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.

Improving maternal safety: Usability and performance assessment of a new medical device for the treatment of postpartum haemorrhage.

Postpartum haemorrhage (PPH) is an obstetric emergency causing nearly one-quarter of maternal deaths worldwide, 99% of these in low-resource settings (LRSs). Uterine balloon tamponade (UBT) devices are a non-surgical treatment to stop PPH. In LRSs, low-cost versions of UBT devices are based on the condom balloon tamponade (CBT) technique, but their effectiveness is limited. This paper discusses the experimental study to assess the usability and performance of a medical device, BAMBI, designed as an alternative to current CBT devices. The testing phase involved medical and non-medical personnel and was focused on testing BAMBI's usability and effectiveness compared to a standard CBT solution. We collected measures of the execution time and the procedure outcome. Different training procedures were also compared. Results show a significant preference for the BAMBI device. Besides, medical and non-medical subjects reached comparable outcomes. This aspect is highly relevant in LRSs where the availability of medical personnel could be limited.

Tranexamic acid for reduction of blood loss after Caesarean delivery: a cost-effectiveness analysis of the TRAAP2 trial.

BACKGROUND: Prophylactic administration of tranexamic acid is associated with a reduction of blood loss after Caesarean delivery, but cost-effectiveness for this indication has not been assessed. METHODS: We used data from the TRAAP2 trial, a multicentre, double-blinded, RCT aimed at estimating the efficacy of tranexamic acid for preventing postpartum haemorrhage among women undergoing Caesarean delivery. Women recruited at 27 French maternity hospitals from 2018 to 2020 were enrolled before the procedure if they had a Caesarean delivery before or during labour at 34 or more weeks of gestation. The main outcomes were the cost of hospital stay for delivery and the incremental cost per delivery without complication within 90 days after delivery with tranexamic acid compared with placebo. Differences in costs and the incremental net monetary benefit (INMB) were estimated using linear regression models, and the cost-effectiveness probability of tranexamic acid compared with placebo was estimated through the parametric distribution of the INMB. RESULTS: The proportion of women without complications at day 90 was 70.7% in the tranexamic acid group and 66.0% in the placebo group. Mean total costs until occurrence of a complication of interest were €3321 in the tranexamic acid group and €3260 in the placebo group, resulting in a difference between the two groups of 7.2% and €55 after multiple imputation. The adjusted incremental cost-effectiveness ratio was €762 per additional Caesarean delivery without a complication at 90 days after delivery. At a cost-effectiveness threshold of €10,000, the cost-effectiveness probability of tranexamic acid compared with placebo was 99.9%, varying from 5.8% to 100.0% for thresholds from €0 to €10,000 per additional delivery without a complication at day 90. CONCLUSION: Tranexamic acid for the prevention of blood loss is cost-effective in reducing complications after Caesarean delivery at day 90 postpartum. However, the effect size (in cost and effectiveness) is very low. CLINICAL TRIAL REGISTRATION: NCT03431805.

Tranexamic acid for the prevention of postpartum hemorrhage: a cost-effectiveness analysis.

Postpartum hemorrhage is a significant contributor to maternal mortality worldwide and in the United States. Tranexamic acid (TXA) has been shown to reduce PPH complications although it is not routinely recommended for use as prophylaxis to date. To estimate the cost-effectiveness of alternative risk-dictated strategies utilizing prophylactic tranexamic acid for the prevention of postpartum hemorrhage. We constructed a microsimulation-based Markov decision-analytic model estimating the cost-effectiveness of three alternative risk-dictated strategies for tranexamic acid prophylaxis versus the no prophylaxis in a cohort of 3.8 million pregnant women delivering in the United States. Each strategy differentially modified risk-specific hemorrhage probabilities by preliminary estimates of tranexamic acid's prophylactic efficacy. Outcome measures included incremental costs, quality-adjusted life-years, and outcomes averted. Costs and benefits were considered from the healthcare system and societal perspectives over a lifetime time horizon. All intervention strategies were dominant versus no prophylaxis, implying that they were simultaneously more effective and cost-saving. Prophylaxing delivering women irrespective of hemorrhage risk produced the most favorable results overall, with estimated cost savings greater than $690 million and up to 149,505 PPH cases, 2,933 hysterectomies, and 70 maternal deaths averted, per annual cohort. Threshold analysis suggested that tranexamic acid is likely to be cost-saving for health systems at costs below $190 per gram. Our findings suggest that routine prophylaxis with tranexamic acid would likely result in substantial cost-savings and reductions in adverse maternal outcomes in this context. This study is a cost-effectiveness analysis demonstrating cost-savings and reduction in adverse maternal outcomes with routine tranexamic acid as prophylaxis for post-partum hemorrhage.

