scholarly journals A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial

2018 ◽  
Vol 22 (2) ◽  
pp. 1-88 ◽  
Author(s):  
Khalid S Khan ◽  
Philip Moore ◽  
Matthew Wilson ◽  
Richard Hooper ◽  
Shubha Allard ◽  
...  

BackgroundCaesarean section is associated with blood loss and maternal morbidity. Excessive blood loss requires transfusion of donor (allogeneic) blood, which is a finite resource. Cell salvage returns blood lost during surgery to the mother. It may avoid the need for donor blood transfusion, but reliable evidence of its effects is lacking.ObjectivesTo determine if routine use of cell salvage during caesarean section in mothers at risk of haemorrhage reduces the rates of blood transfusion and postpartum maternal morbidity, and is cost-effective, in comparison with standard practice without routine salvage use.DesignIndividually randomised controlled, multicentre trial with cost-effectiveness analysis. Treatment was not blinded.SettingA total of 26 UK obstetric units.ParticipantsOut of 3054 women recruited between June 2013 and April 2016, we randomly assigned 3028 women at risk of haemorrhage to cell salvage or routine care. Randomisation was stratified using random permuted blocks of variable sizes. Of these, 1672 had emergency and 1356 had elective caesareans. We excluded women for whom cell salvage or donor blood transfusion was contraindicated.InterventionsCell salvage (intervention) versus routine care without salvage (control). In the intervention group, salvage was set up in 95.6% of the women and, of these, 50.8% had salvaged blood returned. In the control group, 3.9% had salvage deployed.Main outcome measuresPrimary – donor blood transfusion. Secondary – units of donor blood transfused, time to mobilisation, length of hospitalisation, mean fall in haemoglobin, fetomaternal haemorrhage (FMH) measured by Kleihauer–Betke test, and maternal fatigue. Analyses were adjusted for stratification factors and other factors that were believed to be prognostic a priori. Cost-effectiveness outcomes – costs of resources and service provision taking the UK NHS perspective.ResultsWe analysed 1498 and 1492 participants in the intervention and control groups, respectively. Overall, the transfusion rate was 2.5% in the intervention group and 3.5% in the control group [adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42 to 1.01;p = 0.056]. In a planned subgroup analysis, the transfusion rate was 3.0% in the intervention group and 4.6% in the control group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 1.8% in the intervention group and 2.2% in the control group among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interactionp = 0.46, suggesting that the difference in effect between subgroups was not statistically significant). Secondary outcomes did not differ between groups, except for FMH, which was higher under salvage in rhesus D (RhD)-negative women with RhD-positive babies (25.6% vs. 10.5%, adjusted OR 5.63, 95% CI 1.43 to 22.14;p = 0.013). No case of amniotic fluid embolism was observed. The additional cost of routine cell salvage during caesarean was estimated, on average, at £8110 per donor blood transfusion avoided.ConclusionsThe modest evidence for an effect of routine use of cell salvage during caesarean section on rates of donor blood transfusion was associated with increased FMH, which emphasises the need for adherence to guidance on anti-D prophylaxis. We are unable to comment on long-term antibody sensitisation effects. Based on the findings of this trial, cell salvage is unlikely to be considered cost-effective.Future workResearch into risk of alloimmunisation among women exposed to cell salvage is needed.Trial registrationCurrent Controlled Trials ISRCTN66118656.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 2. See the NIHR Journals Library website for further project information.

2019 ◽  
Author(s):  
Yushan Ma ◽  
Xi Luo ◽  
Xuemei Lin ◽  
xiaoqin Jiang ◽  
Hui Liu ◽  
...  

Abstract Background Pernicious placenta previa (PPP) is the main cause of severe obstetric postpartum hemorrhage (PPH) and hysterectomy and often requires donor blood transfusion. Prophylactic internal iliac artery (IIA) balloon occlusion (BO) combined with cell salvage is increasingly being deployed in parallel transverse uterine incision (PTUI) cesarean section (CS). The aim of this study was to explore the differences in blood management in PTUI CS with or without prophylactic IIA BO and to evaluate the safety and efficacy of cell salvage to reduce the need for donor blood transfusion during PTUI CS. Methods This retrospective study included all women who were diagnosed with PPP and PA and underwent PTUI CS from October 1, 2016, to October 31, 2018. Sixty-four patients were included: 34 underwent prophylactic IIA BO (IIA group), while 30 were treated without prophylactic IIA BO (control group). The primary outcome was a composite measure of perioperative blood management outcomes, including the estimated blood loss (EBL), donor blood transfusion, salvaged blood returned, fresh frozen plasma (FFP), pre- and postoperative serum hemoglobin(Hb) and hematocrit (HCT). In addition, the baseline conditions of mother and neonates were compared. Results The EBL was significantly higher in the IIA group compared to the control group (2883.5 ML in the IIA group versus 1868.7 ML in the control group, P=0.001). Overall, the donor blood transfusion rate was 23.5% (8/34), averaging 4.2 U, in the IIA group versus 30% (9/30), averaging 3.4 U, in the control group, which were not significantly different. The FFP transfusion rate was 47%, averaging 765.6 ml, in the IIA group versus 20%, averaging 816.7 ml, in the control group. In the IIA group, 97.1% used cell savage and had salvaged blood returned, averaging 954.9 ml. In the control group, 90% had salvaged blood returned, averaging 617.9 ml. No cases of amniotic fluid embolism were observed with leukocyte depletion filters. Conclusion Prophylactic IIA BO during PTUI CS in women with PPP and PA does not lead to a statistically significant reduction in EBL. Cell salvage was associated with a reduction in the rate of donor blood transfusion during PTUI CS.


