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Validation of three models for prediction of blood transfusion during cesarean delivery admission
Bruno, A., Federspiel, J. J., McGee, P., Pacheco, L., Saade, G., Parry, S., Longo, M., Tita, A., Gyamfi-Bannerman, C., Chauhan, S., et al
American journal of perinatology. 2023
Abstract
OBJECTIVE Prediction of blood transfusion during delivery admission allows for clinical preparedness and risk mitigation. Although prediction models have been developed and adopted into practice, their external validation is limited. We aimed to evaluate the performance of three blood transfusion prediction models in a U.S. cohort of individuals undergoing cesarean delivery. METHODS This was a secondary analysis of a multicenter randomized trial of tranexamic acid for prevention of hemorrhage at time of cesarean delivery. Three models were considered: a categorical risk tool (California Maternal Quality Care Collaborative (CMQCC)), and two regression models (Ahmadzia et al and Albright et al). The primary outcome was red blood cell transfusion. The CMQCC algorithm was applied to the cohort with frequency of risk category (low, medium, high) and associated transfusion rates reported. For the regression models, the area under the receiver-operating curve (AUC) was calculated and a calibration curve plotted to evaluate each model's capacity to predict receipt of transfusion. The regression model outputs were statistically compared. RESULTS Of 10,785 analyzed individuals, 3.9% received a red blood cell transfusion during delivery admission. The CMQCC risk tool categorized 1,970 (18.3%) individuals as low-risk, 5,259 (48.8%) as medium-risk, and 3,556 (33.0%) as high-risk with corresponding transfusion rates of 2.1% (95% CI 1.5-2.9%), 2.2% (95% CI 1.8-2.6%), and 7.5% (95% CI 6.6-8.4%), respectively. The AUC for prediction of blood transfusion using the Ahmadzia and Albright models was 0.78 (95% CI 0.76-0.81) and 0.79 (95% CI 0.77-0.82), respectively (p=0.38 for difference). Calibration curves demonstrated overall agreement between the predicted probability and observed likelihood of blood transfusion. CONCLUSION Three models were externally validated for prediction of blood transfusion during cesarean delivery admission in this U.S. COHORT Overall, performance was moderate; model selection should be based on ease of application until a specific model with superior predictive ability is developed.
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Comparison of quantitative and calculated postpartum blood loss after vaginal delivery
Madar, H., Sentilhes, L., Goffinet, F., Bonnet, M. P., Rozenberg, P., Deneux-Tharaux, C.
American journal of obstetrics & gynecology MFM. 2023;:101065
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Editor's Choice
Abstract
BACKGROUND Because there is no consensual method of assessing postpartum blood loss, the comparability and relevance of the postpartum hemorrhage-related literature is questionable. Quantitative blood loss assessment using a volumetric technique with a graduated collector bag has been proposed to overcome limitations of intervention-based outcomes but remains partly subjective and potentially biased by amniotic fluid or missed out-of-bag losses. Calculated blood loss based on laboratory parameters has been published and used as an objective method expected to reflect total blood loss, but few studies have compared quantitative with calculated blood loss. OBJECTIVE This study aimed to compare the distribution of postpartum blood loss after vaginal delivery assessed by two methods - quantitative and calculated blood loss - and the incidence of abnormal blood loss with each method. STUDY DESIGN The data came from the merged database of 3 multicenter, randomized controlled trials, all testing different interventions to prevent postpartum blood loss in individuals with a singleton live fetus ≥ 35 weeks, born vaginally. All 3 trials measured blood loss volume by using a graduated collector bag. Hematocrit was measured in the eighth or ninth month of gestation and on day 2 postpartum. The two primary outcomes were: quantitative blood loss defined by the total volume of blood loss measured in a graduated collector bag, and calculated blood loss mathematically defined from the peripartum hematocrit change (estimated blood volume × [(antepartum hematocrit - postpartum hematocrit)/antepartum hematocrit], where estimated blood volume (mL) = booking weight (kg) × 85). We modelled the association between positive quantitative blood loss and positive calculated blood loss with polynomial regression and calculated the Spearman correlation coefficient. RESULTS Among the 8341 individuals included in this analysis, the median quantitative blood loss (100 mL, interquartile range 50-275) was significantly lower than the median calculated blood loss (260 mL, interquartile range 0-630) (P<.05). The incidence of abnormal blood loss was lower with quantitative blood loss than calculated blood loss for blood loss ≥ 500 mL, ≥ 1000 mL and ≥ 2000 mL, respectively, it was 9.6% (799/8341) vs 32.3% (2691/8341), 2.1% (176/8341) vs 11.5% (959/8341), and 0.1% (10/8341) vs 1.4% (117/8341); (P<.05). Quantitative blood loss and calculated blood loss were significantly but moderately correlated (Spearman coefficient=0.44; P<.05). The association between them was not linear, and their difference tended to increase with blood loss. Negative calculated blood loss values occurred in 23% (1958/8341) of individuals; among them, more than 99% (1939/1958) had quantitative blood loss ≤ 500 mL. CONCLUSION Quantitative and calculated blood loss were significantly but moderately correlated after vaginal delivery. However, clinicians should be aware that quantitative blood loss is lower than calculated blood loss, with a difference that tended to rise as blood loss increased.
