Dataset Information

Efficacy of Intra-Uterine Tamponade Balloon in Post-Partum Hemorrhage after Cesarean Delivery: An Impact Study.

ABSTRACT: Invasive therapies (surgery or radiological embolization) are used to control severe post-partum hemorrhage. The intra-uterine tamponade balloon is a potential alternative, well documented after vaginal delivery. However, available data on its use after cesarean delivery remain scarce. This study assessed the efficacy of the intra-uterine tamponade balloon during post-partum hemorrhage in a cesarean delivery setting. Using a retrospective impact design, post-partum hemorrhage-related outcomes before ("pre-balloon" period) versus after implementation of intra-uterine tamponade balloon ("post-balloon" period) were compared. All women with post-partum hemorrhage requiring potent uterotonic treatment with prostaglandins after cesarean delivery over a 9-year period were eligible. The primary outcome was the rate of invasive procedure (conservative surgery, radiological embolization and/or hysterectomy). p < 0.05 was considered statistically significant. A total of 279 patients were included (140 vs. 139). Most baseline characteristics were comparable between the two studied periods. The success rate of the intra-uterine tamponade balloon was 82%, and no related complications occurred. Rates of invasive procedures and transfusion were significantly reduced (28.6% vs. 11.5%, p < 0.001 and 44.3% vs. 28.1%, p = 0.006 respectively) during the "post-balloon" period, and length of hospital stay was shorter (p < 0.001). Implementation of intra-uterine tamponade balloon during post-partum hemorrhage after cesarean delivery appears to be safe and effective, with a decrease in both invasive procedures and transfusion rates.

SUBMITTER: Soued M

PROVIDER: S-EPMC7795364 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Efficacy of Intra-Uterine Tamponade Balloon in Post-Partum Hemorrhage after Cesarean Delivery: An Impact Study.

Soued Mickaël M Vivanti Alexandre J AJ Smiljkovski Daniel D Deffieux Xavier X Benachi Alexandra A Le Gouez Agnès A Mercier Frédéric J FJ

Journal of clinical medicine 20201228 1

Invasive therapies (surgery or radiological embolization) are used to control severe post-partum hemorrhage. The intra-uterine tamponade balloon is a potential alternative, well documented after vaginal delivery. However, available data on its use after cesarean delivery remain scarce. This study assessed the efficacy of the intra-uterine tamponade balloon during post-partum hemorrhage in a cesarean delivery setting. Using a retrospective impact design, post-partum hemorrhage-related outcomes be ...[more]

PMID: 33379355

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Project description:ObjectivePost-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.MethodsA 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.ResultsESM-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.ConclusionFor 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.

Project description:BackgroundPostpartum 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.MethodsUsing 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.ResultsOut 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.ConclusionsProviders 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.

Project description:BackgroundFew studies have systematically addressed the role of epidural analgesia and caesarean delivery in predicting the post-partum disease activity in women with Multiple Sclerosis (MS).The objective of this study was to assess the impact of epidural analgesia (EA) and caesarean delivery (CD) on the risk of post-partum relapses and disability in women with MS.MethodsIn the context of an Italian prospective study on the safety of immunomodulators in pregnancy, we included pregnancies occurred between 2002 and 2008 in women with MS regularly followed-up in 21 Italian MS centers. Data were gathered through a standardized, semi-structured interview, dealing with pregnancy outcomes, breastfeeding, type of delivery (vaginal or caesarean) and EA. The risk of post-partum relapses and disability progression (1 point on the Expanded Disability Status Sclae, EDSS, point, confirmed after six months) was assessed through a logistic multivariate regression analysis.ResultsWe collected data on 423 pregnancies in 415 women. Among these, 349 pregnancies resulted in full term deliveries, with a post-partum follow-up of at least one year (mean follow-up period 5.5±3.1 years). One hundred and fifty-five patients (44.4%) underwent CD and 65 (18.5%) EA. In the multivariate analysis neither CD, nor EA were associated with a higher risk of post-partum relapses. Post-partum relapses were related to a higher EDSS score at conception (OR=1.42; 95% CI 1.11-1.82; p=0.005), a higher number of relapses in the year before pregnancy (OR=1.62; 95% CI 1.15-2.29; p=0.006) and during pregnancy (OR=3.07; 95% CI 1.40-6.72; p=0.005). Likewise, CD and EA were not associated with disability progression on the EDSS after delivery. The only significant predictor of disability progression was the occurrence of relapses in the year after delivery (disability progression in the year after delivery: OR= 4.00; 95% CI 2.0-8.2; p<0.001; disability progression over the whole follow-up period: OR= 2.0; 95% CI 1.2-3.3; p=0.005).ConclusionsOur findings, show no correlation between EA, CD and postpartum relapses and disability. Therefore these procedures can safely be applied in MS patients. On the other hand, post-partum relapses are significantly associated with increased disability, which calls for the need of preventive therapies after delivery.

Dataset Information

Efficacy of Intra-Uterine Tamponade Balloon in Post-Partum Hemorrhage after Cesarean Delivery: An Impact Study.

Publications

Efficacy of Intra-Uterine Tamponade Balloon in Post-Partum Hemorrhage after Cesarean Delivery: An Impact Study.

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