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The French National Authority for Health (HAS) recently issued guidelines for patient blood management (PBM) in surgical procedures. These recommendations are based on three usual pillars of PBM: optimizing red cell mass, minimizing blood loss and optimizing anemia tolerance. In the preoperative period, these guidelines recommend detecting anemia and iron deficiency and taking corrective measures well in advance of surgery, when possible, in case of surgery with moderate to high bleeding risk or known preoperative anemia. In the intraoperative period, the use of tranexamic acid and some surgical techniques are recommended to limit bleeding in case of high bleeding risk or in case of hemorrhage, and the use of cell salvage is recommended in some surgeries with a major risk of transfusion. In the postoperative period, the limitation of blood samples is recommended but the monitoring of postoperative anemia must be carried out and may lead to corrective measures (intravenous iron in particular) or more precise diagnostic assessment of this anemia. A "restrictive" transfusion threshold considering comorbidities and, most importantly, the tolerance of the patient is recommended postoperatively. The implementation of a strategy and a program for patient blood management is recommended throughout the perioperative period in healthcare establishments in order to reduce blood transfusion and length of stay. This article presents an English translation of the HAS recommendations and a summary of the rationale underlying these recommendations.
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OBJECTIVE: Post-partum hemorrhage (PPH) is the leading preventable cause of worldwide maternal morbidity and mortality. Risk factors for psychological disorders following PPH are currently unknown. HELP-MOM study aimed to determine the incidence and identify risk factors for psychological disorders following PPH. METHODS: HELP-MOM study was a prospective, observational, national, and multicentre study including patients who experienced severe PPH requiring sulprostone. The primary endpoint was the occurrence of psychological disorders (anxiety and/or post-traumatic disorder and/or depression) following PPH, assessed at 1, 3, and 6 months after delivery using HADS, IES-R, and EPDS scales. RESULTS: Between November 2014 and November 2016, 332 patients experienced a severe PPH and 236 (72%) answered self-questionnaires at 1, 3, and 6 months. A total of 161 (68%) patients declared a psychological disorder following severe PPH (146 (90.1%) were screened positive for anxiety, 96 (58.9%) were screened positive for post-traumatic stress disorder, and 94 (57.7%) were screened positive for post-partum depression). In multivariable analysis, the use of intra-uterine tamponnement balloon was associated with a lower risk to be screened positive for psychological disorder after severe PPH (OR = 0.33 [IC95% 0.15-0.69], p = 0.004, and after propensity score matching (OR=0.34 [IC95% 0.12-0.94], p = 0.04)). Low hemoglobin values during severe PPH management were associated with a higher risk of being screened positive for psychological disorders. Finally, we did not find differences in desire or pregnancy between patients without or with psychological disorders occurring in the year after severe PPH. DISCUSSION: Severe PPH was associated with significant psychosocial morbidity including anxiety, post-traumatic disorder, and depression. This should engage a psychological follow-up. Large cohorts are urgently needed to confirm our results. REGISTRATION: ClinicalTrials.gov under number NCT02118038.
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Hemorragia Pós-Parto , Transtornos de Estresse Pós-Traumáticos , Feminino , Humanos , Gravidez , Ansiedade/epidemiologia , Ansiedade/etiologia , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/terapia , Período Pós-Parto , Estudos Prospectivos , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/etiologiaRESUMO
Postpartum haemorrhage (PPH) remains the leading cause of pregnancy-related deaths worldwide. Typically, bleeding is controlled by timely obstetric measures in parallel with resuscitation and treatment of coagulopathy. Early recognition of abnormal coagulation is crucial and haemostatic support should be considered simultaneously with other strategies as coagulopathies contribute to the progression to massive haemorrhage. However, there is lack of agreement on important topics in the current guidelines for management of PPH. A clinical definition of PPH is paramount to understand the situation to which the treatment recommendations relate; however, reaching a consensus has previously proven difficult. Traditional definitions are based on volume of blood loss, which is difficult to monitor, can be misleading and leads to treatment delay. A multidisciplinary approach to define PPH considering vital signs, clinical symptoms, coagulation and haemodynamic changes is needed. Moreover, standardised algorithms or massive haemorrhage protocols should be developed to reduce the risk of morbidity and mortality and improve overall clinical outcomes in PPH. If available, point-of-care testing should be used to guide goal-directed haemostatic treatment. Tranexamic acid should be administered as soon as abnormal bleeding is recognised. Fibrinogen concentrate rather than fresh frozen plasma should be administered to restore haemostasis where there is elevated risk of fibrinogen deficiency (e.g., in catastrophic bleeding or in cases of abruption or amniotic fluid embolism) as it is a more concentrated source of fibrinogen. Lastly, organisational considerations are equally as important as clinical interventions in the management of PPH and have the potential to improve patient outcomes.
