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Efficacy and Feasibility of Chhattisgarh Balloon and Conventional Condom Balloon Tamponade: A 2-Year Prospective Study.

ABSTRACT: 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.

SUBMITTER: Mishra N

PROVIDER: S-EPMC6801252 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Efficacy and Feasibility of Chhattisgarh Balloon and Conventional Condom Balloon Tamponade: A 2-Year Prospective Study.

Mishra Nalini N Gulabani Kanchan K Agrawal Sumi S Shrivastava Chandrashekhar C

Journal of obstetrics and gynaecology of India 20190105 Suppl 2

<h4>Objective</h4>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).<h4>Materials and methods</h4>The present non-randomised prospective case series was carried out from Decembe ...[more]

PMID: 31686746

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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.

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.

Project description:BACKGROUND:Physical rehabilitation is recommended after total knee arthroplasty (TKA). With the expected increase in TKA over the next few decades, it is important to find new ways of delivering cost-effective interventions. Technological interventions have been developed with this intent, but only preliminary evidence exists regarding their validity, with short follow-up times. OBJECTIVE:This study aimed to present the follow-up results of a feasibility study comparing two different home-based programs after TKA: conventional face-to-face sessions and a digital intervention performed through the use of an artificial intelligence-powered biofeedback system under remote clinical monitoring. METHODS:The digital intervention uses a motion tracker allowing 3D movement quantification, a mobile app and a Web portal. This study presents the results of the previous single-center, prospective, parallel-group, feasibility study including an 8-week active treatment stage and further assessments at 3 and 6 months post-TKA. Primary outcome was the Timed Up and Go score, and secondary outcomes were the Knee Osteoarthritis Outcome Scale (KOOS) score and knee range of motion. RESULTS:A total of 59 patients completed the study (30 in the digital intervention group and 29 in the conventional rehabilitation group) and follow-up assessments. During the active treatment stage, patients in the digital intervention group demonstrated high engagement and satisfaction levels, with an 82% retention rate. Both groups attained clinically relevant improvements from baseline to 6 months post-TKA. At the end of the 8-week program, clinical outcomes were superior in the digital intervention group. At the 3- and 6-month assessments, the outcomes remained superior for the Timed Up and Go score (P<.001) and all KOOS subscale scores (at 3 months, P<.001 overall; at 6 months, KOOS Symptoms: P=.006, Pain: P=.002, Activities of Daily Living: P=.001, Sports: P=.003, and Quality of Life: P=.001). There was progressive convergence between both groups in terms of the knee range of motion, which remained higher for standing flexion in the digital intervention group than the conventional group at 6 months (P=.01). For the primary outcome, at 6 months, the median difference between groups was 4.87 seconds (95% CI 1.85-7.47), in favor of the digital intervention group. CONCLUSIONS:The present study demonstrates that this novel digital intervention for independent home-based rehabilitation after TKA is feasible, engaging, and capable of maximizing clinical outcomes in comparison to conventional rehabilitation in the short and medium term; in addition, this intervention is far less demanding in terms of human resources. TRIAL REGISTRATION:ClinicalTrials.gov NCT03047252; https://clinicaltrials.gov/ct2/show/NCT03047252.

Project description:ObjectiveTo carry out a prospective two year follow up study comparing conventional radiography, three-phase bone scintigraphy, ultrasonography (US), and three dimensional (3D) magnetic resonance imaging (MRI) with precontrast and dynamic postcontrast examination in detecting early arthritis. The aim of the follow up study was to monitor the course of erosions during treatment with disease modifying antirheumatic drugs by different modalities and to determine whether the radiographically occult changes like erosive bone lesions of the finger joints detected by MRI and US in the initial study would show up on conventional radiographs two years later. Additionally, to study the course of soft tissue lesions depicted in the initial study in comparison with the clinical findings.MethodsThe metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints (14 joints) of the clinically more severely affected hand (soft tissue swelling and joint tenderness) as determined in the initial study of 49 patients with various forms of arthritis were examined twice. The patients had initially been divided into two groups. The follow up group I included 28 subjects (392 joints) without radiographic signs of destructive arthritis (Larsen grades 0-1) of the investigated hand and wrist, and group II (control group) included 21 patients (294 joints) with radiographs showing erosions (Larsen grade 2) of the investigated hand or wrist, or both, at the initial examination.Results(1) Radiography at the two year follow up detected only two erosions (two patients) in group I and 10 (nine patients) additional erosions in group II. Initial MRI had already detected both erosions in group I and seven (seven patients) of the 10 erosions in group II. Initial US had depicted one erosion in group I and four of the 10 erosions in group II. (2) In contrast with conventional radiography, 3D MRI and US demonstrated an increase in erosions in comparison with the initial investigation. (3) The abnormal findings detected by scintigraphy were decreased at the two year follow up. (4) Both groups showed a marked clinical improvement of synovitis and tenosynovitis, as also shown by MRI and US. (5) There was a striking discrepancy between the decrease in the soft tissue lesions as demonstrated by clinical findings, MRI, and US, and the significant increase in erosive bone lesions, which were primarily evident at MRI and US.ConclusionsDespite clinical improvement and a regression of inflammatory soft tissue lesions, erosive bone lesions were increased at the two year follow up, which were more pronounced with 3D MRI and less pronounced with US. The results of our study suggest that owing to the inadequate depiction of erosions and soft tissue lesions, conventional radiography alone has limitations in the intermediate term follow up of treatment. US has a high sensitivity for depicting inflammatory soft tissue lesions, but dynamic 3D MRI is more sensitive in differentiating minute erosions.

Dataset Information

Efficacy and Feasibility of Chhattisgarh Balloon and Conventional Condom Balloon Tamponade: A 2-Year Prospective Study.

Publications

Efficacy and Feasibility of Chhattisgarh Balloon and Conventional Condom Balloon Tamponade: A 2-Year Prospective Study.

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