Cost-effectiveness and budget impact of heat-stable carbetocin compared to oxytocin and misoprostol for the prevention of postpartum hemorrhage (PPH) in women giving birth in India.

INTRODUCTION: Low- and middle-income countries (LMICs) are committed to achieving the Sustainable Development Goal 3.1 to reduce maternal mortality. The Ministry of Health and Family Welfare of India recommends prophylactic uterotonic administration to every woman following delivery to reduce the risk of postpartum hemorrhage (PPH), as PPH is the leading cause of maternal mortality in LMICs, including India. In 2018, the World Health Organization first recognized heat-stable carbetocin for PPH prevention. Governments are now considering its introduction into their public health systems. METHODS: A decision-tree model was developed from the public healthcare system perspective to compare the value of heat-stable carbetocin versus oxytocin and misoprostol among women giving birth in public sector healthcare facilities in India. The model accounted for differences in PPH risk and costs based on mode of delivery and healthcare setting, as well as provider behavior to mitigate quality concerns of oxytocin. Model outcomes for each prophylactic uterotonic included the number of PPH events, DALYs due to PPH, deaths due to PPH, and direct medical care costs. The budget impact was estimated based on projected uterotonic uptake between 2022-2026. RESULTS: Compared to oxytocin, heat-stable carbetocin avoided 5,468 additional PPH events, 5 deaths, and 244 DALYs per 100,000 births. Projected direct medical costs to the public healthcare system were lowered by US $171,700 (₹12.8 million; exchange rate of ₹74.65 = US$1 from 2 Feb 2022) per 100,000 births. Benefits were even greater when compared to misoprostol (7,032 fewer PPH events, 10 fewer deaths, 470 fewer DALYs, and $230,248 saved per 100,000 births). In the budget impact analysis, India's public health system is projected to save US$11.4 million (₹849 million) over the next five years if the market share for heat-stable carbetocin grows to 19% of prophylactic uterotonics administered. CONCLUSIONS: Heat-stable carbetocin is expected to reduce the number of PPH events and deaths, avoid more DALYs, and reduce costs to the public healthcare system of India. Greater adoption of heat-stable carbetocin for the prevention of PPH could advance India's efforts to achieve its maternal health goals and increase efficiency of its public health spending.

Prevention of postpartum haemorrhage: Economic evaluation of the novel butterfly device in a UK setting.

OBJECTIVES: To explore the cost-effectiveness of a novel PPH device as compared with usual care. DESIGN: A decision analytical model was used to explore the cost-effectiveness of the PPH Butterfly device compared with usual care. This was part of a United Kingdom, UK, clinical trial ISRCTN15452399 using a matched historical cohort who had standard PPH management without the use of the PPH Butterfly device. The economic evaluation was conducted from a UK National Health Service (NHS) perspective. SETTING: Liverpool Women's Hospital, UK. PARTICIPANTS: 57 women with 113 matched controls. INTERVENTION: The PPH Butterfly is a novel device that has been invented and developed in the UK to facilitate bimanual compression of the uterus in the treatment of PPH. MAIN OUTCOME MEASURES: Main outcome measures included healthcare costs, blood loss, and maternal morbidity events. RESULTS: Mean treatment costs in the Butterfly cohort were £3,459.66 as compared with standard care £3,223.93. Treatment with the Butterfly device resulted in decreased total blood loss in comparison with standard care. The Butterfly device had an incremental cost-effectiveness ratio of £3,795.78 per PPH progression avoided (defined as ≤ 1000 ml additional blood loss from device insertion point). If the NHS is prepared to pay £8,500 per PPH progression avoided, then the Butterfly device is cost-effective with a probability of 87 percent. In the PPH Butterfly treatment arm there were 9% fewer cases of massive obstetric haemorrhage (severe PPH of more than 2000mls or more than 4 units of blood transfusion required) recorded as compared with the standard care historical cohort. As a low-cost device, the PPH Butterfly device is cost-effective but can be cost-saving to the NHS. CONCLUSION: The PPH pathway can result in high-cost resource use such as blood transfusion or high dependence unit hospital stays. The Butterfly device is a relative low-cost device in a UK NHS setting with a high probability of being cost-effective. The National Institute for Health and Care Excellence (NICE) can use this evidence in considering the adoption of innovative technologies such as the Butterfly device in the NHS. Extrapolation on an international scale to lower and middle-income countries could prevent mortality associated with PPH.