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Hemostáticos , Hemorragia Pós-Parto , Humanos , Feminino , Hemostáticos/uso terapêutico , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/terapia , FibrinogênioRESUMO
BACKGROUND: The optimal dose of tranexamic acid to inhibit hyperfibrinolysis in postpartum haemorrhage is unclear. Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Cesarean Delivery (TRACES) was a double-blind, placebo-controlled, randomised, multicentre dose-ranging study to determine the dose-effect relationship for two regimens of intravenous tranexamic acid vs placebo. METHODS: Women experiencing postpartum haemorrhage during Caesarean delivery were randomised to receive placebo (n=60), tranexamic acid 0.5 g (n=57), or tranexamic acid 1 g i.v. (n=58). Biomarkers of fibrinolytic activation were assayed at five time points, with inhibition of hyperfibrinolysis defined as reductions in the increase over baseline in D-dimer and plasmin-antiplasmin levels and in the plasmin peak time. RESULTS: In the placebo group, hyperfibrinolysis was evidenced by a mean increase over baseline [95% confidence interval] of 93% [68-118] for D-dimer level at 120 min and 56% [25-87] for the plasmin-antiplasmin level at 30 min. A dose of tranexamic acid 1 g was associated with smaller increases over baseline (D-dimers: 38% [13-63] [P=0.003 vs placebo]; plasmin-antiplasmin: -2% [-32 to 28] [P=0.009 vs placebo]). A dose of tranexamic acid 0.5 g was less potent, with non-significant reductions (D-dimers: 58% [32-84] [P=0.06 vs placebo]; plasmin-antiplasmin: 13% [18-43] [P=0.051]). Although both tranexamic acid doses reduced the plasmin peak, reduction in plasmin peak time was significant only for the 1 g dose of tranexamic acid. CONCLUSIONS: Fibrinolytic activation was significantly inhibited by a dose of intravenous tranexamic acid 1 g but not 0.5 g. Pharmacokinetic-pharmacodynamic modelling of these data might identify the best pharmacodynamic monitoring criteria and the optimal tranexamic acid dosing regimen for treatment of postpartum haemorrhage. CLINICAL TRIAL REGISTRATION: NCT02797119.
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Antifibrinolíticos , Transtornos da Coagulação Sanguínea , Hemorragia Pós-Parto , Ácido Tranexâmico , Humanos , Gravidez , Feminino , Ácido Tranexâmico/uso terapêutico , Hemorragia Pós-Parto/tratamento farmacológico , Fibrinolisina , Método Duplo-Cego , Cesárea , BiomarcadoresRESUMO
PURPOSE: Individuals in late pregnancy are at risk of significant hemodynamic variations, especially during Cesarean delivery. Although non-invasive monitoring might enable the early detection of variations in cardiac output (CO), clinical validation is lacking. METHODS: In a prospective, single-center study, we measured CO simultaneously with finger plethysmography and transthoracic echocardiography in 100 third-trimester pregnant individuals in the supine and left lateral decubitus (LLD) positions. RESULTS: A Bland-Altman analysis revealed a mean (standard deviation) bias of 1.36 (1.04) L·min-1 in the supine position (95% limits of agreement, -0.68 to 3.4 L·min-1; percent error, 26.6%), indicating overestimation by finger plethysmography. The intra-class correlation coefficient was 0.43 (95% confidence interval [CI], 0.33 to 0.51). Regarding the changes in CO induced by the supine-to-LLD transition, the concordance rate in a four-quadrant plot was 98.3% (95% CI, 91.1 to 99.9%). CONCLUSION: Our study showed a poor reliability of finger plethysmography for static measurement of CO. Nevertheless, finger plethysmography had a reasonably high concordance rate for the detection of CO changes secondary to positional changes in late-pregnant individuals. STUDY REGISTRATION DATE: www. CLINICALTRIALS: gov (NCT03735043); registered 8 November 2018.
