Easy Balloon: The Easiest to Assemble Condom Balloon Uterine Tamponade for Primary Level of Health Care Centres.
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ABSTRACT:
SUBMITTER: Mishra N
PROVIDER: S-EPMC5561755 | biostudies-literature | 2017 Oct
REPOSITORIES: biostudies-literature
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Easy Balloon: The Easiest to Assemble Condom Balloon Uterine Tamponade for Primary Level of Health Care Centres.
Mishra Nalini N Shrivastava Chandrashekhar C Agrawal Sumi S Mahilange Anchala A Sai M Mamta MM Gulabani Kanchan K
Journal of obstetrics and gynaecology of India 20170606 5
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Project description:ObjectiveTo evaluate the clinical efficacy of two types of condom uterine balloon tamponade systems, namely Chhattisgarh condom balloon device "CG balloon (CGB)" having a central drainage channel as well as indigenous tying system to fasten condom to the catheter and conventional condom uterine balloon device (C-UBT) as a second-line intervention in post-partum haemorrhage (PPH).Materials and methodsThe present non-randomised prospective case series was carried out from December 2014 to September 2016 and included 60 women having PPH which was refractory to first-line management and who were treated with either of the two condom balloon tamponade devices prepared on spot. Women with allergy to latex, retained placenta, uterine rupture, anomaly, genital infection and/or malignancy were excluded. Case report forms were filled for all participants and analysed. Primary outcome was arrest of haemorrhage, and one of the secondary outcomes was cost and consistency of the devices.ResultsCGB was used in 46 and C-UBT in 14 women. The overall success rate was 98.33%. The mean blood loss was 1417 mL. Women of C-UBT group had greater blood loss, higher inflation volume and delays due to technical issues (OR 7.6). CGB was cheaper and more consistent than C-UBT by omitting the use of suture material.ConclusionCGB and conventional condom balloon tamponade both are easy to use, feasible and efficacious for control of PPH, but CGB condom balloon device has the advantage of a central drainage lumen for real-time assessment of blood loss and therefore early corrective action.
| S-EPMC6801252 | biostudies-literature
Project description:ObjectiveTo assess the effectiveness of introducing condom-catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low- and middle-income settings.DesignStepped wedge, cluster-randomised trial.SettingEighteen secondary-level hospitals in Uganda, Egypt and Senegal.PopulationWomen with vaginal delivery from October 2016 to March 2018.MethodsUse of condom-catheter UBT for PPH management was introduced using a half-day training and provision of pre-packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect).Main outcome measuresCombined IR of PPH-related invasive surgery and/or maternal death.ResultsThere were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH-related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07-15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods.ConclusionsIntroduction of condom-catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH-related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role.Tweetable abstractStepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH-related surgery or death.
| S-EPMC6899652 | biostudies-literature
Project description:ObjectiveWe 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.MethodsThis 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.ResultsAmong 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.ConclusionUBT 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.
| S-EPMC7869979 | biostudies-literature
Project description:ObjectiveContrast-enhanced ultrasonography (CEU) has been used in critical trauma situations to visualize extravasation; however, its use is limited in the field of obstetrics. Cases of ruptured uterine artery pseudoaneurysm (UAP) were analyzed to clarify the efficacy to CEU during uterine balloon tamponade.MethodsCases of ruptured UAP diagnosed at a teaching university hospital from January 2015 to December 2017 were retrospectively analyzed. UAP was diagnosed using color Doppler ultrasonography. Extravasation was identified using computed tomography and double checked using CEU with an intravenously administered contrast agent (Sonazoid; Daiichi Sankyo Company, Ltd., Tokyo, Japan) and an ultrasound instrument (HI VISION Preirus; Hitachi Aloka Medical, Ltd., Tokyo, Japan). A balloon was then inserted into the uterine cavity and inflated at the point of bleeding until extravasation ceased.ResultsThree patients exhibited ruptured UAP during the study period. Bleeding points were successfully identified using CEU in all cases, and hemostasis was achieved using uterine balloon tamponade. Obliteration of UAP was confirmed using magnetic resonance imaging, and no patients developed recurrent UAP or any complications.ConclusionCEU can be used at the bedside to promptly diagnose ruptured UAP. Moreover, it precisely facilitates balloon compression at the point of bleeding.
| S-EPMC7645375 | biostudies-literature
Project description:ObjectiveTo understand healthcare providers' experiences with improvised uterine balloon tamponade (UBT) for the management of uncontrolled postpartum hemorrhage (PPH).MethodsIn a qualitative descriptive study, in-depth semi-structured interviews were conducted between November 2014 and June 2015 among Kenyan healthcare providers who had previous experience with improvising a UBT device. Interviews were conducted, audio-recorded, and transcribed.ResultsOverall, 29 healthcare providers (14 nurse-midwifes, 7 medical officers, 7 obstetricians, and 1 clinical officer) were interviewed. Providers perceived improvised UBT as valuable for managing uncontrolled PPH. Reported benefits included effectiveness in arresting hemorrhage and averting hysterectomy, and ease of use by providers of all levels of training. Providers used various materials to construct an improvised UBT. Challenges to improvising UBT-e.g. searching for materials during an emergency, procuring male condoms, and inserting fluid via a small syringe-were reported to lead to delays in care. Providers described their introduction to improvised UBT through both formal and informal sources. There was universal enthusiasm for widespread standardized training.ConclusionImprovised UBT seems to be a valuable second-line treatment for uncontrolled PPH that can be used by providers of all levels. UBT might be optimized by integrating a standard package across the health system.
| S-EPMC5073071 | biostudies-literature
Project description: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.
| S-EPMC7795364 | biostudies-literature
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.
| S-EPMC8372914 | biostudies-literature
Project description: Not available
| S-EPMC9771167 | biostudies-literature
Project description: Not available
| S-EPMC6899763 | biostudies-literature
Project description: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.
| S-EPMC7929829 | biostudies-literature