handmade IUBs. [ABSTRACT FROM AUTHOR]

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., Competing Interests: Financial Disclosure Methodius G. Tuuli reports that money was paid to his prior institution from Alydia Inc for research. Tracy L. Jackson did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Abstract Objective Uterine tamponade by fluid-filled balloons is now an accepted method of controlling postpartum hemorrhage. Available tamponade balloons vary in design and material, which affects the filling attributes and volume at which they rupture. We aimed to characterize the filling capacity and pressure-volume relationship of various tamponade balloons. Study Design Balloons were filled with water ex vivo. Intraluminal pressure was measured incrementally (every 10 mL for the Foley balloons and every 50 mL for all other balloons). Balloons were filled until they ruptured or until 5,000 mL was reached. Results The Foley balloons had higher intraluminal pressures than the larger-volume balloons. The intraluminal pressure of the Sengstaken-Blakemore tube (gastric balloon) was initially high, but it decreased until shortly before rupture occurred. The Bakri intraluminal pressure steadily increased until rupture occurred at 2,850 mL. The condom catheter, BT-Cath, and ebb all had low intraluminal pressures. Both the BT-Cath and the ebb remained unruptured at 5,000 mL. Conclusion In the setting of acute hemorrhage, expeditious management is critical. Balloons that have a low intraluminal pressure-volume ratio may fill more rapidly, more easily, and to greater volumes. We found that the BT-Cath, the ebb, and the condom catheter all had low intraluminal pressures throughout filling.