RéSUMé: OBJECTIF: Les personnes en fin de grossesse sont à risque de variations hémodynamiques importantes, en particulier pendant un accouchement par césarienne. Bien que le monitorage non invasif puisse permettre la détection précoce des variations du débit cardiaque (DC), la validation clinique de ce type de monitorage fait défaut. MéTHODE: Dans une étude prospective monocentrique, nous avons mesuré le DC simultanément avec la pléthysmographie au doigt et l'échocardiographie transthoracique chez 100 femmes au troisième trimestre de leur grossesse en décubitus dorsal et en décubitus latéral gauche (DLG). RéSULTATS: Une analyse de Bland-Altman a révélé un biais moyen (écart type) de 1,36 (1,04) L·min1 en décubitus dorsal (limites d'agrément à 95 %, -0,68 à 3,4 L·min1; pourcentage d'erreur, 26,6 %), indiquant une surestimation lorsque mesuré par pléthysmographie au doigt. Le coefficient de corrélation intraclasse était de 0,43 (intervalle de confiance [IC] à 95 %, 0,33 à 0,51). En ce qui concerne les changements de DC induits par la transition du décubitus dorsal au décubitus latéral gauche, le taux de concordance dans un diagramme à quatre quadrants était de 98,3 % (IC 95 %, 91,1 à 99,9 %). CONCLUSION: Notre étude a montré une faible fiabilité de la pléthysmographie au doigt pour la mesure statique du DC. Néanmoins, la pléthysmographie au doigt avait un taux de concordance raisonnablement élevé pour la détection des changements de DC secondaires aux changements de position chez les patientes en fin de grossesse. www.clinicaltrials.gov (NCT03735043); enregistrée le 8 novembre 2018.
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Pletismografia , Termodiluição , Feminino , Gravidez , Humanos , Estudos Prospectivos , Reprodutibilidade dos Testes , Débito Cardíaco , Monitorização FisiológicaRESUMO
The aim of this study was to evaluate the population pharmacokinetics of tranexamic acid (TXA) administered intravenously at a single dose of 0.5 or 1 g in parturients undergoing active hemorrhagic cesarean delivery and to evaluate the influence of patient variables on TXA pharmacokinetics. Subjects from three recruiting centers were included in this PK sub-study if randomized in the experimental group (i.v TXA 0.5 g or 1 g over one minute) of the TRACES study. Blood samples and two urinary samples were collected within 6 h after TXA injection. Parametric non-linear mixed-effect modeling (Monolix v2020R1) was computed. The final covariate model building used 315 blood and 117 urinary concentrations from seventy-nine patients. A two-compartment model with a double first-order elimination from the central compartment best described the data. The population estimates of clearance (CL), central volume of distribution (V1), and half-life for a typical 70 kg patient with an estimated renal clearance of 150 mL/min (Cockroft-Gault) were 0.14 L/h, 9.25 L, and 1.8 h. A correlation between estimated creatinine clearance and CL, body weight before pregnancy, and V1 was found and partly explained the PK variability. The final model was internally validated using a 500-run bootstrap. The first population pharmacokinetic model of TXA in active hemorrhagic caesarean section was successfully developed and internally validated.
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Betacoronavirus , Infecções por Coronavirus/sangue , Pandemias , Pneumonia Viral/sangue , Complicações Hematológicas na Gravidez/etiologia , Complicações Infecciosas na Gravidez/sangue , Tromboembolia/prevenção & controle , Trombofilia/etiologia , Anticoagulantes/uso terapêutico , Autoanticorpos/sangue , Betacoronavirus/isolamento & purificação , Betacoronavirus/fisiologia , Proteínas Sanguíneas/análise , COVID-19 , Transtornos Cerebrovasculares/etiologia , Transtornos Cerebrovasculares/prevenção & controle , Contraindicações de Medicamentos , Infecções por Coronavirus/complicações , Síndrome da Liberação de Citocina/sangue , Síndrome da Liberação de Citocina/etiologia , Coagulação Intravascular Disseminada/tratamento farmacológico , Coagulação Intravascular Disseminada/etiologia , Células Endoteliais/virologia , Feminino , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Tempo de Tromboplastina Parcial , Plasma , Pneumonia Viral/complicações , Hemorragia Pós-Parto/tratamento farmacológico , Hemorragia Pós-Parto/terapia , Gravidez , Complicações Hematológicas na Gravidez/tratamento farmacológico , Transtornos Puerperais/sangue , Transtornos Puerperais/tratamento farmacológico , Transtornos Puerperais/etiologia , SARS-CoV-2 , Tromboembolia/etiologia , Trombofilia/tratamento farmacológico , Ácido Tranexâmico/efeitos adversos , Ácido Tranexâmico/uso terapêuticoRESUMO
BACKGROUND: Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor, which is a period of significant physical activity, can decrease the instrumental vaginal delivery rate. METHODS: In a multicenter, prospective, randomized, controlled trial, healthy adult pregnant women presenting with spontaneous labor were assigned to a "Carbohydrate" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a "Fasting" group (water only). The primary outcome was the instrumental vaginal delivery rate. Secondary outcomes included duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay. Statistical analysis was performed on an intention-to-treat basis. The primary outcome was tested with the "Fasting" group as the reference group. The P values for secondary outcomes were adjusted for multiple comparisons. The differences between groups are reported with 99% confidence interval (CI). RESULTS: A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group). There was no difference in the rate of instrumental delivery between the Carbohydrate (21.0%) and the Fasting (22.4%) groups (difference, -1.4%; 99% CI, -4.9 to 2.2). No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0). CONCLUSIONS: Carbohydrate intake during labor did not modify the rate of instrumental vaginal delivery.
