A novel low-cost uterine balloon tamponade kit to tackle maternal mortality in low-resource settings.

The 3.1 target of the Sustainable Development Goals of the United Nations aims to reduce the global maternal mortality ratio to less than 70 maternal deaths per 100,000 live births by 2030. The last updates on this target show a significant stagnation in the data, thus reducing the chance of meeting it. What makes this negative result even more serious is that these maternal deaths could be avoided through prevention and the wider use of pharmacological strategies and devices to stop postpartum haemorrhage (PPH). PPH is the leading obstetric cause of maternal mortality in low- and middle-income countries (LMICs). Despite low-cost devices based on the uterine balloon tamponade (UBT) technique are already available, they are not safe enough to guarantee the complete stop of the bleeding. When effective, they are too expensive, especially for LMICs. To address this issue, this study presents the design, mechanical characterisation and technology assessment performed to validate a novel low-cost UBT kit, particularly a novel component, i.e., the connector, which guarantees the kit's effectiveness and represents the main novelty. Results proved the device's effectiveness in stopping PPH in a simulated scenario. Moreover, economic and manufacturing evaluations demonstrated its potential to be adopted in LMICs.

Cost-effectiveness of uterine balloon tamponade devices in managing atonic post-partum hemorrhage at public health facilities in India.

OBJECTIVE: Post-partum hemorrhage (PPH) is the leading direct cause of maternal mortality in India. Uterine balloon tamponade (UBT) is recommended for atonic PPH cases not responding to uterotonics. This study assessed cost-effectiveness of three UBT devices used in Indian public health settings. METHODS: A decision tree model was built to assess cost-effectiveness of Bakri-UBT and low-cost ESM-UBT alternatives as compared to the recommended standard of care i.e. condom-UBT intervention. A hypothetical annual cohort of women eligible for UBT intervention after experiencing atonic PPH in Indian public health facilities were evaluated for associated costs and outcomes over life-time horizon using a disaggregated societal perspective. Costs by undertaking primary costing and clinical parameters from published literature were used. Incremental cost per Disability Adjusted Life Years (DALY) averted, number of surgeries and maternal deaths with the interventions were estimated. An India specific willingness to pay threshold of INR 24,211 (USD 375) was used to evaluate cost-effectiveness. Detailed sensitivity analysis and expected value of information analysis was undertaken. RESULTS: ESM-UBT at base-case Incremental Cost-Effectiveness Ratio (ICER) of INR -2,412 (USD 37) per DALY averted is a cost-saving intervention i.e. is less expensive and more effective as compared to condom-UBT. Probabilistic sensitivity analysis however shows an error probability of 0.36, indicating a degree of uncertainty around model results. Bakri-UBT at an ICER value of INR -126,219 (USD -1,957) per DALY averted incurs higher incremental societal costs and is less effective as compared to condom-UBT. Hence, Bakri-UBT is not cost-effective. CONCLUSION: For atonic PPH management in India, condom-UBT offers better value as compared to Bakri-UBT. Given the limited clinical effectiveness evidence and uncertainty in sensitivity analysis, cost-saving result for ESM-UBT must be considered with caution. Future research may focus on generating high quality comparative clinical evidence for UBT devices to facilitate policy decision making.

Healthcare providers experiences of using uterine balloon tamponade (UBT) devices for the treatment of post-partum haemorrhage: A meta-synthesis of qualitative studies.