Economic cost of secondary postpartum haemorrhage: A case-control study at a tertiary hospital in Australia.

BACKGROUND: Secondary postpartum haemorrhage (PPH) is a condition which affects 0.2-3.0% of women. Despite its impact on maternal morbidity, there is a lack of understanding of the cost burden of disease. AIMS: To determine the economic cost of secondary PPH in the postpartum period, compared to the costs for women without this diagnosis. MATERIALS AND METHODS: Data were prospectively collected on a cohort of 97 women who presented with secondary PPH to the emergency department (ED) between July 2020 and February 2021. A case-control design was then used to compare postpartum cost data from these patients to a group of 97 controls who were matched to maternal demographics, and who did not present with secondary PPH. RESULTS: For women with secondary PPH, there were significantly more hospital attendances, and postpartum costs were higher for all cost subcategories across ED, admissions, and outpatient attendances (P < 0.0001), compared to controls. The total cost of postpartum care for 97 patients with secondary PPH was $254 377.62 with an average cost per patient of $2622.45, compared to $26 670.46 for 97 controls with an average cost of $274.95 per patient (P < 0.0001). This demonstrates a 9.5-fold increase in postpartum costs per woman with secondary PPH. CONCLUSIONS: Secondary PPH is an under-researched condition which presents a significant cost burden for the health system. Evidence-based guidelines addressing the prevention and management of secondary PPH may assist in minimising this cost burden for both the health service and the patient.

State Perinatal Quality Collaborative for Reducing Severe Maternal Morbidity From Hemorrhage: A Cost-Effectiveness Analysis.

OBJECTIVE: To evaluate the cost effectiveness of California's statewide perinatal quality collaborative for reducing severe maternal morbidity (SMM) from hemorrhage. METHODS: A decision-analytic model using open source software (Amua 0.30) compared outcomes and costs within a simulated cohort of 480,000 births to assess the annual effect in the state of California. Our model captures both the short-term costs and outcomes that surround labor and delivery and long-term effects over a person's remaining lifetime. Previous studies that evaluated the effectiveness of the CMQCC's (California Maternal Quality Care Collaborative) statewide perinatal quality collaborative initiative-reduction of hemorrhage-related SMM by increasing recognition, measurement, and timely response to postpartum hemorrhage-provided estimates of intervention effectiveness. Primary cost data received from select hospitals within the study allowed for the estimation of collaborative costs, with all other model inputs derived from literature. Costs were inflated to 2021 dollars with a cost-effectiveness threshold of $100,000 per quality-adjusted life-year (QALY) gained. Various sensitivity analyses were performed including one-way, scenario-based, and probabilistic sensitivity (Monte Carlo) analysis. RESULTS: The collaborative was cost effective, exhibiting strong dominance when compared with the baseline or standard of care. In a theoretical cohort of 480,000 births, collaborative implementation added 182 QALYs (0.000379/birth) by averting 913 cases of SMM, 28 emergency hysterectomies, and one maternal mortality. Additionally, it saved $9 million ($17.78/birth) due to averted SMM costs. Although sensitivity analyses across parameter uncertainty ranges provided cases where the intervention was not cost saving, it remained cost effective throughout all analyses. Additionally, scenario-based sensitivity analysis found the intervention cost effective regardless of birth volume and implementation costs. CONCLUSION: California's statewide perinatal quality collaborative initiative to reduce SMM from hemorrhage was cost effective-representing an inexpensive quality-improvement initiative that reduces the incidence of maternal morbidity and mortality, and potentially provides cost savings to the majority of birthing hospitals.

Cost-effectiveness and budget impact of adding tranexamic acid for management of post-partum hemorrhage in the Indian public health system.