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Carboidratos/administração & dosagem , Trabalho de Parto/fisiologia , Adulto , Cesárea , Parto Obstétrico , Água Potável/administração & dosagem , Extração Obstétrica , Feminino , Sucos de Frutas e Vegetais , Humanos , Ocitócicos/administração & dosagem , Gravidez , Estudos Prospectivos , Instrumentos CirúrgicosRESUMO
INTRODUCTION: To determine a minimum threshold of medical staffing needs (obstetricians-gynecologists, anesthesiologists-resuscitation specialists, nurse-anesthetists, pediatricians, and midwives) to ensure the safety and quality of care for unscheduled obstetrics-gynecology activity. MATERIALS AND METHODS: Face to face meetings of French healthcare professionals involved in perinatal care in different types of practices (academic hospital, community hospital or private practice) who belong to French perinatal societies: French National College of Gynecologists-Obstetricians (CNGOF), the French Society of Anesthesia and Resuscitation Specialists (SFAR), the French Society of Neonatology (SFN), the French Society of Perinatal Medicine (SFMP), the National College of French Midwives (CNSF), and the French Federation of Perinatal Care Networks (FFRSP). RESULTS: Different minimum thresholds for each category of care provider were proposed according to the number of births/year in the facility. These minimum thresholds can be modulated upwards as a function of the level of care (Level 1, 2 or 3 for perinatal centers), existence of an emergency department, and responsibilities as a referral center for maternal-fetal and/or surgical care. For example, an obstetrics-gynecology department handling 3000-4500 births per year without serving as a referral center must have an obstetrician-gynecologist, an anesthesiologist-resuscitation specialist, a nurse-anesthetist, and a pediatrician onsite specifically to provide care for unscheduled obstetrics-gynecology needs and a second obstetrician-gynecologist available within a time compatible with security requirements 24/7; the number of midwives always present (24/7) onsite and dedicated to unscheduled care is 5.1 for 3000 births and 7.2 for 4500 births. A maternity unit's occupancy rate must not exceed 85 %. CONCLUSION: The minimum thresholds proposed here are intended to improve the safety and quality of care of women who require unscheduled care in obstetrics-gynecology or during the perinatal period.
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Serviços Médicos de Emergência/provisão & distribuição , Ginecologia/métodos , Mão de Obra em Saúde/estatística & dados numéricos , Obstetrícia/métodos , Admissão e Escalonamento de Pessoal/estatística & dados numéricos , Atenção à Saúde/normas , Atenção à Saúde/estatística & dados numéricos , Serviços Médicos de Emergência/normas , Feminino , França , Ginecologia/normas , Humanos , Tocologia/métodos , Tocologia/normas , Obstetrícia/normas , Admissão e Escalonamento de Pessoal/normas , Gravidez , Melhoria de QualidadeRESUMO
BACKGROUND: Among the severe complications of preeclampsia (PE), acute kidney injury (AKI) is problematic if features of thrombotic microangiopathy (TMA) are present. Although a haemolysis enzyme liver low-platelets syndrome is considerably more frequent, it is vital to rule out a flare of atypical haemolytic and uraemic syndrome (aHUS). Our objective was to improve differential diagnosis procedures in post-partum AKI. METHODS: A total of 105 cases of post-partum AKI, admitted to nine different regional French intensive care units from 2011 to 2015, were analysed. Analysis included initial and final diagnosis, renal features, haemostasis and TMA parameters, with particular focus on the dynamics of each component within the first days following delivery. A classification and regression tree (CART) was used to construct a diagnostic algorithm. RESULTS: AKI was attributed to severe PE (n = 40), post-partum haemorrhage (n = 33, including 13 renal cortical necrosis) and 'primary' TMA (n = 14, including 10 aHUS and 4 thrombotic thrombocytopenic purpura). Congruence between initial and final diagnosis was low (63%). The dynamics of haemoglobin, haptoglobin and liver enzymes were poorly discriminant. In contrast, the dynamic pattern of platelets was statistically different between primary TMA-related AKI and other groups. CART analysis independently highlighted the usefulness of platelet trajectory in the diagnostic algorithm. Limitations of this study include that only the most severe cases were included in this retrospective study, and the circumstantial complexity is high. CONCLUSION: Trajectory of platelet count between admission and Day 3 helps to guide therapeutic decisions in cases of TMA-associated post-partum AKI. Our study also strongly suggests that during the post-partum period, there may be a risk of transient, slowly recovering TMA in cases of severe endothelial injury in women without a genetic mutation known to induce aHUS.
