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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]

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]

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]

Copyright of Ginecología y Obstetricia de México is the property of Federacion Mexicana de Ginecologia y Obstetricia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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]

Copyright of MediSur is the property of Centro Provincial de Informacion de Ciencias Medicas de Cinfuegos and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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. [ABSTRACT FROM AUTHOR]

Objective: To determine the outcomes and factors associated with postpartum haemorrhage (PPH) treatment with condom-catheter uterine balloon tamponade (C-UBT).Design: Prospective observational study.Setting: A secondary healthcare facility in Nigeria.Population: Women with PPH refractory to first-line treatment.Methods: Demographic and clinical characteristics were compared in women with successful and unsuccessful treatment. Univariate and multivariate logistic regression analyses were used to examine the association of these characteristics with successful treatment.Main Outcome Measures: The success rate of C-UBT, factors associated with success, and maternal morbidity rates in both successful and unsuccessful treatment groups.Results: Overall, 203/229 (88.6%) women had successful treatment. Women with successful treatment had lower mean blood loss (1248.8 ± 701.3 ml versus 3434.6 ± 906.6 ml; P < 0.0001), lower occurrence of blood transfusion [139 (68.5%) versus 26 (100%); P < 0.0001], lower intensive care unit admission rates [5 (2.5%) versus 20 (76.9%); P < 0.0001], and lower occurrence of infectious morbidities [3 (1.5%) versus 7 (26.9%); P < 0.0001]. In the regression model with two factors, caesarean section (adjusted odds ratio, aOR 0.17; 95% confidence interval, 95% CI 0.07-0.40) was associated with lower success rates compared with vaginal delivery. In the regression model with three factors, advanced maternal age (aOR 0.31; 95% CI 0.11-0.90) and caesarean section (aOR 0.17; 95% CI 0.07-0.41) were associated with lower success rates in comparison with younger maternal age and vaginal delivery, respectively.Conclusions: Second-line PPH treatment with C-UBT is effective, and is associated with low maternal morbidity rates. Advanced maternal age and caesarean section are associated with lower success rates.Tweetable Abstract: Condom-catheter tamponade is a useful second-line treatment modality for intractable postpartum haemorrhage. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to assess the impact of tamponade when uterotonic agents fail, on the need for surgery or interventional radiology.Material and Methods: All women who received sulprostone for postpartum hemorrhage were retrospectively compared over two periods [December 2008 to December 2010 without use of tamponade (period 1) and June 2011 to June 2013 with use of tamponade (period 2)] in the case of sulprostone failure (STROBE compliant retrospective cohort study). During period 2, interventional radiology or surgery was used only in the case of tamponade failure.Results: 165 women were included (74 for period 1, 91 for period 2). The rate of interventional radiology or surgery significantly decreased from period 1 (21 of 74 women, 28.4%) to period 2 (six of 91 women, 6.6%, p = 0.0003). The rate of assumed failure of uterotonic agents was higher for period 2: 22 of 74 women (29.7%) during period 1, and 41 of 91 (45.1%, p = 0.0439) during period 2. The success rate of tamponade was 92.1% (35 of 38 women).Conclusions: Although the efficacy of tamponade should be viewed in the light of its widespread use, our findings confirm that tamponade significantly reduces the need for interventional radiology or surgery for postpartum hemorrhage treatment. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness and safety of an ultra-low-cost uterine balloon tamponade package (ESM-UBT™) for facility-based management of uncontrolled postpartum haemorrhage (PPH) in Kenya, Sierra Leone, Senegal, and Nepal.Design: Prospective multi-centre case series.Setting: Facilities in resource-scarce areas of Kenya, Sierra Leone, Nepal, and Senegal.Population: Women with uncontrolled postpartum haemorrhage in 307 facilities across the four countries.Methods: A standardised ESM-UBT package was implemented in 307 facilities over 29 months (1 September 2012 to 1 February 2015). Data were collected via a multi-pronged approach including data card completion, chart reviews, and provider interviews. Beginning in August 2014, women who had previously undergone UBT placement were sought and queried regarding potential complications associated with UBT use.Main Outcome Measures: All-cause survival, survival from PPH, and post-UBT use complications (surgery, hospitalisation, antibiotics for pelvic infection) associated with UBT use.Results: 201 UBTs were placed for uncontrolled vaginal haemorrhage refractory to all other interventions. In all, 38% (71/188) of women were either unconscious or confused at the time of UBT insertion. All-cause survival was 95% (190/201). However, 98% (160/163) of women survived uncontrolled PPH if delivery occurred at an ESM-UBT online facility. One (1/151) potential UBT-associated complication (postpartum endometritis) was identified and two improvised UBTs were placed in women with a ruptured uterus.Conclusions: These pilot data suggest that the ESM-UBT package is a clinically promising and safe method to arrest uncontrolled postpartum haemorrhage and save women's lives. The UBT was successfully placed by all levels of facility-based providers. Future studies are needed to further evaluate the effectiveness of ESM-UBT in low-resource settings.Tweetable Abstract: Evidence for ESM-UBT as a clinically promising and safe method to arrest uncontrolled PPH and save women's lives. [ABSTRACT FROM AUTHOR]

