Cost-effectiveness of uterine balloon tamponade devices in managing atonic post-partum hemorrhage at public health facilities in India (original) (raw)
Related papers
BMJ Open, 2021
ObjectivePostpartum haemorrhage (PPH) is the worldwide leading cause of preventable maternal mortality. India offers free treatment for pregnancy and related complications in its public health facilities. Management with uterine balloon tamponade (UBT) is recommended for refractory atonic PPH cases. As part of health technology assessment to determine the most cost-effective UBT device, this study estimated costs of atonic PPH management with condom-UBT, Every Second Matters (ESM) UBT and Bakri balloon UBT in public health system of Maharashtra, India.DesignHealth system cost was estimated using primary economic microcosting, data from Health Management Information System and published literature for event probabilities.SettingsFour public health facilities from the state of Maharashtra, India representing primary, secondary and tertiary level care were chosen for primary costing.Outcome measuresUnit, package and annual cost of atonic PPH management with three UBT devices were measu...
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2017
To evaluate the cost-effectiveness of condom uterine balloon tamponade (UBT) for control of severe postpartum hemorrhage (PPH) due to uterine atony versus standard PPH care in Kenya. A cross-sectional analysis was conducted using cost data collected from 30 facilities in Western Kenya from April 15 to July 16, 2015. Effectiveness data were derived from the published literature. The modeling analysis was performed from the health-system perspective for a cohort of women who gave birth in 2015. Sensitivity analyses tested the robustness of model estimates. Costs were in 2015 US dollars. Compared with standard care with no uterine packing, condom UBT could prevent 1255 hospital transfers, 430 hysterectomies, and 44 maternal deaths. At 5or5 or 5or15 per UBT device, the incremental cost per disability-adjusted life year (DALY) averted was 26or26 or 26or40, respectively. If uterine packing was assumed to be done with standard care, the cost per DALY averted was 164whentheUBTpricewas164 when the UBT price was 164whentheUBTpricewas5 and $1...
International Journal of Reproduction, Contraception, Obstetrics and Gynecology
Background: World Health Organisation recommends using Uterine Balloon Tamponade (UBT) for refractory atonic postpartum haemorrhage (PPH) management provided treatment protocols and surgical recourse is possible. Methods: This review collated literature from three electronic databases between January 2010 to December 2019 to compare clinical effectiveness, safety and use related parameters for condom-UBT, Bakri balloon and Every Second Matters (ESM) UBT devices used in India. Results: Thirty-three eligible studies reported effectiveness in managing all PPH causes ranging from 84.2% to 98.3% for condom-UBT and from 65.3% to 94.8% for Bakri-UBT. Three ESM-UBT studies reported PPH survival rates of 94% to 97.4%. Mean UBT effectiveness in controlling atonic PPH was 92.3% for condom-UBT, 84.3% for Bakri-UBT and 97.3% for ESM-UBT. Condom-UBT and Bakri-UBT were comparable across parameters whereas limited ESM-UBT evidence reported success in preventing maternal deaths. Conclusions: For li...
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2018
Maternal death is the greatest health disparity globally, with postpartum hemorrhage the most common cause. As senior leaders in obstetrics and maternal health from Bolivia, Canada, Colombia, Côte d'Ivoire, Honduras, India, Kenya, Nepal, Niger, Norway, Peru, Tanzania, the UK, the USA, and Zambia, we are deeply disturbed by recent calls for randomized controlled trials (RCTs) of uterine balloon tamponade (UBT) in women with uncontrolled postpartum hemorrhage (PPH). Our collective experience, in combination with mounting evidence, unequivocally supports the effectiveness of commercial and condom UBTs in averting death and disability from PPH associated with atonic uterus. We believe it would be highly unethical to embark on an RCT of UBT, now or in the future, unless compared with a proven equivalent intervention. This article is protected by copyright. All rights reserved.
Journal of SAFOG, 2021
Background: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one-quarter of all maternal deaths globally. Refractory PPH is defined as PPH failed to respond to the medical line of management and requiring second-line treatment in the form of balloon tamponade, compression sutures, stepwise devascularization, or hysterectomy. Aim and objective: To assess the effectiveness of balloon tamponade in the management of refractory PPH and reduction in surgical interventions with the use of uterine balloon tamponade. Materials and methods: Prospective data of all 53 women with refractory PPH who underwent balloon tamponade after failed medical management that were collected over a period of 1.5 years were analyzed. Results: The study includes women from 20 to 35 years of age. The mean age of the study population was 24.81 ± 4.468 years. The estimated amount of blood loss in this study ranges from 700 to 2000 mL, and the mean estimated amount of blood loss was 1260.38 ± 333.02 mL. The success rate of balloon tamponade alone was 84.90%, while when combined with additional surgical intervention-compression sutures and stepwise devascularization-overall success rate increased up to 98.11% in this study, while one patient underwent rescue hysterectomy despite balloon tamponade. The failure rate was 1.89%. Conclusion: UBT is novel innovation for the management of refractory PPH, and real-time blood loss assessment through Bakri balloon alerts and guides the surgeon in major decisions before proceeding to rescue hysterectomy. Our study recommends the use of balloon tamponade as a primary tool before proceeding for surgical interventions in case if uterotonics fail to manage PPH. Clinical significance: Balloon tamponade is simple, easy, and cost-effective intervention, especially in low resource setting for reducing maternal morbidity and mortality due to refractory PPH.
BMC pregnancy and childbirth, 2018
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. 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, uterin...
BMJ open, 2016
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). Qualitative assessment and analysis of a subgroup extracted from a larger database that contains all UBT device uses among ESM-UBT trained health providers. Health facilities in Kenya and Senegal with ESM-UBT training and capable of performing emergency hysterectomies. 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. The impact of ESM-UBT on decisions regarding emergency hysterectomy in cases of uncontrolled PPH. 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...
BMJ Open
ObjectivesUse of intrauterine balloon tamponades for refractory postpartum haemorrhage (PPH) management has triggered recent debate since effectiveness studies have yielded conflicting results. Implementation research is needed to identify factors influencing successful integration into maternal healthcare packages. The Ellavi uterine balloon tamponade (UBT) (Ellavi) is a new low-cost, preassembled device for treating refractory PPH.DesignA mixed-methods, prospective, implementation research study examining the adoption, sustainability, fidelity, acceptability and feasibility of introducing a newly registered UBT. Cross-sectional surveys were administered post-training and post-use over 10 months.SettingThree Ghanaian (district, regional) and three Kenyan (levels 4–6) healthcare facilities.ParticipantsObstetric staff (n=451) working within participating facilities.InterventionPPH management training courses were conducted with obstetric staff.Primary and secondary outcome measuresFa...
BMC Pregnancy and Childbirth
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 paramete...
Healthcare, 2021
Background: Postpartum haemorrhage (PPH) is an unpredictable obstetric emergency that requires a multidisciplinary approach. Bakri balloon tamponade (BBT) is recommended when PPH does not respond to medical treatment. Nowadays few published studies have performed a multivariate analysis to determine the variables independently associated with BBT failure. Methods: Our study purpose was to determine the variables independently associated with BBT failure: first, in a large single-centre cohort study between 2010 and 2020, and second, in a systematic literature review using Medline and the Cochrane Library. Maternal and perinatal variables, PPH characteristics, technique-related variables and complications were recorded in the case series study, comparing between successful and failed BBT patients. Study characteristic and variables significantly associated with BBT failure were recorded in the systematic review. All studies used a logistic regression test. Results: The case series in...