BACKGROUND: Postpartum haemorrhage (PPH) is a leading cause of maternal mortality and severe morbidity globally. When PPH cannot be controlled using standard medical treatments, uterine balloon tamponade (UBT) may be used to arrest bleeding. While UBT is used by healthcare providers in hospital settings internationally, their views and experiences have not been systematically explored. The aim of this review is to identify, appraise and synthesize available evidence about the views and experiences of healthcare providers using UBT to treat PPH. METHODS: Using a pre-determined search strategy, we searched MEDLINE, CINAHL, PsycINFO, EMBASE, LILACS, AJOL, and reference lists of eligible studies published 1996-2019, reporting qualitative data on the views and experiences of health professionals using UBT to treat PPH. Author findings were extracted and synthesised using techniques derived from thematic synthesis and confidence in the findings was assessed using GRADE-CERQual. RESULTS: Out of 89 studies we identified 5 that met our inclusion criteria. The studies were conducted in five low- and middle-income countries (LMICs) in Africa and reported on the use of simple UBT devices for the treatment of PPH. A variety of cadres (including midwives, medical officers and clinical officers) had experience with using UBTs and found them to be effective, convenient, easy to assemble and relatively inexpensive. Providers also suggested regular, hands-on training was necessary to maintain skills and highlighted the importance of community engagement in successful implementation. CONCLUSIONS: Providers felt that administration of a simple UBT device offered a practical and cost-effective approach to the treatment of uncontrolled PPH, especially in contexts where uterotonics were ineffective or unavailable or where access to surgery was not possible. The findings are limited by the relatively small number of studies contributing to the review and further research in other contexts is required to address wider acceptability and feasibility issues.

Cost-effectiveness of uterine tamponade devices for the treatment of postpartum hemorrhage: A systematic review.

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.

Safety of a condom uterine balloon tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone.

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.

Bakri balloon versus condom-loaded Foley's catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial.

OBJECTIVE: To assess the efficacy and safety of condom-loaded Foley's catheter versus Bakri Balloon in the management of primary atonic post partum hemorrhage (PPH) secondary to vaginal delivery. STUDY DESIGN: This study was single blinded randomized controlled trial conducted at Assiut Woman's Health Hospital, Egypt in the period between October 2014 and December 2015. It Comprised 66 women with primary atonic PPH following vaginal delivery. Eligible participants were randomly assigned to Bakri balloon (group A) or condom-loaded Foley's catheter (group B). The primary outcome was the success of tamponade to stop the uterine bleeding without additional surgical interventions. Secondary outcomes included time between insertion and stoppage of the bleeding, the amount of blood transfusion and maternal complications. RESULTS: Both treatment modalities successfully controlled the primary atonic PPH without a statistically significant difference [30/33(91.0%) and 28/33(84.84%), p = .199; respectively]. However; Bakri balloon required shorter time to stop the uterine bleeding (9.09 min vs. 11.76 min, p = .042; respectively). There was no statistically significant difference between both groups regarding postpartum maternal complications, the vital signs, urine output, hemoglobin and hematocrit levels from before to after tamponade insertion. CONCLUSIONS: Condom-loaded Foley's catheter is as effective as Bakri balloon in the management of primary atonic PPH following vaginal delivery but requires a significant bit longer time to stop the attack.

A low-cost uterine balloon tamponade for management of postpartum hemorrhage: modeling the potential impact on maternal mortality and morbidity in sub-Saharan Africa.

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.

Uterine packing versus Foley's catheter for the treatment of postpartum hemorrhage secondary to bleeding tendency in low-resource setting: A four-year observational study.

OBJECTIVE: To assess the effectiveness and safety of uterine packing versus Foley's catheter tamponade for controlling postpartum hemorrhage (PPH) secondary to bleeding tendency after vaginal delivery. METHODS: This was a prospective observational study conducted on 92 patients with primary PPH due to bleeding tendency following vaginal delivery who were unresponsive to uterotonics and bimanual compression of the uterus. Patients were divided into two groups, Uterine packing group (n = 45) and Foley catheter group (n = 47). The primary outcome was the success rate of the procedure. Secondary outcome addressed the maternal complications. RESULTS: The use of uterine packing resulted in stoppage of active bleeding in 93.3% of cases compared to only 68.1% in the Foley's catheter group (p < 0.05). Although the rate of minor complications namely fever, pain and urinary complaints were higher in the uterine packing group, it does not reach to a significant difference when compared to the Foley's catheter (p > 0.05). Six cases who failed to Foley catheter tamponade underwent emergency hysterectomy with no cases in the uterine packing group. CONCLUSIONS: The use of uterine packing to arrest PPH is simple, quick and safe procedure to avoid further surgical interventions and to preserve the fertility in low-resource setting.

Prioritizing investments in innovations to protect women from the leading causes of maternal death.

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.

Use of uterine balloon tamponade for control of postpartum hemorrhage by community-based health providers in South Sudan.

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.