BACKGROUND: Postpartum hemorrhage (PPH) is the global leading cause of maternal mortality, affecting nearly 3 to 6 percent of all women giving birth in India. The World Health Organization (WHO) has updated its guidelines to recommend the early use of intravenous (IV) tranexamic acid (TXA) in addition to standard care for all diagnosed PPH cases. This study aimed to assess the cost-effectiveness of introducing TXA for PPH management in the Indian public health system. METHODS: A decision analytic model was built using a decision tree to determine the cost-effectiveness of administering IV TXA to women experiencing PPH within 3 h of birth to existing management with uterotonics and supportive care. Using a disaggregated societal perspective, the costs and consequences for a hypothetical cohort of women experiencing PPH in public health facilities was estimated. The model was populated using probabilities, clinical parameters, and utilities from published literature, while cost parameters were largely derived from a primary economic costing study. The primary outcome of interest was the incremental cost-utility ratio (ICUR). Associated clinical events and net benefits were estimated. One-way and probabilistic sensitivity analysis (PSA) was undertaken. The budget impact was estimated for a national-level introduction. RESULTS: For an estimated annual cohort of 510,915 PPH cases in India, the addition of IV TXA would result in a per-patient disaggregated societal cost of INR 6607 (USD 95.15) with a discounted gain of 20.25 QALYs, as compared to a cost of INR 6486 (USD 93.41) with a discounted gain of 20.17 QALYs with standard care PPH management. At an ICUR value of INR 1470 per QALY gained (USD 21), the addition of IV TXA is cost-effective in Indian public health settings. The intervention is likely to prevent 389 maternal deaths, 177 surgeries, and 128 ICU admissions per 100,000 PPH cases. The findings are robust under uncertainty, with 94.5% of PSA simulations remaining cost-effective. A cumulative increase of 2.3% financial allocation for PPH management over five years will be incurred for TXA introduction. CONCLUSIONS: Addition of tranexamic acid for primary PPH management, as recommended by WHO, is cost-effective in Indian public health settings. Policy guidelines, training manuals, and facility checklists should be updated to reflect this recommendation.

Cost-effectiveness analysis of carbetocin for prevention of postpartum hemorrhage in a low-burden high-resource city of China.

BACKGROUND: Postpartum hemorrhage (PPH) is a major cause of maternal morbidity, and oxytocin is the first-line uterotonic agent for PPH prevention. Clinical findings have reported carbetocin to reduce PPH risk without increasing risk of important side effects. Hong Kong is a low PPH burden and high-resource city in China. We aimed to examine the cost-effectiveness of PPH prevention with carbetocin from the perspective of Hong Kong public healthcare provider. METHODS: A decision-analytic model was developed to simulate clinical and economic outcomes of carbetocin and oxytocin for PPH prevention in a hypothetical cohort of women at the third stage of labor following vaginal birth or Caesarean section (C-section). The model inputs were retrieved from literature and public data. Base-case analysis and sensitivity analysis were performed. The model time horizon was the postpartum hospitalization period. Primary model outcomes included PPH-related direct medical cost, PPH, hysterectomy, maternal death, and quality-adjusted life-year (QALY) loss. RESULTS: In base-case analysis, carbetocin (versus oxytocin) reduced PPH-related cost (by USD29 per birth), PPH ≥500 mL and ≥1,500 mL (by 13.7 and 1.9 per 1,000 births), hysterectomy (by 0.15 per 1,000 births), maternal death (by 0.02 per 1,000 births), and saved 0.00059 QALY per birth. Relative risk of PPH ≥500 mL with carbetocin versus oxytocin, and proportion of child births by C-section were two influential parameters identified in deterministic sensitivity analysis. In probabilistic sensitivity analysis, carbetocin was accepted as cost-effective in >99.7% of the 10,000 Monte Carlo simulations at a willingness-to-pay threshold of zero USD/QALY. CONCLUSION: PPH prevention with carbetocin appeared to reduce major unfavorable outcomes, and save cost and QALYs.

Tranexamic Acid for Postpartum Hemorrhage Treatment in Low-Resource Settings: A Rapid Scoping Review.

Tranexamic acid (TXA) effectively reduces bleeding in women with postpartum hemorrhage (PPH) in hospital settings. To guide policies and practices, this rapid scoping review undertaken by two reviewers aimed to examine how TXA is utilized in lower-level maternity care settings in low-resource settings. Articles were searched in EMBASE, MEDLINE, Emcare, the Maternity and Infant Care Database, the Joanna Briggs Institute Evidence-Based Practice Database, and the Cochrane Library from January 2011 to September 2021. We included non-randomized and randomized research looking at the feasibility, acceptability, and health system implications in low- and lower-middle-income countries. Relevant information was retrieved using pre-tested forms. Findings were descriptively synthesized. Out of 129 identified citations, 23 records were eligible for inclusion, including 20 TXA effectiveness studies, two economic evaluations, and one mortality modeling. Except for the latter, all the studies were conducted in lower-middle-income countries and most occurred in tertiary referral hospitals. When compared to placebo or other medications, TXA was found effective in both treating and preventing PPH during vaginal and cesarean delivery. If made available in home and clinic settings, it can reduce PPH-related mortality. TXA could be cost-effective when used with non-surgical interventions to treat refractory PPH. Capacity building of service providers appears to need time-intensive training and supportive monitoring. No studies were exploring TXA acceptability from the standpoint of providers, as well as the implications for health governance and information systems. There is a scarcity of information on how to prepare the health system and services to incorporate TXA in lower-level maternity care facilities in low-resource settings. Implementation research is critically needed to assist practitioners and decision-makers in establishing a TXA-inclusive PPH treatment package to reduce PPH-related death and disability.

