Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial

Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation

Controle público e eqüidade no acesso a hospitais sob gestão pública não estatal Public control and equity of access to hospitals under non-State public administration

OBJETIVO: Analisar as organizações sociais de saúde à luz do controle público e da garantia da eqüidade no acesso aos serviços de saúde. MÉTODOS: Utilizou-se a técnica de estudo de caso e foram selecionadas duas organizações sociais de saúde na região metropolitana de São Paulo. As categorias analíticas foram eqüidade no acesso e controle público, baseando-se em entrevistas com informantes-chave e relatórios técnico-administrativos. RESULTADOS: Observou-se que financiamento global e o controle administrativo das organizações sociais de saúde são atribuições do gestor estadual. A presença do gestor local é importante para a garantia da eqüidade no acesso, sendo que o controle público se expressa por ações fiscalizadoras mediante procedimentos contábil-financeiros. CONCLUSÕES: A eqüidade no acesso e o controle público não são contemplados na gestão dessas organizações. A questão central encontra-se na capacidade do poder público se fazer presente na implementação dessa modalidade no âmbito local, garantido a eqüidade no acesso e contemplando o controle público.<br>OBJECTIVE: To analyze social health organizations in the light of public control and the guarantee of equity of access to health services. METHODS: Utilizing the case study technique, two social health organizations in the metropolitan region of São Paulo were selected. The analytical categories were equity of access and public control, and these were based on interviews with key informants and technical-administrative reports. RESULTS: It was observed that the overall funding and administrative control of the social health organizations are functions of the state administrator. The presence of a local administrator is important for ensuring equity of access. Public control is expressed through supervisory actions, by means of accounting and financial procedures. CONCLUSIONS: Equity of access and public control are not taken into consideration in the administration of these organizations. The central question lies in the capacity of the public authorities to have a presence in implementing this model at the local level, thereby ensuring equity of access and taking public control into consideration

Autonomia outorgada e apropriação do trabalho Granted autonomy and work appropriation

O objetivo deste trabalho é discutir o significado da autonomia outorgada enquanto corolário organizacional de uma demanda de mobilização subjetiva. O trabalho vive a contradição entre a apologia da autonomia e uma organização do trabalho crescentemente normalizada, onde ser autônomo é a regra. O conceito de autonomia no trabalho lança mão de duas questões: a dimensão operacional e a dimensão identitária. A transformação do trabalho em um bem cuja possessão exige sacrifícios e a transformação do emprego em um privilégio culminam em uma sujeição da própria pessoa do trabalhador, sem se colocar realmente a questão da reapropriação do trabalho, o que a priori acompanharia a autonomia no trabalho. A questão central, no entanto, não pode se diluir neste paradoxo entre autonomia real e autonomia outorgada: a busca de autonomia situa-se fora da lógica econômica e dentro de uma lógica de valores e de conquista de sentido, enquanto que a autonomia outorgada inscreve-se em uma lógica instrumental.<br>This work is aimed at debating the meaning of granted autonomy as the organizational corollary of a subjective mobilization demand. Labor in undergoing the contradiction between the eulogy to autonomy and an increasing normalized labor organization, where being autonomous is the rule. The concept of labor autonomy resorts to two issues: the operational dimension and the identity dimension. The transformation of labor into a good whose possession demands sacrifices and the transformation of the job into a privilege culminate at subjection of the worker's very person, without really raising the issue of labor re-appropriation, which a priori follows labor autonomy. The core issue, however, cannot be diluted into this paradox between real autonomy and granted autonomy: the search for autonomy is placed out of the economic logic and within a logic of values and achievement of meaning, while granted autonomy is part of an instrumental logic

Famílias cuidadoras de pessoa idosa: relação com instituições sociais e de saúde

Trata-se de pesquisa de cunho qualitativo que teve como objetivo compreender a relação de famílias de classe popular cuidadoras de idoso fragilizado com as instituições sociais e de saúde. A metodologia utilizada é o Estudo de Caso do Tipo Etnográfico. A coleta de dados foi realizada com Observação Participante e Entrevista com quatro famílias. Através da análise de conteúdo foram identificados três temas: o suporte social, a relação com os serviços de saúde, a relação com a unidade sanitária local. As famílias destacam que o acesso aos serviços de saúde é sofrível e ressaltam a urgência em solidificar o Sistema Único de Saúde, em busca da concretização dos seus princípios