Shakur Haleema, Fawole Bukola, Kuti Modupe, Olayemi Oladapo, Bello Adenike, Ogunbode Olayinka, Kotila Taiwo, Aimakhu Chris O, Huque Sumaya, Gregg Meghann, Roberts Ian
Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, UK.
Department of Obstetrics & Gynaecology National Institute of Maternal and Child Health, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Wellcome Open Res. 2016 Dec 16;1:31. doi: 10.12688/wellcomeopenres.10383.1.
: Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. . Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo. Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. The trial was registered: ClinicalTrials.gov, Identifier NCT00872469 https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190 http://www.isrctn.com/ISRCTN76912190 (Registration date: 22/03/2012).
产后出血（PPH）是孕产妇死亡的主要原因。氨甲环酸有可能减少出血，一项关于其对PPH女性孕产妇健康结局影响的大型随机对照试验（WOMAN试验）正在进行中。我们将在WOMAN试验的一部分参与者中研究氨甲环酸对纤维蛋白溶解和凝血的影响。临床诊断为阴道分娩或剖宫产术后原发性PPH的成年女性有资格纳入WOMAN试验。在一部分试验参与者中，将在基线以及第一剂氨甲环酸或匹配安慰剂给药后30分钟采集血样。我们的主要目标是评估氨甲环酸对纤维蛋白溶解的影响。将通过测量D-二聚体和旋转血栓弹力图（ROTEM）来评估纤维蛋白溶解。次要结局指标为国际标准化比值（INR）、凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原、血红蛋白和血小板。我们的目标是纳入来自尼日利亚伊巴丹大学学院医院的约180名女性。这项对WOMAN试验参与者的子研究应能提供氨甲环酸在产后出血女性中的作用机制信息。我们展示了试验方案和统计分析计划。试验方案在患者招募开始前已注册。统计分析计划在揭盲前完成。该试验已注册：ClinicalTrials.gov，标识符NCT00872469 https://clinicaltrials.gov/ct2/show/NCT00872469；ISRCTN注册库，标识符ISRCTN76912190 http://www.isrctn.com/ISRCTN76912190（注册日期：2012年3月22日）。
