Solution to Technical Difficulties of Uterine Balloon Tamponade Placement in Primary PPH Management: A Retrospective Case Series

Objective: The aim of this study was to devise and enforce a simple yet effective method of condom placement for IUBT while dealing with all the technical difficulties in a poor resource setup to control primary PPH to save life of mother. Methodology: It is a retrospective case series study that is based on the hospital data obtained from Gynecology and Obstetrics Department of Sheikh Zayed Hospital, Rahim Yar Khan for a period of 8 months (July 2019 to Feb 2020) . Patients with persistent primary PPH after medical management who were given intra-uterine balloon tamponade (IUBT) were included in this study after evaluation for possible risk factors of PPH. Sample size was kept 30 with power of test at 80% and level of significance at 5%. Statistical assessment of the variables was done and the data was analyzed with SPSS v.21. Results: The 30 female patients, included in this study, had mean age of 30.3±6.06 years ranging from 17 to 39 years. Condom IUBT was successfully placed in 28(93.3%) patients by using 4 ring forceps applied on cervix and tied together with a gauze to keep the balloon in utero in order to control bleeding of PPH while in 2(6.66%) patients; it was unsuccessful due to inexperience of the operating staff. Out of these 28 patients with successful IUBT placement, condom based intra-uterine balloon tamponade was successful in controlling bleeding of PPH in 26(92.86%) patients while in 2(7.14%) patients, bleeding was not controlled and they underwent surgical interventions. Conclusion: Condom based Intra-uterine balloon tamponade is a simple yet effective method to control bleeding in primary postpartum hemorrhage but needs positive re-enforcement in the form of awareness/training sessions for the healthcare staff. Keywords: Catheter, Post-Partum Morbidity, Condom, Intra-Uterine Balloon Tamponade, Hemorrhage, Hysterectomy

Mixed Methods Evaluation of Simulation-Based Training for Postpartum Hemorrhage Management in Guatemala

Background To assess if simulation-based training (SBT) of B-lynch suture and uterine balloon tamponade (UBT) for the management of postpartum hemorrhage (PPH) impacted provider attitudes, practice patterns, and patient management in Guatemala, using a mixed-methods approach. Methods We conducted an in-country SBT course on the management of PPH in a governmental teaching hospital in Guatemala City, Guatemala. Participants were OB/GYN providers (n = 39) who had or had not received SBT before. Surveys and qualitative interviews evaluated provider knowledge and experiences with B-lynch and UBT to treat PPH. In addition, a retrospective chart review was performed to evaluate management of PPH over a 2-year period before and after the introduction of SBT. Results Multiple-choice surveys indicated that providers who received SBT were more comfortable performing and teaching B-lynch compared to those who did not (p = 0.003 and 0.005). Qualitative interviews revealed increased provider comfort with B-lynch compared to UBT and identified multiple barriers to uterine balloon tamponade implementation. Chart review demonstrated an increased use of UBT after the introduction of simulation-based training, though not statistically significant (p = 0.06) in contrast to no change in B-lynch use. Conclusions Simulation-based training had a stronger impact on provider comfort with B-lynch compared to uterine balloon tamponade. Qualitative interviews provided insight into the challenges that hinder uptake of uterine balloon tamponade, namely resource limitations and decision-making hierarchies. Capturing data through a mixed-methods approach allowed for more comprehensive program evaluation in low and middle income countries (LMICs).

A study of uterine balloon tamponade for the management postpartum haemorrhage using Bakri balloon

Background: PPH is the most common cause of maternal morbidity and mortality around the world. Incidence of PPH is 2-4% following vaginal delivery and 6% following cesarean delivery in India. Uterine atony is the most common cause of PPH. Treatment of PPH involves medical treatment and surgical management. In between medical and surgical management of PPH comes uterine balloon tamponade which is simple, less invasive and can be managed with minimal training.Methods: A retrospective cohort study was done for 2 years at Vanivilas hospital, Bangalore medical college and research centre, Bangalore, Karnataka. Cases of atonic PPH managed using Bakri balloon were included in the study. The objective of the study was to study the effectiveness of uterine balloon tamponade using Bakri balloon in the management of atonic PPH and to study the maternal outcome.Results: In this study total of 50 cases were included. Women were in the age group of 18 to 33years. Regarding obstetric history, 22 (44%) were primigravida and 28 (56%) was multigravida. Among these 50 cases 8 (16%) women had undergone caesarean delivery and 42(84%) had vaginal delivery. All women received blood transfusion, 17 (34%) received blood and blood components (like PRBC, FFP AND platelets) and 33 (66%) cases received only PRBC transfusion. In these 50 cases, 32 (64%) required ICU admission for monitoring, remaining 18 (36%) were monitored in the labor-room. Bakri balloon was effective in 49 cases among 50. Success rate was 98%.Conclusions: Intrauterine balloon tamponade using Bakri balloon is effective for control of atonic PPH in majority of cases.

