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OBJECTIVE: To evaluate the influence of ABO and Rh blood groups on morbidity among SARS-CoV-2 infected pregnancies. DESIGN: Prospective observational study. SETTING: 78 centers of the Spanish Obstetric Emergency Group. POPULATION: Pregnant women with SARS-CoV-2 tested with polymerase-chain-reaction between 26-February and 5-November 2020. A cohort of 1278 SARS-CoV-2(+) pregnant women was analyzed and a concurrent comparison group of 1453 SARS-COV-2(-) patients was established. METHODS: Data were collected from medical charts. SARS-COV-2(+) was compared with SARS-COV-2(-) for differences in distribution of blood groups. We performed multivariate analysis, controlling for maternal age and ethnicity, to evaluate association of ABO and Rh blood groups with maternal and perinatal outcomes in SARS-CoV-2(+) patients with adjusted odds ratios (aOR) and 95% confidence intervals (CI). MAIN OUTCOMES MEASURES: Medical morbidity: Symptomatic COVID-19 and medical complications. Obstetric outcomes: caesarean delivery, preterm deliveries, preterm premature rupture of membranes (PPROM), hemorrhagic events, pre-eclampsia, maternal and neonatal mortality, stillbirth. RESULTS: Differences were noted between blood types and Rh for age and ethnicity comparing SARS-CoV-2(+) and SARS-CoV-2(-) groups (p < 0.05). Among the SARS-CoV-2(+) cohort, the odds of symptomatic COVID-19 and obstetric hemorrhagic event were higher in Rh+ vs Rh- mothers (aOR 1.48, 95% CI 1.02-2.14, p = 0.037, and aOR 8.72, 95% CI 1.20-63.57, p = 0.033, respectively), and PPROM were higher among blood type A vs non-A mothers (aOR 2.06, 95% CI 1.01-4.18, p = 0.046). CONCLUSIONS: In SARS-CoV-2(+) pregnant women, Rh- status was associated with a lower risk of symptomatic COVID-19, while Rh+ and blood group A were associated with obstetric hemorrhage and PPROM, respectively.
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Antígenos de Grupos Sanguíneos , COVID-19 , Complicaciones Infecciosas del Embarazo , Nacimiento Prematuro , Femenino , Humanos , Recién Nacido , Transmisión Vertical de Enfermedad Infecciosa , Análisis Multivariante , Embarazo , Resultado del Embarazo/epidemiología , Estudios Prospectivos , SARS-CoV-2 , Mortinato/epidemiologíaRESUMEN
Hormonal changes during and after pregnancy are linked with modifications in the maternal microbiota. We describe the importance of the maternal microbiota in pregnancy and examine whether changes in maternal microbiotic composition at different body sites (gut, vagina, endometrium) are associated with pregnancy complications. We analyze the likely interactions between microbiota and the immune system. During pregnancy, the gastrointestinal (gut) microbiota undergoes profound changes that lead to an increase in lactic acid-producing bacteria and a reduction in butyrate-producing bacteria. The meaning of such changes needs clarification. Additionally, several studies have indicated a possible involvement of the maternal gut microbiota in autoimmune and lifelong diseases. The human vagina has its own microbiota, and changes in vaginal microbiota are related to several pregnancy-related complications. Recent studies show reduced lactobacilli, increased bacterial diversity, and low vaginal levels of beta-defensin 2 in women with preterm births. In contrast, early and healthy pregnancies are characterized by low diversity and low numbers of bacterial communities dominated by Lactobacillus. These observations suggest that early vaginal cultures that show an absence of Lactobacillus and polymicrobial vaginal colonization are risk factors for preterm birth. The endometrium is not a sterile site. Resident endometrial microbiota has only been defined recently. However, questions remain regarding the main components of the endometrial microbiota and their impact on the reproductive tract concerning both fertility and pregnancy outcomes. A classification based on endometrial bacterial patterns could help develop a microbiota-based diagnosis as well as personalized therapies for the prevention of obstetric complications and personalized treatments through nutritional, microbiotic, or pharmaceutical interventions.