PICO Summary
Population
Patients who gave birth vaginally, participating in the TRACOR, CYTOCINON, and TRAAP randomised controlled trials (RCTs) in several French maternity units (n= 8,341).
Intervention
This study aimed to compare the distribution of postpartum blood assessed by two methods - quantitative and calculated blood loss - and the incidence of abnormal blood loss with each method.
Comparison
Outcome
The data came from 3 RCTs testing different interventions to prevent postpartum blood loss. All 3 trials measured blood loss volume by using a graduated collector bag. The authors modelled the association between positive quantitative blood loss and positive calculated blood loss with polynomial regression and calculated the Spearman correlation coefficient. The median quantitative blood loss (100 mL, IQR= 50, 275) was significantly lower than the median calculated blood loss (260 mL, IQR= 0, 630). The incidence of abnormal blood loss was lower with quantitative blood loss than calculated blood loss. Quantitative blood loss and calculated blood loss were significantly but moderately correlated (Spearman coefficient= 0.44). The association between them was not linear, and their difference tended to increase with blood loss. Negative calculated blood loss values occurred in 23% (1,958/8,341) of individuals; among them, more than 99% (1,939/1,958) had quantitative blood loss ≤ 500 mL.
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Improving Preparedness of Emergency Medicine Residents in the Management Postpartum Hemorrhage: a randomized controlled study of two pedagogical approaches
Casper S, Kayani T, Galerneau F, Evans L, Pal L
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2022
Abstract
OBJECTIVE To evaluate a novel curriculum to enhance knowledge and preparedness of Emergency Medicine (EM) residents in the management of postpartum hemorrhage (PPH) METHODS A randomized controlled trial examined two pedagogical approaches. Following baseline testing of knowledge and confidence in PPH management, participants were randomized to receive a didactic lecture on PPH management (group A, n=14) or to the didactic lecture followed by simulation-based training on PPH management and debriefing (group B, n=16). Post-intervention, proficiency in PPH management was evaluated by clinical skills simulation and post-intervention assessment for participants. The change in the mean test and clinical skills scores were compared using student's t test. Linear regression examined the effects of covariates. RESULTS Both forms of intervention increased participants' knowledge (group A: mean=2.50 CI (1.63, 3.37), p<0.001; group B: mean=1.56 CI (0.89, 2.24), p<0.001) of and confidence (group A: mean=1.00 (0.46, 1.54),p=0.003; group B: mean=1.00 CI (0.52, 1.48),p=0.001) in PPH management, relative to baseline. However, addition of simulation and debriefing to didactic session did not offer any advantage (knowledge: mean=-0.94 CI (-1.97, 0.10), p=0.074; confidence: mean=0.00 CI (-0.66,0.66), p=1.000). CONCLUSION Delivery of a structured curriculum led to improvement of knowledge and confidence in the management of PPH by EM residents.