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Injúria Renal Aguda/diagnóstico , Biomarcadores/metabolismo , Placenta/patologia , Período Pós-Parto , Microangiopatias Trombóticas/complicações , Injúria Renal Aguda/etiologia , Injúria Renal Aguda/terapia , Adulto , Feminino , Humanos , Placenta/metabolismo , Contagem de Plaquetas , Gravidez , Estudos RetrospectivosRESUMO
Patient blood management (PBM) is the timely application of evidence-informed medical and surgical concepts designed to maintain haemoglobin concentration, optimise haemostasis, and minimise blood loss in an effort to improve patient outcomes. The aim of this consensus statement is to provide recommendations on the prevention and treatment of postpartum haemorrhage as part of PBM in obstetrics. A multidisciplinary panel of physicians with expertise in obstetrics, anaesthesia, haematology, and transfusion medicine was convened by the Network for the Advancement of Patient Blood Management, Haemostasis and Thrombosis (NATA) in collaboration with the International Federation of Gynaecology and Obstetrics (FIGO), the European Board and College of Obstetrics and Gynaecology (EBCOG), and the European Society of Anaesthesiology (ESA). Members of the task force assessed the quantity, quality and consistency of the published evidence, and formulated recommendations using the system developed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group. The recommendations in this consensus statement are intended for use by clinical practitioners managing perinatal care of women in all settings, and by policy-makers in charge of decision making for the update of clinical practice in health care establishments.
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Hemorragia Pós-Parto/prevenção & controle , Hemorragia Pós-Parto/terapia , Anemia/prevenção & controle , Transfusão de Sangue/métodos , Gerenciamento Clínico , Feminino , Hemostasia , Humanos , Hemorragia Pós-Parto/sangue , Hemorragia Pós-Parto/etiologia , Gravidez , Fatores de Risco , Sociedades MédicasRESUMO
BACKGROUND: Evidence increases that a high or a standard dose of tranexamic acid (TA) reduces postpartum bleeding. The TRACES pharmacobiological substudy aims to establish a therapeutic strategy in hemorrhagic (H) Cesarean section (CS) with respect to the intensity of fibrinolysis by using innovative assays. METHOD/DESIGN: The TRACES trial is a multicenter, randomized, double-blind, placebo-controlled, TA dose-ranging study that measures simultaneously plasmatic and uterine and urine TA concentrations and the plasmin peak inhibition tested by a simultaneous thrombin plasmin generation assay described by Van Geffen (novel hemostasis assay [NHA]). Patients undergoing H CS (>800 mL) will receive blindly TA 0.5 g or 1 g or placebo. A non-hemorrhagic (NH) group will be recruited to establish plasmin generation profile. Venous blood will be sampled before, at the end, and then at 30, 60, 120, and 360 min after injection. Uterine bleeding will be sampled after injection. Urine will be sampled 2 h and 6 h after injection. The number of patients entered into the study will be 114 H + 48 NH out of the 390 patients of the TRACES clinical trial. DISCUSSION: To explore the two innovative assays, a preliminary pilot study was conducted. Blood samples were performed repeatedly in patients undergoing either a H (>800 mL) or NH (<800 mL) CS and in non-pregnant women (NP). H patients received TA (0-2 g). Dose-dependent TA plasmatic concentrations were determined by LC-MS/MS quantification. Plasmin generation and its inhibition were tested in vitro and in vivo using the simultaneous thrombin-plasmin generation assay (STPGA). The pilot study included 15 patients in the H group, ten patients in the NH group, and seven patients in the NP group. TA plasmatic concentration showed a dose-dependent variation. STPGA inter-assay variation coefficients were < 20% for all plasmin parameters. Inter-individual dispersion of plasmin generation capacity was higher in H and NH groups than in NP group. Profile evolution over time was different between groups. This preliminary technical validation study allows TRACES pharmacobiological trial to be conducted. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02797119. Registered on 13 June 2016.