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Microbioma Gastrointestinal/inmunología , Lactobacillus/inmunología , Nacimiento Prematuro , Vagina , Femenino , Humanos , Embarazo , Nacimiento Prematuro/diagnóstico , Nacimiento Prematuro/inmunología , Nacimiento Prematuro/microbiología , Nacimiento Prematuro/prevención & control , Vagina/inmunología , Vagina/microbiologíaRESUMEN
OBJETIVO: La dificultad para el diagnóstico y la variedad de manifestaciones clínicas que pueden determinar la elección del tratamiento del síndrome antifosfolípido (SAF) primario ha impulsado a la Sociedad Española de Reumatología (SER) en la elaboración de recomendaciones basadas en la mejor evidencia posible. Estas recomendaciones pueden servir de referencia para reumatólogos y otros profesionales implicados en el manejo de pacientes con SAF. MÉTODOS: Se creó un panel formado por cuatro reumatólogos, una ginecóloga y una hematóloga, expertos en SAF, previamente seleccionados mediante una convocatoria abierta o por méritos profesionales. Las fases del trabajo fueron: identificación de las áreas claves para la elaboración del documento, análisis y síntesis de la evidencia científica (utilizando los niveles de evidencia del Scottish Intercollegiate Guidelines Network [SIGN]) y formulación de recomendaciones a partir de esta evidencia y de técnicas de «evaluación formal» o «juicio razonado». RESULTADOS: Se han elaborado 46 recomendaciones que abordan cinco áreas principales: diagnóstico y evaluación, medidas de tromboprofilaxis primaria, tratamiento del SAF primario o tromboprofilaxis secundaria, tratamiento del SAF obstétrico y situaciones especiales. Se incluye también el papel de los nuevos anticoagulantes orales, el problema de las recurrencias o los principales factores de riesgo identificados en estos individuos. En este documento se reflejan las 21 primeras recomendaciones, referidas a las áreas de diagnóstico, evaluación y tratamiento del SAF primario. El documento contiene una tabla de recomendaciones y algoritmos de tratamiento. CONCLUSIONES: Se presentan las recomendaciones de la SER sobre SAF primario. Este documento corresponde a la parte I, relacionada con el diagnóstico, la evaluación y el tratamiento. Estas recomendaciones se consideran herramientas en la toma de decisiones para los clínicos, teniendo en consideración tanto la decisión del médico experto en SAF como la opinión compartida con el paciente. Se ha elaborado también una parte II, que aborda aspectos relacionados con el SAF obstétrico y situaciones especiales
OBJECTIVE: The difficulty in diagnosis and the spectrum of clinical manifestations that can determine the choice of treatment for primary antiphospholipid syndrome (APS) has fostered the development of recommendations by the Spanish Society of Rheumatology (SER), based on the best possible evidence. These recommendations can serve as a reference for rheumatologists and other specialists involved in the management of APS. METHODS: A panel of four rheumatologists, a gynaecologist and a haematologist with expertise in APS was created, previously selected by the SER through an open call or based on professional merits. The stages of the work were: identification of the key areas for drafting the document, analysis and synthesis of the scientific evidence (using the Scottish Intercollegiate Guidelines Network [SIGN] levels of evidence) and formulation of recommendations based on this evidence and formal assessment or reasoned judgement techniques (consensus techniques). RESULTS: 46 recommendations were drawn up, addressing five main areas: diagnosis and evaluation, measurement of primary thromboprophylaxis, treatment for APS or secondary thromboprophylaxis, treatment for obstetric APS and special situations. These recommendations also include the role of novel oral anticoagulants, the problem of recurrences or the key risk factors identified in these subjects. This document reflects the first 21, referring to the areas of: diagnosis, evaluation and treatment of primary APS. The document provides a table of recommendations and treatment algorithms. CONCLUSIONS: An update of the SER recommendations on APS is presented. This document corresponds to part I, related to diagnosis, evaluation and treatment. These recommendations are considered tools for decision-making for clinicians, taking into consideration both the decision of the physician experienced in APS and the patient. A part II has also been prepared, which addresses aspects related to obstetric SAF and special situations
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Humanos , Síndrome Antifosfolípido/diagnóstico , Síndrome Antifosfolípido/terapia , Sociedades Médicas/normas , Reumatología/normas , Síndrome Antifosfolípido/epidemiología , Síndrome Antifosfolípido/clasificación , Medicina Basada en la Evidencia/normas , ConsensoRESUMEN