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Preparing for obstetric anaesthesia - an educational randomised controlled trial comparing e-learning to written course material
Andersson ML, Duch P, Bessmann EL, Lundstrøm LH, Ekelund K
Acta anaesthesiologica Scandinavica. 2022
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Abstract
BACKGROUND E-learning is increasingly used in postgraduate medical education. Its numerous benefits include an enhanced learning experience through learning style individualisation, interactive elements, and assessment through tests and quizzes. Current meta-analyses conclude that the overall effectiveness of e-learning is comparable to traditional teaching modalities. However, studies demonstrating its benefits are heterogeneous and of varying quality. This randomised controlled trial aims to investigate whether contemporary e-learning completed prior to a course in obstetric anaesthesia prepares the course participants better than self-study of written course material. METHODS A randomised controlled trial allocated second-year resident anaesthetists to receive either e-learning in postpartum haemorrhage and written course material in preeclampsia or e-learning in preeclampsia and written course material in postpartum haemorrhage, prior to a compulsory course in obstetric anaesthesia. The primary outcome was knowledge after completion of e-learning before the course, assessed by type X multiple-choice questions with a score ranging from zero to 35. The secondary outcomes were anxiety level before course simulations, performance during course simulations, and knowledge four and 12 weeks after the course. RESULTS The per protocol analysis of the primary outcome included 45 participants and demonstrated a mean difference of 1.8 (95% CI 0.7 to 2.9; p=0.002) in knowledge after completion of e-learning before the course, in favour of e-learning compared to written course material. There were no statistically significant differences in the secondary outcomes. CONCLUSION This blinded parallel group randomised controlled trial found a numerically small but statistically significant difference in knowledge favouring e-learning over written course material.
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Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage after Cesarean or Vaginal Delivery: A Single-Center Randomized Controlled Trial
Lumbreras-Marquez MI, Singh S, King CH, Nelson CI, Jespersen KN, Fields KG, Wang P, Carusi DA, Farber MK
Journal of gynecology obstetrics and human reproduction. 2022;:102470
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Impact of "natural" cesarean delivery on peripartum blood loss: A randomized controlled trial
Zafran N, Garmi G, Abdelgani S, Inbar S, Romano S, Salim R
American journal of obstetrics & gynecology MFM. 2022;:100642
Abstract
BACKGROUND Early skin to skin contact after vaginal delivery increases milk production and may increase oxytocin release, leading to reduction in postpartum hemorrhage (PPH) rate. OBJECTIVE To examine the impact of "natural" cesarean deliveries (NCD) on perioperative maternal blood loss. STUDY DESIGN This is a randomized controlled trial conducted at a single university affiliated medical center, between August 2016 and February 2018. Term singleton gestations scheduled for a planned CD under spinal anesthesia were included. Women were randomized at a ratio of 1:1 to NCD (study group) or traditional CD (control group) during the routine preoperative assessment. Women in the study group watched fetal extraction, had early skin to skin contact, and breastfed until the end of surgery. Neonates in the control group were presented to the mother for few minutes. Blood samples were drawn from all women, during fascia closure, to determine oxytocin levels using an ELISA kit. The Laboratory component was performed after recruitment completion and was accomplished in February 2019. The primary outcome was postpartum hemoglobin (Hb) levels. To detect a difference of 0.5 g/dL between the groups with α = .05 and β = 80%, 214 women were needed. RESULTS Of 214 women that were randomized, 23 were excluded. There were no significant differences in demographic and obstetric variables between the groups. Postpartum Hb levels were 10.1±1.1 and 10.3±1.3 g/dL in the study and control groups, respectively (P = .19). There were no significant differences in rates of PPH and blood transfusion. Maternal pain scores, satisfaction, and exclusive breastfeeding, were comparable. Maternal oxytocin blood levels were 389.5±183.7 and 408.5±233.6 pg/mL in the study and control groups, respectively (P = .96). Incidence of neonatal hypothermia was comparable between the groups (P=.13). CONCLUSIONS NCD does not affect perioperative Hb level or maternal oxytocin blood concentration. CLINICAL TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02768142.
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Thromboelastometry-guided treatment algorithm in postpartum haemorrhage: a randomised, controlled pilot trial
Jokinen S, Kuitunen A, Uotila J, Yli-Hankala A
British journal of anaesthesia. 2022
Abstract
BACKGROUND Postpartum haemorrhage causes significant mortality among parturients. Early transfusion of blood products based on clinical judgement and conventional coagulation testing has been adapted to the treatment of postpartum haemorrhage, but rotational thromboelastometry (ROTEM) may provide clinicians means for a goal-directed therapy to control coagulation. We conducted a parallel design, randomised, controlled trial comparing these two approaches. We hypothesised that a ROTEM-guided protocol would decrease the need for red blood cell transfusion. METHODS We randomised 60 parturients with postpartum haemorrhage of more than 1500 ml to receive either ROTEM-guided or conventional treatment, with 54 patients included in the final analysis. The primary outcome was consumption of blood products, and secondarily we assessed for possible side-effects of managing blood loss such as thromboembolic complications, infections, and transfusion reactions. RESULTS The median (25th-75th percentile) number of RBC units transfused was 2 (1-4) in the ROTEM group and 3 (2-4) in the control group (P=0.399). The median number of OctaplasLG® units given was 0 in both groups (0-0 and 0-2) (P=0.030). The median total estimated blood loss was 2500 ml (2100-3000) in the ROTEM group and 3000 ml (2200-3100) in the control group (P=0.033). No differences were observed in secondary outcomes. CONCLUSIONS ROTEM-guided treatment of postpartum haemorrhage could have a plasma-sparing effect but possibly only a small reduction in total blood loss. CLINICAL TRIAL REGISTRATION NCT02461251.