Impact of efforts to prevent maternal deaths due to obstetric hemorrhage on trends in epidemiology and management of severe postpartum hemorrhage in Japan: a nationwide retrospective study.

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.

Implementing Heat-Stable Carbetocin for Postpartum Haemorrhage Prevention in Low-Resource Settings: A Rapid Scoping Review.

Heat-stable carbetocin (HSC), a long-acting oxytocin analogue that does not require cold-chain transportation and storage, is effective in preventing postpartum haemorrhage (PPH) in vaginal and caesarean deliveries in tertiary-care settings. We aimed to identify literature documenting how it is implemented in resource-limited and lower-level maternity care settings to inform policies and practices that enable its introduction in these contexts. A rapid scoping review was conducted with an 8-week timeframe by two reviewers. MEDLINE, EMBASE, Emcare, the Joanna Briggs Institute Evidence-Based Practice Database, the Maternity and Infant Care Database, and the Cochrane Library were searched for publications in English, French, and Spanish from January 2011 to September 2021. Randomized and non-randomized studies examining the feasibility, acceptability, and health system considerations in low-income and lower-middle-income countries were included. Relevant data were extracted using pretested forms, and results were synthesized descriptively. The search identified 62 citations, of which 12 met the eligibility criteria. The review did not retrieve studies focusing on acceptability and health system considerations to inform HSC implementation in low-resource settings. There were no studies located in rural or lower-level maternity settings. Two economic evaluations concluded that HSC is not feasible in terms of cost-effectiveness in lower-middle-income economies with private sector pricing, and a third one found superior care costs in births with PPH than without. The other nine studies focused on demonstrating HSC effectiveness for PPH prevention in tertiary hospital settings. There is a lack of evidence on the feasibility (beyond cost-effectiveness), acceptability, and health system considerations related to implementing HSC in resource-constrained and lower-level maternity facilities. Further implementation research is needed to help decision-makers and practitioners offer an HSC-inclusive intervention package to prevent excessive bleeding among pregnant women living in settings where oxytocin is not available or of dubious quality.

Tranexamic acid for the treatment of postpartum hemorrhage: a cost-effectiveness analysis.

BACKGROUND: Postpartum hemorrhage is a leading cause of pregnancy-related morbidity and mortality. Recent data have demonstrated that tranexamic acid reduces death because of bleeding when used as a treatment for postpartum hemorrhage. The World Health Organization now recommends tranexamic acid as a first-line treatment for postpartum hemorrhage; however, data are not yet available on the frequency of use in the United States, where tranexamic acid is currently recognized as an adjunct treatment for postpartum hemorrhage. OBJECTIVE: We aimed to strengthen the current evidence that tranexamic acid should be recognized as a first-line treatment for postpartum hemorrhage, even in high-resource countries. Furthermore, we aimed to determine whether early administration of tranexamic acid (within 3 hours of diagnosis) is a cost-effective strategy for reducing maternal morbidity and mortality from postpartum hemorrhage in the United States. STUDY DESIGN: A decision-analytical model was designed to compare the outcomes and costs of the administration of tranexamic acid in the treatment of postpartum hemorrhage. Moreover, this model was used to compare outcomes for early administration with those of routine use. The interventions compared were 1 g of intravenous tranexamic acid or matching placebo. The risks analyzed in the model were death because of hemorrhage and laparotomy to control bleeding. Probabilities, utilities, and costs were derived from literature. Quality-adjusted life-years were calculated using a discounted life expectancy rate of 3%. Cost-effectiveness was determined on the basis of a willingness-to-pay threshold of $100,000 per quality-adjusted life year. RESULTS: The administration of tranexamic acid to a theoretical cohort of 100,000 women would prevent 11 maternal deaths, 6 postpartum laparotomies after vaginal delivery, and 112 reoperations after cesarean delivery. This would lead to an increase in 329 quality-adjusted life years and a total cost savings of $15.39 million. Furthermore, if tranexamic acid were administered early (within 3 hours of postpartum hemorrhage diagnosis) to the same theoretical cohort, 16 maternal deaths owing to hemorrhage, 9 laparotomies, and 155 reoperations would be prevented. This amounts to an increase in 438 quality-adjusted life years and an annual cost savings of $23.15 million. A sensitivity analysis showed that the administration of tranexamic acid was the dominant strategy at all probabilities of maternal death owing to hemorrhage >0.00002. When the cost of tranexamic acid was varied, the administration of tranexamic acid remained dominant up to a cost of $267 per administration in the United States if given within the first 3 hours. Furthermore, in a Monte Carlo probabilistic sensitivity analysis, the early administration of tranexamic acid remained the dominant strategy (both lowered costs and improved outcomes) in 99.8% of models. CONCLUSION: Early administration of tranexamic acid was a cost-effective strategy for reducing maternal morbidity and mortality owing to postpartum hemorrhage in the United States.