OBJETIVO: La dificultad para el diagnóstico y la variedad de manifestaciones clínicas que pueden determinar la elección del tratamiento del síndrome antifosfolípido (SAF) primario ha impulsado a la Sociedad Española de Reumatología (SER) en la elaboración de recomendaciones basadas en la mejor evidencia posible. Estas recomendaciones pueden servir de referencia para reumatólogos y otros profesionales implicados en el manejo de pacientes con SAF. MÉTODOS: Se creó un panel formado por 4 reumatólogos, una ginecóloga y una hematóloga, expertos en SAF, previamente seleccionados mediante una convocatoria abierta o por méritos profesionales. Las fases del trabajo fueron: identificación de las áreas claves para la elaboración del documento, análisis y síntesis de la evidencia científica (utilizando los niveles de evidencia de SIGN, Scottish Intercollegiate Guidelines Network) y formulación de recomendaciones a partir de esta evidencia y de técnicas de «evaluación formal» o «juicio razonado». RESULTADOS: Se han elaborado 46 recomendaciones que abordan 5áreas principales: diagnóstico y evaluación, medidas de tromboprofilaxis primaria, tratamiento del SAF o tromboprofilaxis secundaria, tratamiento del síndrome antifosfolípido obstétrico y situaciones especiales. Está incluido también el papel de los nuevos anticoagulantes orales, el problema de las recurrencias o los principales factores de riesgo identificados en estos individuos. En este documento se reflejan las últimas 25, referidas a las áreas de: SAF obstétrico y situaciones especiales. El documento contiene una tabla de recomendaciones y algoritmos de tratamiento. CONCLUSIONES: Se presentan las recomendaciones de la SER sobre SAF. Este documento corresponde a la parte 2.ª relacionada con el SAF obstétrico y las situaciones especiales. Estas recomendaciones se consideran herramientas en la toma de decisiones para los clínicos, teniendo en consideración tanto la decisión del médico experto en SAF como la opinión compartida con el paciente. Se ha elaborado también una parte I que aborda aspectos relacionados con el diagnóstico, evaluación y tratamiento
OBJECTIVE: The difficulty in diagnosis and the spectrum of clinical manifestations that can determine the choice of treatment for antiphospholipid syndrome (APS) has fostered the development of recommendations by the Spanish Society of Rheumatology (SER), based on the best possible evidence. These recommendations can serve as a reference for rheumatologists and other specialists involved in the management of APS. METHODS: A panel of 4rheumatologists, a gynaecologist and a haematologist with expertise in APS was created, previously selected by the SER through an open call or based on professional merits. The stages of the work were: identification of the key areas for the document elaboration, analysis and synthesis of the scientific evidence (using the Scottish Intercollegiate Guidelines Network, SIGN levels of evidence) and formulation of recommendations based on this evidence and formal assessment or reasoned judgement techniques (consensus techniques). RESULTS: Forty-six recommendations were drawn up, addressing 5 main areas: diagnosis and evaluation, measurement of primary thromboprophylaxis, treatment for APS or secondary thromboprophylaxis, treatment for obstetric APS and special situations. These recommendations also include the role of novel oral anticoagulants, the problem of recurrences or the key risk factors identified in these subjects. This document reflects the last 25, referring to the areas of: obstetric APS and special situations. The document provides a table of recommendations and treatment algorithms. CONCLUSIONS: Update of SER recommendations on APS is presented. This document corresponds to part II, related to obstetric SAF and special situations. These recommendations are considered tools for decision-making for clinicians, taking into consideration both the decision of the physician experienced in APS and the patient. A part I has also been prepared, which addresses aspects related to diagnosis, evaluation and treatment
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Humanos , Femenino , Síndrome Antifosfolípido/epidemiología , Sociedades Médicas/normas , Medicina Basada en la Evidencia/normas , Complicaciones del Embarazo/epidemiología , Anticoagulantes/normas , Toma de Decisiones , Servicio de Ginecología y Obstetricia en Hospital/normas , Periodo PospartoRESUMEN
OBJECTIVE: The difficulty in diagnosis and the spectrum of clinical manifestations that can determine the choice of treatment for primary antiphospholipid syndrome (APS) has fostered the development of recommendations by the Spanish Society of Rheumatology (SER), based on the best possible evidence. These recommendations can serve as a reference for rheumatologists and other specialists involved in the management of APS. METHODS: A panel of four rheumatologists, a gynaecologist and a haematologist with expertise in APS was created, previously selected by the SER through an open call or based on professional merits. The stages of the work were: identification of the key areas for drafting the document, analysis and synthesis of the scientific evidence (using the Scottish Intercollegiate Guidelines Network [SIGN] levels of evidence) and formulation of recommendations based on this evidence and formal assessment or reasoned judgement techniques (consensus techniques). RESULTS: 46 recommendations were drawn up, addressing five main areas: diagnosis and evaluation, measurement of primary thromboprophylaxis, treatment for APS or secondary thromboprophylaxis, treatment for obstetric APS and special situations. These recommendations also include the role of novel oral anticoagulants, the problem of recurrences or the key risk factors identified in these subjects. This document reflects the first 21, referring to the areas of: diagnosis, evaluation and treatment of primary APS. The document provides a table of recommendations and treatment algorithms. CONCLUSIONS: An update of the SER recommendations on APS is presented. This document corresponds to partI, related to diagnosis, evaluation and treatment. These recommendations are considered tools for decision-making for clinicians, taking into consideration both the decision of the physician experienced in APS and the patient. A partII has also been prepared, which addresses aspects related to obstetric SAF and special situations.
