Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial

: 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...

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Published in:	Wellcome open research Vol. 1; p. 31
Main Authors:	Shakur, Haleema, Fawole, Bukola, Kuti, Modupe, Olayemi, Oladapo, Bello, Adenike, Ogunbode, Olayinka, Kotila, Taiwo, Aimakhu, Chris O, Huque, Sumaya, Gregg, Meghann, Roberts, Ian
Format:	Journal Article
Language:	English
Published:	England Wellcome Trust Limited 16-12-2016 F1000Research Wellcome
Subjects:	Acids Anemia Antifibrinolytic agents Blood tests Childrens health Clinical trials Drug dosages Gynecology Hematology Maternal & child health Medicine Mortality Obstetrics Pregnancy, Labor, Delivery & Postpartum Care Quality control Statistical analysis Study Protocol Trauma Womens health United Kingdom > UK Nigeria Germany D-dimer Postpartum Haemorrhage Tranexamic Acid Fibrinogen ROTEM
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Summary:	: 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).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Haleema Shakur and Ian Roberts conceived the study and contributed to the statistical analysis plan and writing of the manuscript; Haleema Shakur led the protocol development and is responsible for overseeing the trial and data management; Bukola Fawole contributed to protocol development and has overall responsibility for the study at the trial site and review of the manuscript; Oladapo Olayemi contributed to protocol development and is the site principal investigator for WOMAN trial and review of the manuscript; Modupe Kuti contributed to the protocol development and was responsible for overseeing laboratory tests, laboratory standard operating procedures and staff training and review of the manuscript; Adenike Bello contributed to protocol development and was responsible for data transfer and review of the manuscript; Olayinka Ogunbode contributed to the protocol development, development of the Standard Operating Procedures and was responsible for participant recruitment and review of the manuscript; Chris Aimakhu contributed to the protocol development and was responsible for participant recruitment and review of the manuscript; Taiwo Kotila contributed to the protocol development and was responsible for routine laboratory tests and review of the manuscript; Meghann Gregg led the development of the statistical analysis plan and review of the manuscript; Sumaya Haque contributed to the statistical analysis plan. Competing interests: No competing interests were disclosed.
ISSN:	2398-502X 2398-502X
DOI:	10.12688/wellcomeopenres.10383.1