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Comparative satisfaction and effectiveness of virtual simulation and usual supervised work for postpartum hemorrhage management: a crossover randomized controlled trial
Voillequin S, Rozenberg P, Letutour K, Rousseau A
BMC medical education. 2022;22(1):709
Abstract
BACKGROUND Because virtual simulation promotes learning and cognitive skill development, it may be useful for teaching students to manage postpartum hemorrhage (PPH) and its complex decision algorithm. OBJECTIVE This study aimed to compare the satisfaction and effectiveness of virtual simulation with usual supervised work in producing knowledge and satisfaction. METHODS This two-center two-stage crossover randomized controlled trial included student midwives. One group underwent the virtual simulation intervention in the first period (January 2018) and the usual supervised classroom work in the second (May 2018); the other group followed the reverse chronology. Satisfaction was the primary outcome. The secondary outcome was knowledge of the PPH management algorithm, assessed by responses to a case vignette after each intervention session. RESULTS The virtual simulation -supervised work (VS-SW) chronology was allocated to 48 students, and its inverse (SW-VS) to 47; Satisfaction was significantly higher for the virtual simulation for its overall grade (6.8 vs. 6.1, P = 0.009), engagingness (very good 82.1% vs. 24.3%, P < 0.001), and ease of use (very good 77.9% vs. 46.1%, P < 0.001). Knowledge did not differ between the two groups (respectively, 89.5% versus 83.5%, P = 0.3). CONCLUSION Satisfaction is higher with virtual simulation without lowering knowledge scores, which argues for the use of such innovative teaching strategies. This could lead to an increase in students' motivation to learn.
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Measurement of postpartum blood loss using a new two-set liquid collection bag for vaginal delivery: A prospective, randomized, case control study
Wang F, Lu N, Weng X, Tian Y, Sun S, Li B
Medicine. 2021;100(19):e25906
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Abstract
BACKGROUND Postpartum hemorrhage (PPH) is a major obstetric complication, and the real-time measurement of blood loss is important in the management and treatment of PPH. We designed a new two-set liquid collection bag (TSLCB) for measuring postpartum blood loss in vaginal delivery. The aim of this study was to evaluate the effectiveness of the TSLCB in separating the blood from the amniotic fluid during vaginal delivery and in determining the accuracy of the measured postpartum blood loss. METHODS A prospective, randomized, case control study was conducted in the Women's Hospital, Zhejiang University School of Medicine, from March 2018 to April 2018. Sixty single pregnant women with spontaneous labor at 37-41 weeks without maternal complications were randomly divided into the experimental and control groups. The TSLCB was used to evaluate separately the amount of blood and amniotic fluid. For the control group, visual estimation and traditional plastic blood-collecting consumables were used to estimate the amount of postpartum blood loss. The measured blood loss between the two groups was compared, and the association of the measured blood loss with various clinical lab indices and vital signs was investigated. RESULTS The TSLCB (the experimental group) improved the detection of the measured blood loss compared with visual estimation and the traditional method (the control group) (P < .05). In the experimental group, correlation analysis showed that the measured blood loss at delivery and within 24 h of delivery was significantly associated with the decreased hemoglobin level, red blood cell count, and hematocrit level of patients (r = -0.574, -0.455, -0.437; r = 0.-595, -0.368, -0.374; P < .05). In the control group, only the measured blood loss within 24 h of delivery was associated with the decreased hemoglobin level (r = -0.395, P < .05). No blood transfusion and plasma expanders were required in the treatment of PPH for both groups. CONCLUSIONS The TSLCB can be used to accurately measure the postpartum blood loss in vaginal delivery by medical personnel.
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Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial
Giblin L, Vousden N, Nathan H, Gidiri F, Goudar S, Charantimath U, Sandall J, Seed PT, Chappell LC, Shennan AH
BMC pregnancy and childbirth. 2021;21(1):317
Abstract
BACKGROUND Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds. METHODS This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities. RESULTS Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39-2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39-0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy). CONCLUSIONS Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings. TRIAL REGISTRATION This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016).