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Síndrome Antifosfolípido/diagnóstico , Síndrome Antifosfolípido/terapia , Síndrome Antifosfolípido/complicaciones , Humanos , Sociedades Médicas , EspañaRESUMEN
OBJECTIVE: The difficulty in diagnosis and the spectrum of clinical manifestations that can determine the choice of treatment for antiphospholipid syndrome (APS) has fostered the development of recommendations by the Spanish Society of Rheumatology (SER), based on the best possible evidence. These recommendations can serve as a reference for rheumatologists and other specialists involved in the management of APS. METHODS: A panel of 4rheumatologists, a gynaecologist and a haematologist with expertise in APS was created, previously selected by the SER through an open call or based on professional merits. The stages of the work were: identification of the key areas for the document elaboration, analysis and synthesis of the scientific evidence (using the Scottish Intercollegiate Guidelines Network, SIGN levels of evidence) and formulation of recommendations based on this evidence and formal assessment or reasoned judgement techniques (consensus techniques). RESULTS: Forty-six recommendations were drawn up, addressing 5main areas: diagnosis and evaluation, measurement of primary thromboprophylaxis, treatment for APS or secondary thromboprophylaxis, treatment for obstetric APS and special situations. These recommendations also include the role of novel oral anticoagulants, the problem of recurrences or the key risk factors identified in these subjects. This document reflects the last 25, referring to the areas of: obstetric APS and special situations. The document provides a table of recommendations and treatment algorithms. CONCLUSIONS: Update of SER recommendations on APS is presented. This document corresponds to part II, related to obstetric SAF and special situations. These recommendations are considered tools for decision-making for clinicians, taking into consideration both the decision of the physician experienced in APS and the patient. A part I has also been prepared, which addresses aspects related to diagnosis, evaluation and treatment.
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Síndrome Antifosfolípido/diagnóstico , Síndrome Antifosfolípido/terapia , Complicaciones del Embarazo/diagnóstico , Complicaciones del Embarazo/terapia , Algoritmos , Femenino , Humanos , EmbarazoRESUMEN
Online patient registries are used to collect data on clinical conditions with rare occurrence or unclear diagnostic and management practices. The success of these registries depends on clear definition of goals, correct identification of patient population/inclusion criteria, availability of appropriate setup and maintenance tools, and the quality of dissemination. The Scientific and Standardization Committee (SSC) for Women's Health Issues in Thrombosis and Hemostasis, one of 20 committees of the International Society on Thrombosis and Haemostasis (ISTH) has developed 6 registries for women's bleeding and thrombotic conditions over the past 2 years and are currently in various stages of progress. Here, we provide information about these registries, including rationale, objectives, and methods for data collection. The aim is to enhance worldwide participation and thus promote the success of these registries. We used ISTH REDCap, a mature and secure Web application for building and managing online surveys and databases, and the ISTH advertising platform to maximize participation. Registries (links and project details available on ISTH and Women's SSC Web sites) include: (1) WiTEAM, project on thrombophilia and placenta-mediated obstetric complications; (2) a registry for disseminated intravascular coagulation in pregnancy; (3) severe congenital protein C deficiency-an obstetric study; (4) obstetric and gynecologic outcomes of women with platelet function disorders; (5) thrombolysis and invasive treatments for massive pregnancy-related pulmonary embolism; (6) pregnancy and exposure to direct oral anticoagulants. The ISTH promotes online registries on women's issues to enhance understanding of current practices, identify knowledge gaps, promote research, and ultimately improve patient safety and quality of life.
