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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., (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

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., (© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Objective: To assess the efficacy, effectiveness, and safety of uterine balloon tamponade for treating postpartum hemorrhage., Study Design: We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine balloon tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine balloon tamponade for treating postpartum hemorrhage (number of uterine balloon tamponade success cases/total number of women treated with uterine balloon tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm., Results: Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine balloon tamponade success rate was 85.9% (95% confidence interval, 83.9-87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine balloon tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine balloon tamponade vs no uterine balloon tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02-16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine balloon tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14-0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine balloon tamponade than that which did not use uterine balloon tamponade (3.0/1000 vs 5.1/1000; P < .01). A cluster randomized trial reported that the frequency of postpartum hemorrhage-related invasive procedures and/or maternal death was significantly higher after uterine balloon tamponade introduction than before uterine balloon tamponade introduction (11.6/10,000 vs 6.7/10,000; P = .04). Overall, the frequency of complications attributed to uterine balloon tamponade use was low (≤6.5%)., Conclusion: Uterine balloon tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine balloon tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine balloon tamponade introduction and use., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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.

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: To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device., Methods: In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement., Results: Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25)., Conclusion: The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony., (© 2017 International Federation of Gynecology and Obstetrics.)

Objective: To understand healthcare providers' experiences with improvised uterine balloon tamponade (UBT) for the management of uncontrolled postpartum hemorrhage (PPH)., Methods: In a qualitative descriptive study, in-depth semi-structured interviews were conducted between November 2014 and June 2015 among Kenyan healthcare providers who had previous experience with improvising a UBT device. Interviews were conducted, audio-recorded, and transcribed., Results: Overall, 29 healthcare providers (14 nurse-midwifes, 7 medical officers, 7 obstetricians, and 1 clinical officer) were interviewed. Providers perceived improvised UBT as valuable for managing uncontrolled PPH. Reported benefits included effectiveness in arresting hemorrhage and averting hysterectomy, and ease of use by providers of all levels of training. Providers used various materials to construct an improvised UBT. Challenges to improvising UBT-e.g. searching for materials during an emergency, procuring male condoms, and inserting fluid via a small syringe-were reported to lead to delays in care. Providers described their introduction to improvised UBT through both formal and informal sources. There was universal enthusiasm for widespread standardized training., Conclusion: Improvised UBT seems to be a valuable second-line treatment for uncontrolled PPH that can be used by providers of all levels. UBT might be optimized by integrating a standard package across the health system., (Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Objective: To understand healthcare providers' experience of incorporating uterine balloon tamponade (UBT) into the national postpartum hemorrhage (PPH) clinical pathway after UBT training., Methods: In a qualitative study, semi-structured interviews were undertaken with healthcare providers from 50 centers in Freetown, Sierra Leone, between May and June 2014. All eligible healthcare providers (undergone UBT training, actively conducted deliveries, and treated cases of PPH since UBT training) on duty at the time of center visit were interviewed., Results: Sixty-one providers at 47 facilities were interviewed. Bleeding was controlled in 28 (93%) of 30 cases of UBT device placement. Participants reported that UBT devices were easy to insert with only minor challenges, and enabled providers to manage most cases of uncontrolled PPH at their own facility and to refer others in a stable condition. Reported barriers to optimal UBT use included insufficient training and practical experience, and a scarcity of preassembled UBT devices. Facilitators of UBT use included widespread acceptance of UBT, comprehensive and enthusiastic training, and ready availability of UBT devices., Conclusion: UBT-used either as a primary endpoint or en route to obtaining advanced care-has been well accepted and integrated into the national PPH pathway by providers in health facilities in Freetown., (Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Objectives: To assess the impact of a every second matters for mothers and babies uterine balloon tamponade package (ESM-UBT) on provider decisions regarding emergency hysterectomy in cases of uncontrolled postpartum haemorrhage (PPH)., Design: Qualitative assessment and analysis of a subgroup extracted from a larger database that contains all UBT device uses among ESM-UBT trained health providers., Setting: Health facilities in Kenya and Senegal with ESM-UBT training and capable of performing emergency hysterectomies., Participants: All medical doctors who had placed a UBT for uncontrolled PPH subsequent to implementation of ESM-UBT at their facility, and who also had the capabilities of performing emergency hysterectomies., Primary Outcome Measures: The impact of ESM-UBT on decisions regarding emergency hysterectomy in cases of uncontrolled PPH., Results: 30 of the 31 medical doctors (97%) who fulfilled the inclusion criteria were independently interviewed. Collectively the interviewed medical doctors had placed over 80 UBT devices for uncontrolled PPH since ESM-UBT implementation. All 30 responded that UBT devices immediately controlled haemorrhage and prevented women from being taken to emergency hysterectomy. All 30 would continue to use UBT devices in future cases of uncontrolled PPH., Conclusions: These preliminary data suggest that following ESM-UBT implementation, emergency hysterectomy for uncontrolled PPH may be averted by use of uterine balloon tamponade., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Objective: To understand provider perceptions and experiences following training in the use of a condom-catheter uterine balloon tamponade (UBT) as second-line treatment for uncontrolled postpartum hemorrhage (PPH) in health facilities in Kenya., Methods: As part of a qualitative study, interviews of facility-based providers who had managed PPH following comprehensive PPH training were conducted between February and April 2014. Facilities were purposively sampled to represent a range of experience with UBT, facility size, and geography. Interviews continued until thematic saturation was achieved. Interview transcripts were analyzed for themes., Results: Overall, 68 providers from 29 facilities were interviewed, of whom 31 reported experience with UBT placement (25 midwives, 2 clinical officers, 4 medical officers). Qualitative analysis revealed several major themes. Providers used UBT appropriately within the PPH algorithm, although the timing and clinical severity of patients varied. UBT was most commonly used when bleeding was unresponsive to uterotonics, hysterectomy was unavailable, and referral times long. Providers reported that bleeding was arrested following UBT use in all except one patient, who had a suspected coagulopathy. Most providers described UBT as technically easy to use, although three described initial balloon displacement., Conclusion: UBT has been readily accepted by providers at all levels of training and is being incorporated into the existing PPH management algorithm in Kenya., (Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Objective: To determine whether use of uterine balloon tamponade (UBT) for management of uncontrolled postpartum hemorrhage (PPH) by community-based providers in a resource-limited setting could be feasible, effective, and safe., Methods: In rural South Sudan, community providers were trained and equipped with a simple UBT device consisting of a catheter, condom, and syringe. Snowball sampling identified cases of UBT use since training. Semi-structured interviews were conducted among community providers, referral facility providers, patients, and patient family members. Interview transcripts were analyzed using qualitative methods., Results: Thirteen cases were identified and 24 interviews related to community-based UBT use were conducted. Qualitative analysis revealed several major themes. Community providers applied UBT in appropriate clinical situations. UBT was effective for controlling PPH, even among severely ill patients. Referral was difficult and lengthy owing to the austere setting, but simple UBT appeared to mitigate these challenges. Communities had some initial fears, yet ultimately embraced UBT. Equipment and supplies were largely maintained. There was universal satisfaction with UBT among patients, family members, and providers. One death occurred among the 13 cases, although it was probably not attributable to PPH., Conclusion: Training and UBT device provision are simple, affordable, and effective for managing uncontrolled PPH in a resource-limited setting., (Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

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.