Cost-effectiveness analysis of carbetocin versus oxytocin for the prevention of postpartum hemorrhage following vaginal birth in the United Kingdom.

AIMS: To assess the cost-effectiveness of carbetocin versus oxytocin for the prevention of postpartum hemorrhage (PPH) following vaginal birth from the perspective of the UK National Health Service (NHS). MATERIALS AND METHODS: A decision tree model was designed to analyze the cost per PPH event avoided associated with utilizing carbetocin versus oxytocin for prophylactic treatment of PPH in women following vaginal birth from a UK perspective. It modelled the potential for women to require an additional uterotonic after prophylaxis, and to still experience a PPH event and receive associated treatment. Inpatient recovery and follow-up periods post-PPH were also included in the model. Costs associated with drug acquisition and administration, PPH management (i.e. additional staffing and possible operating theater and high dependency unit utilization), inpatient hospitalization, and follow-up visits were all considered. Adverse event management costs were not included. Resource utilization varied depending on the severity of the PPH event (as defined by the amount of blood lost). PPH events avoided were estimated. In an exploratory analysis, quality adjusted life years (QALYs) were estimated as well. RESULTS: In the deterministic base case, costs were £55 lower and PPH events were 0.0342 lower per woman with carbetocin use compared to oxytocin use. Across the cohort of 100 women the reduction in PPH events led to the largest cost savings (£4,233 saved) out of all cost categories, with total cost savings of £5,495. Carbetocin utilization amongst the entire cohort led to 3.42 avoided PPH events compared to oxytocin utilization, comprised of 3.03 fewer mild/moderate PPH events and 0.39 fewer severe PPH events. Carbetocin utilization led to 0.0001 additional QALYs per woman. CONCLUSION: Carbetocin utilization leads to lower prophylactic treatment costs and less PPH events versus oxytocin when utilized for the prevention of PPH following vaginal birth in the UK.

Cost Implications of Using Carbetocin Injection to Prevent Postpartum Hemorrhage in a Canadian Urban Hospital.

OBJECTIVE: Recent World Health Organization (WHO) recommendations regarding uterotonics for the prevention of postpartum hemorrhage (PPH) state that carbetocin should be considered a first-line prophylactic agent for all births where its cost is comparable to other effective uterotonics. This study evaluated whether a room temperature stable formulation of carbetocin met this recommendation in a Canadian urban hospital setting. METHODS: A decision tree model was developed to assess the financial implications of replacing oxytocin with carbetocin as a first-line prophylactic agent for PPH prevention in a Greater Toronto Area (GTA) hospital. The analysis accounted for the mode of delivery, efficacies of carbetocin and oxytocin in PPH prevention, occurrence of PPH-related health outcomes, and health care resource costs for PPH interventions. RESULTS: This study found that a GTA hospital, with 3242 deliveries per year, could save over CAD $349 000 annually by switching to room temperature stable carbetocin for PPH prevention. Carbetocin was able to lower institution costs by reducing the use of health care resources for PPH management in low-risk and high-risk PPH patients. The cost-saving potential of carbetocin relative to oxytocin was largely attributed to its greater efficacy in preventing the consequences of PPH. CONCLUSION: The use of room temperature stable carbetocin as a first-line prophylactic agent for PPH prevention meets WHO recommendations regarding uterotonics for PPH in a GTA hospital. The model from this study can be used to determine the financial impact of switching from oxytocin to carbetocin in other jurisdictions while diversifying a hospital's pool of PPH prophylactic agents.