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e022352 ◽  
Author(s):  
Carol McLoughlin ◽  
Tracy E Roberts ◽  
Louise J Jackson ◽  
Philip Moore ◽  
Matthew Wilson ◽  
...  

ObjectivesTo evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care.DesignModel-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section.Setting26 obstetric units in the UK.Participants3028 women at risk of haemorrhage recruited between June 2013 and April 2016.InterventionsCell salvage (intervention) versus routine care without salvage (control).Primary outcome measuresCost-effectiveness based on incremental cost per donor blood transfusion avoided.ResultsIn the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses.ConclusionsThe results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies.Trial registration numberISRCTN66118656.


2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 119-120
Author(s):  
N. Østerås ◽  
E. Aas ◽  
T. Moseng ◽  
L. Van Bodegom-Vos ◽  
K. Dziedzic ◽  
...  

Background:To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international treatment recommendations. A previous analysis of a cluster RCT (cRCT) showed that compared to usual care, the intervention group reported higher quality of care and greater satisfaction with care. Also, more patients were treated according to international guidelines and fulfilled recommendations for physical activity at the 6-month follow-up.Objectives:To assess the cost-utility of a structured model for hip or knee OA care.Methods:A cRCT with stepped-wedge cohort design was conducted in 6 Norwegian municipalities (clusters) in 2015-17. The OA care model was implemented in one cluster at the time by switching from “usual care” to the structured model. The implementation of the model was facilitated by interactive workshops for general practitioners (GPs) and physiotherapists (PTs) with an update on OA treatment recommendations. The GPs explained the OA diagnosis and treatment alternatives, provided pharmacological treatment when appropriate, and suggested referral to physiotherapy. The PT-led patient OA education programme was group-based and lasted 3 hours followed by an 8–12-week individually tailored resistance exercise programme with twice weekly 1-hour supervised group sessions (5–10 patients per PT). An optional 10-hours Healthy Eating Program was available. Participants were ≥45 years with symptomatic hip or knee OA.Costs were measured from the healthcare perspective and collected from several sources. Patients self-reported visits in primary healthcare at 3, 6, 9 and 12 months. Secondary healthcare visits and joint surgery data were extracted from the Norwegian Patient Register. The health outcome, quality-adjusted life-year (QALY), was estimated based on the EQ-5D-5L scores at baseline, 3, 6, 9 and 12 months. The result of the cost-utility analysis was reported using the incremental cost-effectiveness ratio (ICER), defined as the incremental costs relative to incremental QALYs (QALYs gained). Based on Norwegian guidelines, the threshold is €27500. Sensitivity analyses were performed using bootstrapping to assess the robustness of reported results and presented in a cost-effectiveness plane (Figure 1).Results:The 393 patients’ mean age was 63 years (SD 9.6) and 74% were women. 109 patients were recruited during control periods (control group), and 284 patients were recruited during interventions periods (intervention group). Only the intervention group had a significant increase in EQ-5D-5L utility scores from baseline to 12 months follow-up (mean change 0.03; 95% CI 0.01, 0.05) with QALYs gained: 0.02 (95% CI -0.08, 0.12). The structured OA model cost approx. €301 p.p. with an additional €50 for the Healthy Eating Program. Total 12 months healthcare cost p.p. was €1281 in the intervention and €3147 in the control group, resulting in an incremental cost of -€1866 (95% CI -3147, -584) p.p. Costs related to surgical procedures had the largest impact on total healthcare costs in both groups. During the 12-months follow-up period, 5% (n=14) in the intervention compared to 12% (n=13) in the control group underwent joint surgery; resulting in a mean surgical procedure cost of €553 p.p. in the intervention as compared to €1624 p.p. in the control group. The ICER was -€93300, indicating that the OA care model resulted in QALYs gained and cost-savings. At a threshold of €27500, it is 99% likely that the OA care model is a cost-effective alternative.Conclusion:The results of the cost-utility analysis show that implementing a structured model for OA care in primary healthcare based on international guidelines is highly likely a cost-effective alternative compared to usual care for people with hip and knee OA. More studies are needed to confirm this finding, but this study results indicate that implementing structured OA care models in primary healthcare may be beneficial for the individual as well as for the society.Disclosure of Interests:None declared


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Pei Ern Mary Ng ◽  
Sean Olivia Nicholas ◽  
Shiou Liang Wee ◽  
Teng Yan Yau ◽  
Alvin Chan ◽  
...  

