Tranexamic acid for the treatment of postpartum haemorrhage: An international randomised, double blind, placebo controlled trial - WOMAN: The World Maternal Antifibrinolytic Trial (Version 1)

ondon School Of Hygiene and Tropical Medicine0 个研究点目标入组 20,060 人开始时间: 2010年12月8日最近更新: 2019年6月30日

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•All legally adult (16 years old and above in the UK) women with clinically diagnosed postpartum haemorrhage following vaginal delivery or caesarean section. Clinical diagnosis of postpartum haemorrhage may be based on an estimated blood loss of:
•- greater than 500mls blood loss after vaginal delivery OR
•- greater than 1000mls blood loss after ceasarean section, OR
•- any amount of blood loss sufficient to compromise the haemodynamic status of the woman.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•The fundamental eligibility criterion is the responsible clinician’s ‘uncertainty’ as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage. Women for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Women for whom there is considered to be a clear contraindication for antifibrinolytic therapy (as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic, all these women are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria.

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ondon School Of Hygiene and Tropical Medicine