Barriers inhibiting effective detection and management of postpartum hemorrhage during facility-based births in Madagascar: findings from a qualitative study using a behavioral science lens.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries, and is the most common direct cause of maternal deaths in Madagascar. Studies in Madagascar and other low-income countries observe low provider adherence to recommended practices for PPH prevention and treatment. Our study addresses gaps in the literature by applying a behavioral science lens to identify barriers inhibiting facility-based providers' consistent following of PPH best practices in Madagascar. METHODS: In June 2019, we undertook a cross-sectional qualitative research study in peri-urban and rural areas of the Vatovavy-Fitovinany region of Madagascar. We conducted 47 in-depth interviews in 19 facilities and five communities, with facility-based healthcare providers, postpartum women, medical supervisors, community health volunteers, and traditional birth attendants, and conducted thematic analysis of the transcripts. RESULTS: We identified seven key behavioral insights representing a range of factors that may contribute to delays in appropriate PPH management in these settings. Findings suggest providers' perceived low risk of PPH may influence their compliance with best practices, subconsciously or explicitly, and lead them to undervalue the importance of PPH prevention and monitoring measures. Providers lack clear feedback on specific components of their performance, which ultimately inhibits continuous improvement of compliance with best practices. Providers demonstrate great resourcefulness while operating in a challenging context with limited equipment, supplies, and support; however, overcoming these challenges remains their foremost concern. This response to chronic scarcity is cognitively taxing and may ultimately affect clinical decision-making. CONCLUSIONS: Our study reveals how perception of low risk of PPH, limited feedback on compliance with best practices and consequences of current practices, and a context of scarcity may negatively affect provider decision-making and clinical practices. Behaviorally informed interventions, designed for specific contexts that care providers operate in, can help improve quality of care and health outcomes for women in labor and childbirth.

Prevalence and risk factors of severe postpartum hemorrhage: a retrospective cohort study.

BACKGROUND: Although maternal deaths are rare in developed regions, the morbidity associated with severe postpartum hemorrhage (SPPH) remains a major problem. To determine the prevalence and risk factors of SPPH, we analyzed data of women who gave birth in Guangzhou Medical Centre for Critical Pregnant Women, which received a large quantity of critically ill obstetric patients who were transferred from other hospitals in Southern China. METHODS: In this study, we conducted a retrospective case-control study to determine the prevalence and risk factors for SPPH among a cohort of women who gave birth after 28 weeks of gestation between January 2015 and August 2019. SPPH was defined as an estimated blood loss ≥1000 mL and total blood transfusion≥4 units. Logistic regression analysis was used to identify independent risk factors for SPPH. RESULTS: SPPH was observed in 532 mothers (1.56%) among the total population of 34,178 mothers. Placenta-related problems (55.83%) were the major identified causes of SPPH, while uterine atony without associated retention of placental tissues accounted for 38.91%. The risk factors for SPPH were maternal age < 18 years (adjusted OR [aOR] = 11.52, 95% CI: 1.51-87.62), previous cesarean section (aOR = 2.57, 95% CI: 1.90-3.47), history of postpartum hemorrhage (aOR = 4.94, 95% CI: 2.63-9.29), conception through in vitro fertilization (aOR = 1.78, 95% CI: 1.31-2.43), pre-delivery anemia (aOR = 2.37, 95% CI: 1.88-3.00), stillbirth (aOR = 2.61, 95% CI: 1.02-6.69), prolonged labor (aOR = 5.24, 95% CI: 3.10-8.86), placenta previa (aOR = 9.75, 95% CI: 7.45-12.75), placenta abruption (aOR = 3.85, 95% CI: 1.91-7.76), placenta accrete spectrum (aOR = 8.00, 95% CI: 6.20-10.33), and macrosomia (aOR = 2.30, 95% CI: 1.38-3.83). CONCLUSION: Maternal age < 18 years, previous cesarean section, history of PPH, conception through IVF, pre-delivery anemia, stillbirth, prolonged labor, placenta previa, placental abruption, PAS, and macrosomia were risk factors for SPPH. Extra vigilance during the antenatal and peripartum periods is needed to identify women who have risk factors and enable early intervention to prevent SPPH.

[The Role of Oxytocin in the Prevention of Postpartum Hemorrhage in Low-Resource Settings]. / O Papel da Ocitocina na Profilaxia da Hemorragia Pós-Parto em Locais com Recursos Limitados.

