Bakri balloon tamponade to treat postpartum hemorrhage.
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ABSTRACT:
SUBMITTER: Yang H
PROVIDER: S-EPMC9771167 | biostudies-literature | 2022 Sep
REPOSITORIES: biostudies-literature
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Bakri balloon tamponade to treat postpartum hemorrhage.
Yang Hui H Sun Guoqiang G Cheng Yao Y Cao Dongmei D Zhao Yun Y
Chinese medical journal 20220920 18
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Project description:ObjectiveTo identify the predictors of intrauterine balloon tamponade (IUBT) failure for persistent postpartum hemorrhage (PPH) after vaginal delivery.DesignRetrospective case-series in five maternity units in a perinatal network.SettingAll women who underwent IUBT for persistent PPH after vaginal delivery from January 2011 to December 2015 in these hospitals.MethodsAll maternity apply the same management policy for PPH. IUBT, using a Bakri balloon, was used as a second line therapy for persistent PPH after failure of bimanual uterine massage and uterotonics to stop bleeding after vaginal delivery. Women who required another second line therapy (embolization or surgical procedures) to stop bleeding after IUBT were defined as cases, and women whom IUBT stopped bleeding were defined as control group. We determined independent predictors for failed IUBT using multiple regression and adjusting for demographics with adjusted odds ratios (aORs) and 95% confidence intervals (95% CI).ResultsDuring the study period, there were 91,880 deliveries in the five hospitals and IUBT was used in 108 women to control bleeding. The success rate was 74.1% (80/108). In 28 women, invasive procedures were required (19 embolization and 9 surgical procedures with 5 peripartum hysterectomies). Women with failed IUBT were more often obese (25.9% vs. 8.1%; p = 0.03), duration of labor was shorter (363.9 min vs. 549.7min; p = 0.04), and major PPH (?1,500 mL) before IUBT was more frequent (64% vs. 40%; p = 0.04). Obesity was a predictive factor of failed IUBT (aOR 4.40, 95% CI 1.06-18.31). Major PPH before IUBT seemed to be another predictor of failure (aOR 1.001, 95% CI 1.000-1.002), but our result did not reach statistical significativity.ConclusionIntrauterine balloon tamponade is an effective second line therapy for persistent primary PPH after vaginal delivery. Pre-pregnancy obesity is a risk factor of IUBT failure.
| S-EPMC6203390 | biostudies-literature
Project description:BackgroundThe use of intrauterine balloon tamponade to manage postpartum hemorrhage is increasing. However, there is lack of studies on the menstrual and reproductive outcomes after such treatment. The purpose of this study is to explore the menstrual and reproductive outcomes for patients who had been managed by intrauterine balloon tamponade for severe postpartum hemorrhage in her index pregnancy.MethodsAll patients who had delivered in United Christian Hospital from January 2011 to June 2016 with severe postpartum hemorrhage (PPH) (blood loss> = 1 L) were identified by the labour ward delivery registry and a comprehensive obstetric database. Patients who had intrauterine balloon tamponade inserted were compared with those managed solely by uterotonic agents as controls. Patients who had hysterectomy or additional procedures performed, such as compression sutures or uterine artery embolization were excluded from both groups. A questionnaire on menses, fertility and reproductive outcomes was mailed to both groups of patients. Those that had not replied within 4 weeks would receive a telephone survey.ResultsA total of 39 patients in the balloon tamponade group and 161 patients in the control group were recruited, which represented 87.0% of all eligible patients within the study period. The median follow up period was 45 months. All patients in the balloon tamponade group had return of menses after delivery. The majority of the patients (87.2%) in the balloon tamponade group had normal menstrual patterns in the 12 months after the index delivery as well as in the most recent 12 months. After excluding the patients with contraception, the subsequent pregnancy rate was 42.9% (9/21) in the balloon tamponade group compared to 45.9% (28/61) in the control group (p = 0.81). Among the 9 subsequent pregnancies in the balloon tamponade group, there were two miscarriages, one scar pregnancy, one induced abortion, while the remaining five were normal pregnancies with full term deliveries without intrauterine growth restriction. The majority of patients replied that they were satisfied with using Bakri balloon for PPH management in their index pregnancy.ConclusionsIntrauterine balloon tamponade for the management of severe PPH appeared to pose little adverse effects on subsequent menstrual and reproductive function.
