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English to Spanish: CLINICAL TRIAL PROTOCOL (WOMAN) General field: Medical
Source text - English BACKGROUND: Each year, worldwide about 530,000 women die from causes related to pregnancy and childbirth. Almost all (99%) of the deaths are in low and middle income countries. Obstetric haemorrhage is the leading cause of maternal mortality accounting for between one quarter and one third of deaths, most of which occur in the postpartum period. About 14 million mothers develop postpartum haemorrhage (PPH) each year and about 2% of them will die, with an average interval from onset to death of about 2 to 4 hours. Obstetric haemorrhage is also an important cause of maternal mortality in high income countries where it accounts for about 13% of maternal deaths. Systemic antifibrinolytic agents are widely used in surgery to prevent clot breakdown (fibrinolysis) in order to reduce surgical blood loss. A systematic review of randomised controlled trials of antifibrinolytic agents in surgical patients identified 211 randomised controlled trials including 20,781 randomised participants. The results show that tranexamic acid (TXA) reduces the risk of blood transfusion by a relative 39% (RR=0.61, 95%CI 0.54 to 0.69). TXA reduces transfused volume by 1.1 units (95%CI 0.64 to 1.59). TXA also reduces the need for re-operation due to bleeding (RR= 0.67, 95%CI 0.41 to 1.09). There was no evidence of an increased risk of thrombotic events.
TXA significantly reduces uterine blood loss in women with menorrhagia and is “recommended for consideration” as a treatment in intractable postpartum haemorrhage in the UK. However, at present there is little reliable evidence from randomised trials on the effectiveness of TXA in the treatment of PPH. A systematic review of randomised trials of TXA in PPH conducted by the applicants identified three trials of the prophylactic use of TXA, including a total of 460 participants. Although there was a significant reduction in average postpartum blood loss in women treated with TXA, the quality of the trials was poor. None had adequate allocation concealment and even in aggregate the trials were too small to assess the effects of TXA on the clinically important end points of mortality, hysterectomy and thrombotic side effects. The most recently updated PPH treatment guidelines prepared by the World Health Organization (WHO) state that TXA may be used in the treatment of PPH if other measures fail, but points out that the quality of evidence on which this recommendation is based is low and recommends that further clinical trials of TXA in PPH are conducted.
Translation - Spanish CONTEXTO: cada año mueren 530.000 mujeres en todo el mundo por causas relacionadas con el embarazo y el parto. Prácticamente todas las muertes (99%) se producen en países de renta baja y media. Las hemorragias obstétricas constituyen la causa principal de mortalidad materna, son responsables de un cuarto a un tercio de las muertes, la mayoría de las cuales se producen en el periodo posparto. Aproximadamente 14 millones de madres desarrollan una hemorragia posparto (HPP) cada año, lo que producirá la muerte a casi un 2% de ellas, con un intervalo medio del inicio al fallecimiento de 2 a 4 horas. La hemorragia obstétrica también es una causa importante de mortalidad en países de rentas altas, donde representa un 13% de las muertes maternas. Los agentes antifibrinolíticos se usan ampliamente en cirugía para evitar la degradación del coágulo (fibrinolisis) con el fin de reducir la pérdida de sangre durante la intervención. Una revisión sistemática de ensayos aleatorios controlados de compuestos antifibrinolíticos en pacientes de cirugía identificó 211 estudios con una muestra total de 20.781 participantes aleatorios. Los resultados demuestran que el ácido tranexámico (ATX) reduce la necesidad de transfusión sanguínea en un 39% (RR=0,61, IC95% de 0,54 a 0,69). El ATX reduce el volumen de transfusión en 1,1 unidades (IC95%: 0,64 a 1,59) y también reduce la necesidad de reintervención a causa del sangrado (RR= 0,67, IC95%: 0,41 a 1,09). No se encontraron indicios de aumento del riesgo de eventos trombóticos.
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Years of experience: 30. Registered at ProZ.com: May 2010.