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Objetivo: conocer la prevalencia de trombofilia en trombosis gestacional y complicaciones vasulares gestacionales en nuestro entorno y el manejo de las mismas. Material y métodos: estudio prospectivo y observacional en el que se incluyeron cuatro cohortes: trombosis, profilaxis de trombosis, complicaciones vasulares gestacionales, profilaxis de complicaciones vasulares gestacionales. Se registraron 1.032 episodios, de los cuales se incluyeron 994 en el análisis final. Resultados: la distribución de episodios fue: 5,5% trombosis, 30,2% profilaxis de trombosis, 35,7% complicaciones vasulares gestacionales y 24,9% profilaxis de complicaciones vasulares gestacionales. Las pérdidas gestacionales fueron la complicación más frecuente. Se realizó estudio de trombofilia en 82,6% de complicaciones vasulares gestacionales y 70,2% de trombosis. Los resultados fueron positivos en el 47% de trombosis y en 21% de complicaciones vasulares gestacionales. Los defectos más comunes en complicaciones vasulares gestacionales fueron la elevación del factor VIII, la presencia de anticuerpos antifosfolípidos y la mutación F12C46T en homocigosis. Se empleó tratamiento antitrombótico en el 85% de profilaxis de trombosis y en el 77% de profilaxis de complicaciones vasulares gestacionales. La tromboprofilaxis de complicaciones vasulares gestacionales no se relacionó con una mejora en el resultado de la gestación. Conclusiones: se realizaron estudios de trombofilia a la mayoría de las pacientes, con resultados diferentes en trombosis y complicaciones vasulares gestacionales. Se empleó tromboprofilaxis en más del 70% de las pacientes. La profilaxis farmacológica de complicaciones vasulares gestacionales no aportó beneficio significativo. Serían necesarios estudios futuros para confirmar nuestros resultados (AU)
Objective: The main objectives were to establish the prevalence of thrombophilia in pregnancy-related thrombosis and vascular placental complications and to evaluate the clinical management of these complications. Materials and methods: Multicenter, prospective and observational study. We analysed 4 patient cohorts: thrombosis, thrombosis prophylaxis, vascular placental complications, vascular placental complications prophylaxis. A total of 1032 episodes were registeredand 994 were included in the final analysis. Results: The distribution of the episodes was: 5.5% thrombosis, 30.2% thrombosis prophylaxis, 35.7% vascular placental complications and 24.9% vascular placental complications prophylaxis. Pregnancy loss was the most frequent complication registered. Thrombophilia studies were made in 82.6% patients in vascular placental complications cohort and in 70.2% of thrombosis patients. Positive results were obtained in 47% of patients in thrombosis group and in 21% of patients with vascular placental complications. In this group the most common defects found were high levels of FVIII, positive antiphospholipid antibodies and homocigosity for F12C46T polymorphism. Antithrombotic treatment was used in 85% of thrombosis prophylaxis episodes and in 77% of vascular placental complications prophylaxis episodes. Pharmacologic prophylaxis was not related with a better pregnancy outcome in vascular placental complications prophylaxis group. Conclusions: Thrombophilia studies were made to most patients in this registry. Results were different in patients with thrombosis and vascular placental complications. Most patients in vascular placental complications prophylaxis group with or without thrombophilia recieved LMWH +/- aspirin, but we did not find a benefit of these treatments. Further studies with more patients will be needed to confirm our findings (AU)
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Humanos , Femenino , Embarazo , Trombosis/complicaciones , Enfermedades Vasculares/complicaciones , Aborto Habitual/epidemiología , Heparina de Bajo-Peso-Molecular/uso terapéutico , Complicaciones Cardiovasculares del Embarazo/epidemiología , Estudios Prospectivos , Estudios de Cohortes , Fibrinolíticos/uso terapéutico , Trombofilia/diagnóstico , Trombofilia/terapia , Profilaxis Antibiótica/métodosRESUMEN
OBJECTIVE: Heparin-induced thrombocytopenia (HIT) is a rare but severe prothrombotic disorder of heparin treatment that leads to a decline in platelet count and thrombotic complications. If HIT is suspected, then heparin should be stopped and an alternative anticoagulant started. Fondaparinux is a factor Xa-inhibitor that is not FDA-approved for this condition, but preliminary experience in HIT patients has been reported in the literature. The present study describes an experience of anticoagulation management with fondaparinux in postoperative cardiac surgery patients. DESIGN: Retrospective study. SETTING: Tertiary hospital. PARTICIPANTS: Patients who had undergone cardiac surgery from October 2009 to June 2012. INTERVENTIONS: After HIT was suspected clinically, PaGIA and ELISA test were performed in all patients to diagnose HIT. In the patients included, anticoagulation was managed with a low dose of fondaparinux and daily monitoring of platelet count and anti-Xa level. MEASUREMENTS AND MAIN RESULTS: Of a total of 1,338 postoperative cardiac surgery patients, 15 patients were included (1.1%). Twelve of the 15 patients with HIT presented with renal failure and were under continuous renal replacement therapy. Two major bleeding events occurred during fondaparinux treatment, although platelet count and anti-Xa activity remained within the normal range. No thrombotic episodes were diagnosed. CONCLUSION: With daily monitoring of anti-Xa activity, fondaparinux appeared to be a good alternative to heparin in the study group; however, randomized clinical trials are needed to establish the safety and efficacy of this drug in critically ill, previously HIT patients.