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Antifibrinolíticos/administração & dosagem , Perda Sanguínea Cirúrgica/prevenção & controle , Cesárea/efeitos adversos , Fibrinólise/efeitos dos fármacos , Hemorragia Pós-Parto/prevenção & controle , Ácido Tranexâmico/administração & dosagem , Antifibrinolíticos/efeitos adversos , Antifibrinolíticos/farmacocinética , Biomarcadores/sangue , Método Duplo-Cego , Cálculos da Dosagem de Medicamento , Monitoramento de Medicamentos/métodos , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Fibrinolisina/metabolismo , França , Humanos , Estudos Multicêntricos como Assunto , Projetos Piloto , Hemorragia Pós-Parto/sangue , Hemorragia Pós-Parto/diagnóstico , Gravidez , Dados Preliminares , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Ácido Tranexâmico/efeitos adversos , Ácido Tranexâmico/farmacocinética , Resultado do TratamentoRESUMO
: Thromboembolic events in the pregnant and postpartum patient remain rare but potentially fatal complications. The aim of this section was to analyse the few prospective studies addressing the issue of thromboprophylaxis following a surgical procedure during and immediately after pregnancy, as well as national guidelines, and to propose European guidelines on this specific condition. Thromboprophylaxis is broadly recommended due to the combined risks of surgery and pregnancy or the postpartum period, regardless of the mode of delivery. We recommend prophylactic thromboprophylaxis following surgery during pregnancy or the postpartum period when they imply, as a consequence, bed rest, until full mobility is recovered (Grade 1C). Similarly, thromboprophylaxis should be used in cases of perioperative infection during pregnancy or the postpartum period. Concerning thromboprophylaxis following a caesarean section, it seems avoidable only in elective procedures in low-risk patients, after a normal pregnancy, and with an early rehabilitation protocol. The duration of thromboprophylaxis following caesarean section should be at least 6 weeks for high-risk patients, and at least 7 days for the other patients requiring anticoagulation (Grade 1C).
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Cesárea/efeitos adversos , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Assistência Perioperatória/normas , Cuidado Pós-Natal/normas , Complicações na Gravidez/cirurgia , Tromboembolia Venosa/prevenção & controle , Adulto , Anestesiologia/métodos , Anestesiologia/normas , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/normas , Repouso em Cama/normas , Cuidados Críticos/métodos , Cuidados Críticos/normas , Europa (Continente) , Feminino , Heparina de Baixo Peso Molecular/administração & dosagem , Heparina de Baixo Peso Molecular/efeitos adversos , Heparina de Baixo Peso Molecular/normas , Humanos , Assistência Perioperatória/métodos , Cuidado Pós-Natal/métodos , Período Pós-Parto , Gravidez , Fatores de Risco , Sociedades Médicas/normas , Tromboembolia Venosa/etiologiaRESUMO
OBJECTIVE: To compare the validity of two previously published diagnostic scores of disseminated intravascular coagulation (DIC) in pregnant women admitted to ICU for an acute thrombotic or hemorrhagic complication of delivery and postpartum. METHODS: This was a population based retrospective study of 154 patients admitted to ICU for severe delivery and postpartum complications in a University Hospital. A recently published score (adapted to physiological changes of pregnancy and based on three components: platelet count, prothrombin time difference and fibrinogen) was compared to the International Society for Thrombosis and Hemostasis (ISTH) score (based on four components: platelet count, fibrinogen, prothrombin time, and fibrin related marker). Both scores were calculated at delivery, ICU admission (day 0), day 1 and day 2 during the postpartum ICU stay. The validity of both scores was assessed by comparison with the consensual and blinded analysis of two experts. The sensitivity, specificity, and area under the curve (AUC) of each score were calculated at each time and overall by generalized linear mixed model. The agreement between the two scores was evaluated by the Kappa coefficient. RESULTS: The new score had a sensitivity of 0.78, a specificity of 0.97 (p <0.01) and a global AUC of 96% while the ISTH score had a sensitivity of 0.31, a specificity of 0.99 and an AUC of 94% (p <0.01). The Kappa coefficient of correlation between both scores was 0.35. The lower sensitivity of the ISTH score was mainly explained by the lack of fibrinogen and fibrin-related peptides thresholds adapted to the physiological changes of coagulation induced by pregnancy. CONCLUSION: The new DIC score seem highly discriminant in the subset of patients admitted to the ICU after delivery for an acute specific complication. The ISTH score is not recommended in pregnant women because of its poor sensitivity.