| S-EPMC6249747 | 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: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: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:BackgroundUterine tamponade is widely promoted for treating refractory postpartum hemorrhage (PPH); however, its cost-effectiveness may vary depending on unit costs and setting.ObjectiveTo review available data on cost-effectiveness of uterine tamponade devices when used for PPH treatment.Search strategyPubMed and EMBASE were searched (1980 to January 2020), as well as the National Health Services Economic Evaluation database from inception (1995) to March 2015.Selection criteriaEligible studies were any type of economic evaluation, or effectiveness studies that provided cost or economic data.Data collection and analysisTwo reviewers independently screened studies, extracted data, and assessed quality.Main resultsEleven studies using a range of devices (condom catheter, uterine suction devices, Bakri, Inpress, Ellavi) were identified. Cost of condom catheter devices or kits ranged from US$0.64 to US$6, whereas purpose-designed device costs were up to US$400. Two studies that took a health system perspective assessed the cost-effectiveness of using uterine balloon tamponade and suggested that it was highly cost-effective because of the low cost per disability-adjusted life-year averted, although both used effect estimates from case series.ConclusionsEvidence on the cost-effectiveness of uterine tamponade devices was limited and not generalizable. Rigorous economic evaluations based on updated effect estimates are needed.
| S-EPMC7756424 | 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:Placenta previa and placenta accreta carry significant maternal and fetal morbidity and mortality. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections. The objective of this study was to evaluate the efficacy and safety of the use of the cervix as a natural tamponade in controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.This prospective study was conducted on 40 pregnant women admitted to our hospital between June 2012 and November 2014. All participating women had one or more previous cesarean deliveries and were diagnosed with placenta previa and/or placenta previa accreta. Significant bleeding from the placental bed during cesarean section was managed by inverting the cervix into the uterine cavity and suturing the anterior and/or the posterior cervical lips into the anterior and/or posterior walls of the lower uterine segment.The technique of cervical inversion described above was successful in stopping the bleeding in 38 out of 40 patients; yielding a success rate of 95%. We resorted to hysterectomy in only two cases (5%). The mean intra-operative blood loss was 1572.5 mL, and the mean number of blood units transfused was 3.1. The mean time needed to perform the technique was 5.4?±?0.6 min. The complications encountered were as follows: bladder injury in the two patients who underwent hysterectomy and wound infection in one patient. Postoperative fever that responded to antibiotics occurred in 1 patient. The mean duration of the postoperative hospital stay was 3.5 daysThis technique of using the cervix as a natural tamponade appears to be safe, simple, time-saving and potentially effective method for controlling the severe postpartum hemorrhage (PPH) caused by placenta previa/placenta previa accreta. This technique deserves to be one of the tools in the hands of obstetricians who face the life-threatening hemorrhage of placenta accreta.ClinicalTrials.gov NCT02590484 . Registered 28 October 2015.
| S-EPMC4642648 | biostudies-literature
Project description:ObjectiveTo assess the effectiveness of low-cost uterine tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings.DesignRandomised controlled trial.SettingSeven healthcare facilities in Cotonou, Benin and Bamako, Mali.PopulationWomen delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics.MethodsWomen were randomly assigned to receive uterine balloon tamponade with a condom-catheter device or no tamponade; both groups were also given intrarectal or sublingual misoprostol.Main outcome measureProportion of women with invasive surgery or who died before hospital discharge.ResultsThe proportion of primary composite outcome did not differ significantly between the tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059).Trial registration numberISRCT Registry Number 01202389; Post-results.
| S-EPMC5589006 | biostudies-literature
Project description:Objective:To 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 Methods:The 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. Results:CGB 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. Conclusion:CGB 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