Aim: To identify the role of condom catheter in managing postpartum haemorrhage Materials &Methods: This prospective study was done on 180 cases of postpartum haemorrhage, out of which 94 cases were managed by condomcatheter and the remaining casesweremanaged by medical treatment and other surgicalmethods. Results: In majority of the cases PPH was controlled with condom catheter with the mean volume of 389.4 ml but it could be inflated upto 500ml and also bleeding was stopped within 10 minutes in 90.4% cases. Patients did not require further intervention. Conclusion: Thus, it was contemplated in our study that condom catheter is a highly effective, simple to use and economical method in managing postpartum haemorrhage in a developing country like India to save the lives of patients. [ABSTRACT FROM AUTHOR]

The uterine inversion is a rare and severe puerperal complication. Uncontrolled cord traction and uterine expression are the common causes described.We report a case of uterine inversion stage III caused by poor management of the third stage of labor. It was about a 20 years old primigravida referred in our unit for postpartum hemorrhage due to uterine atony. After manual reduction of the uterus, the use of intra uterine balloon tamponade helped to stop the hemorrhage. The uterine inversion is a rare complication that may cause maternel death. The diagnosis is clinical and its management must be immediate to avoid maternal complications. [ABSTRACT FROM AUTHOR]

Copyright of Firat Tip Dergisi is the property of Firat University, Faculty of Medicine and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective To evaluate maternal outcomes following uterine balloon tamponade in the management of postpartum hemorrhage. Design Retrospective case-series. Setting Two French hospitals, a level 3 university referral center and a level 2 private hospital. Population All women who underwent balloon tamponade treatment for primary postpartum hemorrhage. Methods Uterine tamponade was used after standard treatment of postpartum hemorrhage had failed. The study population was divided into two groups, successful cases where the bleeding stopped after the balloon tamponade, and failures requiring subsequent surgery or embolization. Main outcome measures Success rates. Results Uterine tamponade was used in 49 women: 30 (61%) after vaginal delivery and 19 (39%) after cesarean section. Uterine atony was the main cause of hemorrhage (86%). The overall success rate was 65%. Of 17 failures, surgery was required in 16 cases, including hysterectomy in 11, and uterine artery embolization in one case. Demographic and obstetric characteristics did not differ significantly between the success and failure groups. No complications were directly attributed to the balloon tamponade in the postpartum period. Two women had a subsequent full-term pregnancy without recurrence of postpartum hemorrhage. Conclusions Balloon tamponade is an effective, safe and readily available method for treating primary postpartum hemorrhage and could reduce the need for invasive procedures. [ABSTRACT FROM AUTHOR]

PATH, an international nonprofit organization, assessed nearly 40 technologies for their potential to reduce maternal mortality from postpartum hemorrhage and preeclampsia and eclampsia in low-resource settings. The evaluation used a new Excel-based prioritization tool covering 22 criteria developed by PATH, the Maternal and Neonatal Directed Assessment of Technology (MANDATE) model, and consultations with experts. It identified five innovations with especially high potential: technologies to improve use of oxytocin, a uterine balloon tamponade, simplified dosing of magnesium sulfate, an improved proteinuria test, and better blood pressure measurement devices. Investments are needed to realize the potential of these technologies to reduce mortality. [ABSTRACT FROM AUTHOR]

We present the case of a 37-year-old nulliparous woman in whom acute massive uterine bleeding during dienogest therapy was successfully treated using intrauterine balloon tamponade. Abnormal uterine bleeding and several cases of profuse bleeding causing severe anemia in association with dienogest therapy have been reported, but this is the first reported case involving hypovolemic shock. While successful control of postpartum hemorrhage with intrauterine balloon tamponade has been well described, applications for non-obstetric bleeding, particularly in the presence of underlying diseases, such as adenomyosis, have only rarely been reported. This procedure can be easily, promptly, and safely implemented without analgesia, anesthesia, or laparotomy; it can be used with a minimally dilated external cervical os or narrow uterine cavity; and it can preserve fertility. [ABSTRACT FROM AUTHOR]

Background Effective interventions addressing postpartum haemorrhage (PPH) are critically needed to reduce maternal mortality worldwide. Uterine balloon tamponade (UBT) has been shown to be an effective technique to treat PPH in developed countries, but has not been examined in resource-poor settings. Objectives This literature review examines the effectiveness of UBT for the treatment and management of PPH in resource-poor settings. Search strategy Publications were sought through searches of five electronic databases: Medline, Cochrane Reference Libraries, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Embase and Popline. Selection criteria Titles and abstracts were screened for eligibility by two independent reviewers. Each reviewer evaluated the full text of potentially eligible articles by defined inclusion criteria, including the presentation of empirical data and use of UBT in resource-poor settings to treat PPH. Data collection and analysis Full text of all eligible publications was collected and systematically coded. Main results The search identified 13 studies that met the inclusion criteria: six case reports or case series, five prospective studies and two retrospective studies for a total of 241 women. No randomised controlled trials were identified. The studies used various types of UBT, including condom catheter ( n = 193), Foley catheter ( n = 5) and Sengstaken-Blakemore oesophageal tube ( n = 1). In these studies, primarily conducted in tertiary-care settings rather than lower-level health facilities, UBT successfully treated PPH in 234 out of 241 women. Conclusions UBT is an effective treatment for PPH in resource-poor settings. Further study of UBT interventions is necessary to better understand the barriers to successful implementation and use in these settings. [ABSTRACT FROM AUTHOR]

Uterine balloon tamponade has rapidly gained popularity in the management of postpartum haemorrhage. It is a conservative method often utilised before embarking on advanced surgical interventions. The mechanism of action, complications and long-term outcomes are discussed. [ABSTRACT FROM AUTHOR]

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

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 FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]