AbstractTo address the paucity of research investigating the implementation of multi-domain dementia prevention interventions, we implemented and evaluated a 24-week, bi-weekly multi-domain program for older adults at risk of cognitive impairment at neighborhood senior centres (SCs). It comprised dual-task exercises, cognitive training, and mobile application-based nutritional guidance. An RCT design informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance framework was adopted. Outcome measures include cognition, quality of life, blood parameters, and physical performance. Implementation was evaluated through questionnaires administered to participants, implementers, SC managers, attendance lists, and observations. The program reached almost 50% of eligible participants, had an attrition rate of 22%, and was adopted by 8.7% of the SCs approached. It was implemented as intended; only the nutritional component was re-designed due to participants’ unfamiliarity with the mobile application. While there were no between-group differences in cognition, quality of life, and blood parameters, quality of life reduced in the control group and physical function improved in the intervention group after 24 weeks. The program was well-received by participants and SCs. Our findings show that a multi-domain program for at-risk older adults has benefits and can be implemented through neighborhood SCs. Areas of improvement are discussed.Trial registration: ClinicalTrials.gov NCT04440969 retrospectively registered on 22 June 2020.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.


Author(s):  
Zahra Moudi ◽  
Behjat Talebi ◽  
Mahnaz Shahraki Pour

Abstract Background Annually, about 16 million adolescent girls give birth, accounting for 11% of all births worldwide. Ninety-five percent of these births occur in low- and middle-income countries, and previous studies have addressed the need for parenting interventions in developing countries with limited health care resources to improve parenting behaviors. Objective To explore the effect of a brief training program for primigravid adolescents on parenting self-efficacy and mother-infant bonding. Subjects We enrolled 116 married pregnant adolescents. Methods This quasi-experimental study was conducted during August 22, 2016–February 3, 2017. The intervention group received three sessions of training on neonatal care, while the control group received the routine care. We evaluated parenting self-efficacy using the Perceived Maternal Parenting Self-Efficacy (PMP S-E) questionnaire, the mother-infant bonding using the Postpartum Bonding Questionnaire (PBQ) and social support by means of the Multidimensional Scale of Perceived Social Support (MSPSS). The participants were followed up for 1 month. Results The mean ages of the intervention and the control groups were 16.37 ± 0.97 and 16.27 ± 1.12 years, respectively. The intervention group obtained higher self-efficacy and bonding scores compared to the control group. The logistic regression model showed that the second (evoking behaviors) and the third (reading behavior or signaling) subscales of the PMP S-E, the route of delivery and women’s educational levels could predict the mother-infant bonding scores. Conclusion Primigravid adolescents can benefit from brief interventions during pregnancy through improving their parenting self-efficacy and mother-infant bonding.


2019 ◽  
Vol 9 (2) ◽  
pp. 82-87 ◽  
Author(s):  
Nicole M. Daniel ◽  
Kim Walsh ◽  
Henry Leach ◽  
Lauren Stummer

Abstract Introduction Many medications commonly prescribed in psychiatric hospitals can cause QTc-interval prolongation, increasing a patient's risk for torsades de pointes and sudden cardiac death. There is little guidance in the literature to determine when an electrocardiogram (ECG) and QTc-interval monitoring should be performed. The primary end point was improvement of the appropriateness of ECGs and QTc-interval monitoring of at-risk psychiatric inpatients at Barnabas Health Behavioral Health Center (BHBH) and Monmouth Medical Center (MMC) following implementation of a standardized monitoring protocol. The secondary end point was the number of pharmacist-specific interventions at site BHBH only. Methods Patients who met the inclusion criteria were assessed using a standardized QTc-prolongation assessment algorithm for ECG appropriateness. A retrospective analysis of a control group (no protocol) from January 1, 2016, to July 17, 2017, was compared with a prospective analysis of the intervention group (with protocol) from December 11, 2017, to March 11, 2018. Results At BHBH, appropriate ECG utilization increased 25.5% after implementation of a standardized protocol (P = .0172) and appropriate omission of ECG utilization improved by 26% (P < .00001). At MMC, appropriate ECGs decreased by 5%, and appropriate ECG omissions increased by 28%, neither of which were statistically significant (P = 1.0 and P = .3142, respectively). There was an increase in overall pharmacist monitoring. Discussion The study demonstrated that pharmacist involvement in ECG and QTc-interval monitoring utilizing a uniform protocol may improve the appropriateness of ECG and QTc-interval monitoring in patients in an acute care inpatient psychiatric hospital.


2019 ◽  
Vol 64 (2) ◽  
pp. 222-233
Author(s):  
I. A. Pashkova

Introduction. Screening and identification of anti-erythrocyte alloimmune antibodies in recipients is an important and necessary step in their testing before blood transfusion.Aim. To formulate algorithms that could facilitate the process of pre-transfusion immunohematological testing.General findings. Such a testing allows the development of post-transfusion reactions and complications to be avoided. The presence of alloantibodies of various specificities and autoantibodies in the test blood may complicate pre-transfusion testing and require the use of additional methods (adsorption, elution, etc.). The author has proposed an effective system of algorithms for conducting immunohematological studies, which can be used to identify patients at risk of developing immune post-transfusion complications and ensure an individual selection of compatible donor blood-transfusion products.


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