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Coagulação Intravascular Disseminada/diagnóstico , Coagulação Intravascular Disseminada/epidemiologia , Hospitalização , Unidades de Terapia Intensiva , Complicações Hematológicas na Gravidez/diagnóstico , Complicações Hematológicas na Gravidez/epidemiologia , Adulto , Testes de Coagulação Sanguínea , Coagulação Intravascular Disseminada/etiologia , Feminino , Humanos , Masculino , Vigilância da População , Gravidez , Curva ROC , Valores de Referência , Estudos Retrospectivos , Fatores de Risco , Índice de Gravidade de DoençaAssuntos
Serviços Médicos de Emergência/métodos , Parada Cardíaca/terapia , Complicações Cardiovasculares na Gravidez/terapia , Adulto , Feminino , Parada Cardíaca/complicações , Humanos , Gravidez , Complicações Cardiovasculares na Gravidez/diagnóstico , Complicações Cardiovasculares na Gravidez/epidemiologiaRESUMO
INTRODUCTION: Evaluating the fertility and pregnancy outcomes in systemic sclerosis (SSc) women is challenging. Studies are still limited or subject to potential methodological biases. Areas covered: This work is a comprehensive review of the literature. We discuss the potential impact of SSc on women's pregnancy outcomes and the effects of pregnancy on SSc. We summarize the physiological changes during pregnancy and describe our experience. Expert commentary: Although the miscarriage rate does not appear increased in SSc, women are exposed to a higher risk of premature birth and intrauterine growth restriction compared with the general population. Early diffuse cutaneous SSc and use of corticosteroids are risk factors, whereas folic acid use prevents against premature birth. All SSc women wishing to conceive should be counselled during a preconception visit. Physiological changes arising during pregnancy may be the source of clinical problems in SSc women with organs with limited capacities.
Assuntos
Aborto Espontâneo/epidemiologia , Retardo do Crescimento Fetal/epidemiologia , Complicações na Gravidez/epidemiologia , Resultado da Gravidez , Escleroderma Sistêmico/epidemiologia , Feminino , França/epidemiologia , Humanos , Gravidez , RiscoRESUMO
BACKGROUND: Postpartum haemorrhage (PPH) remains the leading cause for maternal mortality worldwide. Hypofibrinogenaemia has been identified as a major risk factor for progress towards severe PPH. The efficacy of fibrinogen concentrate supplementation in PPH has been shown in various clinical settings but the level of evidence is not sufficient to prove the benefit, evaluate the risks, and determine the value, timing and dose of fibrinogen supplementation in PPH. The FIDEL trial objective is to evaluate the impact of a therapeutic strategy based on the early administration of human fibrinogen concentrate compared to the current practice based on late administration in severe PPH patients requiring second line uterotonics. METHODS/DESIGN: This is a prospective multicentre, randomised, double-blind, placebo-controlled trial. A total of 412 patients will be randomised if they meet the following criteria: female patients≥18 years old, vaginal delivery, PPH requiring IV administration of prostaglandins (sulprostone) after 20 to 30minutes of oxytocin failure. The participants are assigned to receive either fibrinogen 3g or placebo infusions. The primary endpoint is a composite endpoint defined as the percentage of patients losing at least 4g/dL of Hb, and/or requiring a transfusion of at least 2 units of packed red blood cells, within the 48hours following fibrinogen administration. DISCUSSION: The purpose of this study is to demonstrate the efficacy and safety of an early fibrinogen concentrate infusion in uncontrolled active PPH.