INTRODUCTION: Postpartum hemorrhage remains one of the leading causes of maternal death globally. Oxytocin is the uterotonic agent of choice for the prophylaxis of this complication. However, its use in low-resource settings is associated with clinical, political, economic and cultural constraints. The goal of this article is to describe the use of oxytocin for postpartum hemorrhage prophylaxis in low-resource settings. MATERIAL AND METHODS: A literature review on the topic was carried out, and 24 articles were included. RESULTS: The information was organized into seven sections: the evaluation of the efficacy of oxytocin compared to other uterotonics, the use of oxytocin in home births, the training of healthcare professionals, the quality of the available oxytocin, the new formulations, the risks associated with the use of uterotonic and the adopted health policies. DISCUSSION: Despite the progress achieved widespread access to oxytocin for postpartum hemorrhage prophylaxis in low-resource settings is less than desirable. The main difficulties encountered were the shortage of skilled healthcare professionals for oxytocin administration, deficiencies concerning the quality of the drug and the inadequacy of available clinical guidelines. CONCLUSION: In order to reduce maternal mortality caused by postpartum hemorrhage in low-resource settings, it is essential to improve the knowledge of healthcare professionals, to implement good practices on the use of uterotonics, to optimize resource management and to overcome cultural barriers that prevent the demand for health services.

Introdução: A hemorragia pós-parto mantém-se como uma das principais causas de morte materna a nível global. A ocitocina é o uterotónico de eleição na profilaxia desta complicação. Contudo, a sua utilização em locais com recursos limitados associa-se a constrangimentos de foro clínico, político, económico e cultural. O objetivo deste artigo é rever o uso da ocitocina na profilaxia da hemorragia pós-parto em locais com recursos limitados.Material e Métodos: Foi efetuada uma revisão da literatura sobre o tema, selecionando-se 24 artigos.Resultados: A informação foi organizada em sete secções: a avaliação da eficácia da ocitocina relativamente a outros uterotónicos, a utilização da ocitocina em partos domiciliários, a capacitação dos profissionais de saúde, a qualidade da ocitocina disponibilizada nestes locais, as novas formulações, os riscos inerentes à utilização de uterotónicos e as políticas de saúde adotadas.Discussão: Apesar dos progressos alcançados, verificámos que o acesso à profilaxia da hemorragia pós-parto com ocitocina em locais com recursos limitados está aquém do desejável. As principais dificuldades encontradas foram o défice de profissionais de saúde qualificados na administração da ocitocina, as deficiências na qualidade do fármaco e a desadequação das normas de orientação clínica existentes.Conclusão: Para reduzir a mortalidade materna por hemorragia pós-parto em locais de recursos limitados é imprescindível melhorar a capacitação dos profissionais, implementar boas práticas no uso de uterotónicos, otimizar a gestão de recursos e transpor as barreiras culturais impeditivas da procura dos serviços de saúde.

Cost of hospital care of women with postpartum haemorrhage in India, Kenya, Nigeria and Uganda: a financial case for improved prevention.

OBJECTIVE: Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care. METHODS: The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed. We collected data from all women who had PPH, as well as a random sample of women without PPH. Cost data was collected for the cost of stay, PPH interventions, transfusions and medications for 2966 women. We analyzed the difference in cost of care at a facility level between women who experienced a PPH event and those who did not. Key findings The mean cost of care of a woman experiencing PPH in the study sites in India, Kenya, Nigeria, and Uganda exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. CONCLUSION: Our results quantify the increased cost of PPH of up to 4.1 times that for a birth without PPH. PPH cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on uterotonics for the prevention of PPH or other interventions used to treat PPH. Trial registration HRP Trial A65870; UTN U1111-1162-8519; ACTRN12614000870651; CTRI/2016/05/006969, EUDRACT 2014-004445-26. Date of registration 14 August 2014 Access to quality, effective lifesaving medicines in low and middle-income countries remains a major barrier to reducing maternal deaths from bleeding after childbirth. Information on to what extent treatments for bleeding increases the cost of care of women after childbirth is important for informed resource allocation. We collected data from all women who had bleeding after childbirth, as well as a random sample of women without bleeding in selected hospitals in India, Kenya, Nigeria, and Uganda. Cost data was collected for the cost of stay and interventions to manage bleeding for 2966 women. We compared the difference in cost of care between women who experienced a bleeding event and those who did not. The mean cost of care of a woman with bleeding in the study sites exceeded the cost of care of a woman who did not experience PPH by between 21% and 309%. There was a large variation in cost across hospitals within a country and across countries. Our results indicate an increased cost of bleeding of up to 4.1 times that for birth without bleeding. Effective prevention reduces the cost of care. Cost information can help countries to evaluate options across different conditions and in the formulation of appropriate guidelines for intrapartum care, including rational selection of quality-assured, effective medicines. This information can be applied to national assessment and adaptation of international recommendations such as the World Health Organization's recommendations on medications for the prevention of bleeding after childbirth or other interventions used to treat bleeding.