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.

A case series of post-partum haemorrhage managed using Ellavi uterine balloon tamponade in a rural regional hospital

Uterine balloon tamponade (UBT) should be attempted once emergency measures have been applied and medical treatment for post-partum haemorrhage (PPH) resulting from an atonic uterus has failed. Sinapi Biomedical (Pty) Ltd developed the Ellavi UBT, a free-flow pressure-controlled UBT unit. The device is affordable for use in lesser-resourced countries. A case series of Ellavi UBT used by medical officers in a rural regional hospital without specialist supervision was conducted. This case series was conducted in St Elizabeth’s Hospital in Lusikisiki, South Africa. The hospital serves as the regional hospital for the Ingquza Hill Subdistrict in the Eastern Cape Province. The Nelson Mandela Academic Hospital (NMAH) in Mthatha is the tertiary referral hospital. Workshops were conducted on the use of Ellavi UBT, and devices were made freely available to the hospital. The case series included 10 patients. Six patients delivered by caesarean section, and four had normal vertex deliveries. All patients had additional oxytocin infusions, and eight patients received misoprostol. Following the insertion and inflation of the Ellavi UBT, the PPH stopped in seven patients, was much reduced in one patient and reduced in one patient. In one case, the Ellavi UBT had no effect on the bleeding. All 10 patients were referred to the NMAH. All patients in the case series had good outcomes. The insertion of the Ellavi UBT and subsequent referral proved to be feasible in a rural regional hospital. All patients included in the case series arrived at the referral hospital and had a good outcome.

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 of managing atonic postpartum haemorrhage with uterine balloon tamponade devices in public health settings of Maharashtra, India: an economic microcosting study

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 measured. This included cost of medical treatment, UBT intervention and PPH related surgeries undertaken in public health system of Maharashtra for year 2017–2018.ResultsMedical management of atonic PPH cost the health system US$37 (95% CI 29 to 45) per case, increasing to US$44 (95% CI 36 to 53) with condom-UBT and surgical interventions for uncontrolled cases. Similar cost was estimated for ESM-UBT. Bakri-UBT reported a higher cost of US$59 (95% CI 46 to 73) per case. Overall annual cost of managing 27 915 atonic PPH cases with condom-UBT intervention in Maharashtra was US$1 226 610 (95% CI 870 250 to 1 581 596).ConclusionsAtonic PPH management in public health facilities of Maharashtra with condom-UBT, ESM-UBT or Bakri-UBT accounts to 3.8%, 3.8% or 5.2% of the state’s annual spending on reproductive and child health services. These findings can guide policy-makers to include PPH complication management in publicly financed health schemes. Economic evaluation studies can use this evidence to determine cost effectiveness of UBT in Indian settings.

Postpartum infection, pain and experiences with care among women treated for postpartum hemorrhage in three African countries: A cohort study of women managed with and without condom-catheter uterine balloon tamponade

Objective We aimed to determine the risk of postpartum infection and increased pain associated with use of condom-catheter uterine balloon tamponade (UBT) among women diagnosed with postpartum hemorrhage (PPH) in three low- and middle-income countries (LMICs). We also sought women’s opinions on their overall experience of PPH care. Methods This prospective cohort study compared women diagnosed with PPH who received and did not receive UBT (UBT group and no-UBT group, respectively) at 18 secondary level hospitals in Uganda, Egypt, and Senegal that participated in a stepped wedge, cluster-randomized trial assessing UBT introduction. Key outcomes were reported pain (on a scale 0–10) in the immediate postpartum period and receipt of antibiotics within four weeks postpartum (a proxy for postpartum infection). Outcomes related to satisfaction with care and aspects women liked most and least about PPH care were also reported. Results Among women diagnosed with PPH, 58 were in the UBT group and 2188 in the no-UBT group. Self-reported, post-discharge antibiotic use within four weeks postpartum was similar in the UBT (3/58, 5.6%) and no-UBT groups (100/2188, 4.6%, risk ratio = 1.22, 95% confidence interval [CI]: 0.45–3.35). A high postpartum pain score of 8–10 was more common among women in the UBT group (17/46, 37.0%) than in the no-UBT group (360/1805, 19.9%, relative risk ratio = 3.64, 95% CI:1.30–10.16). Most women were satisfied with their care (1935/2325, 83.2%). When asked what they liked least about care, the most common responses were that medications (580/1511, 38.4%) and medical supplies (503/1511, 33.3%) were unavailable. Conclusion UBT did not increase the risk of postpartum infection among this population. Women who receive UBT may experience higher degrees of pain compared to women who do not receive UBT. Women’s satisfaction with their care and stockouts of medications and other supplies deserve greater attention when introducing new technologies like UBT.