Assuntos
Transtornos da Coagulação Sanguínea/tratamento farmacológico , Parto Obstétrico , Fibrinogênio/uso terapêutico , Hemostáticos/uso terapêutico , Hemorragia Pós-Parto/tratamento farmacológico , Adolescente , Adulto , Dinoprostona/administração & dosagem , Dinoprostona/análogos & derivados , Dinoprostona/uso terapêutico , Método Duplo-Cego , Feminino , Fibrinogênio/efeitos adversos , Hemostáticos/efeitos adversos , Humanos , Monitorização Fisiológica , Ocitócicos , Ocitocina , Segurança do Paciente , Gravidez , Estudos Prospectivos , Falha de Tratamento , Adulto JovemRESUMO
BACKGROUND: The rate of neuraxial analgesia during labor in France is one of the highest among high-income countries: 77% of vaginal deliveries in 2010. In this context, the question of how women's preferences for delivering without neuraxial analgesia relate to actual use is of interest. Our objective was to study the factors associated with women's initial preference for labor without neuraxial analgesia and those associated with its use in women who initially preferred not to have it. METHODS: We used data from the 2010 French National Perinatal Survey, a cross-sectional study of a representative sample of all births in France. Data were collected from interviews with mothers in the postpartum ward and from medical records. Our sample included 7123 women who had vaginal deliveries and were at low risk for cesarean delivery. The factors analyzed were maternal sociodemographic characteristics, prenatal care, childbirth class attendance, labor management, and organization of maternity units. Multilevel Poisson regression models were used to study factors associated with women's initial preference in the overall population and to study factors associated with actual use of neuraxial analgesia in the group of women who initially preferred not to have it. RESULTS: Initially, 26% of our population (n = 1835) preferred to deliver without neuraxial analgesia; this preference was associated with high parity, unfavorable social conditions, and delivery in a public maternity unit. Among these women, 52% (n = 961) delivered with neuraxial analgesia. This discrepancy between initial preference and actual use was significantly associated with nulliparity (adjusted relative risk [aRR] = 1.4; 95% confidence interval [CI], 1.3-1.6), oxytocin augmentation of labor (aRR = 2.4; 95% CI, 2.1-2.7), presence of an anesthesiologist in the unit 24/7 (aRR = 1.4; 95% CI, 1.2-1.6; compared with delivery in hospitals without an anesthesiologist on site 24/7), and high midwife workload (aRR = 1.1; 95% CI, 1.0-1.2). There was no clear association with maternal educational level. CONCLUSIONS: Our results suggest that parity, the management of labor, and availability of anesthesiologists play a major role in the intrapartum decision to use neuraxial analgesia for women who initially preferred not to have it. Further research is necessary in the clinical circumstances leading to this decision and the role of women's demands and medical staff attitudes throughout labor.
Assuntos
Analgesia Obstétrica/psicologia , Analgesia Obstétrica/estatística & dados numéricos , Coleta de Dados , Dor do Parto/psicologia , Trabalho de Parto/psicologia , Participação do Paciente/psicologia , Adulto , Estudos Transversais , Coleta de Dados/métodos , Feminino , França/epidemiologia , Humanos , Dor do Parto/epidemiologia , Dor do Parto/terapia , Manejo da Dor/métodos , Manejo da Dor/psicologia , Gravidez , Adulto JovemRESUMO
BACKGROUND: In this pilot study, we hypothesized that velocity parameters obtained from changes in clot amplitude (A) and clot elasticity (E) measured with thromboelastometry (ROTEM, Tem International GmbH, Munich, Germany) could improve detection of fibrinolysis in whole blood obtained from children undergoing surgery for congenital heart disease. METHODS: Whole blood samples were obtained after induction of general anesthesia. Seven conditions were studied: native whole blood (baseline) and samples with progressive tissue-type plasminogen activator (t-PA) concentrations (102, 255, 512, 1024, 1535, and 2539 units/mL). We calculated velocity curves based on changes in clot amplitude and elasticity between different time points using ROTEM data. The analysis allowed for the determination of the following parameters: the maximum rate of thrombus formation based on amplitude or elasticity and the maximum rate of thrombus lysis measured based on amplitude (MTL) or maximum rate of thrombus lysis measured based on elasticity (MTLe). We compared these parameters with the lysis in relation to maximal clotting firmness and measured 30 minutes after the clotting time (LI30, in percent). RESULTS: Concentrations of t-PA ≥ 255 units/mL resulted in a decrease in LI30 (mean difference, 255 units/mL versus baseline, -31.05%, P < 0.0001) and the maximum rate of thrombus formation based on amplitude (mean difference, 255 units/mL versus baseline, -7.5, P = 0.005). Concentrations of t-PA ≥ 512 units/mL resulted in changes in maximum rate of thrombus formation based on elasticity (mean difference, 512 units/mL versus baseline, -10.9, P = 0.010), MTL (mean difference, 255 units/mL versus baseline, -3.2, P = 0.016), and MTLe (mean difference, 255 units/mL versus baseline, -7.8, P = 0.004). For t-PA concentrations ≥ 512 units/mL, clot formation was abolished. The area under the receiver operating characteristics curves did not differ between LI30, MTL, and MTLe for the detection of minimal fibrinolytic activation (102 units/mL; 0.74, 0.75, and 0.72, respectively, P = 0.708), whereas sensitivity and specificity of the cutoff values 97% for LI30, -0.3 for MTL, and -0.5 for MTLe were 52% and 85%, 83% and 45%, and 83% and 45%, respectively. CONCLUSIONS: Velocity curves based on the amplitudes or clot elasticity could provide objective measurement of clot growth and clot lysis kinetics, allowing detection of even minor fibrinolysis. Further studies are needed to assess the clinical relevance of these parameters.