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Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial

Background: Postpartum haemorrhage (PPH) is responsible for over 50,000 maternal deaths every year. Most of these deaths are in low- and middle-income countries. Tranexamic acid (TXA) reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. TXA decreases surgical bleeding and re...

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Autores principales: Collier, Tim, Shakur-Still, Haleema, Roberts, Ian, Balogun, Eni, Olayemi, Oladapo, Bello, Folasade Adenike, Chaudhri, Rizwana, Muganyizi, Projestine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10471795/
https://www.ncbi.nlm.nih.gov/pubmed/37664793
http://dx.doi.org/10.12688/gatesopenres.14529.2
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author Collier, Tim
Shakur-Still, Haleema
Roberts, Ian
Balogun, Eni
Olayemi, Oladapo
Bello, Folasade Adenike
Chaudhri, Rizwana
Muganyizi, Projestine
author_facet Collier, Tim
Shakur-Still, Haleema
Roberts, Ian
Balogun, Eni
Olayemi, Oladapo
Bello, Folasade Adenike
Chaudhri, Rizwana
Muganyizi, Projestine
author_sort Collier, Tim
collection PubMed
description Background: Postpartum haemorrhage (PPH) is responsible for over 50,000 maternal deaths every year. Most of these deaths are in low- and middle-income countries. Tranexamic acid (TXA) reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. TXA decreases surgical bleeding and reduces deaths from bleeding after traumatic injury. When given within three hours of birth, TXA reduces deaths from bleeding in women with PPH. However, for many women, treatment of PPH is too late to prevent death. World-wide, over one-third of pregnant women are anaemic and many are severely anaemic. These women have an increased risk of PPH and are more likely to die if PPH occurs. There is an urgent need to identify ways to prevent severe postpartum bleeding in anaemic women. The WOMAN-2 trial will quantify the effects of TXA on postpartum bleeding in women with anaemia. Results: This statistical analysis plan (version 1.0; dated 22 February 2023) has been written based on information in the WOMAN-2 Trial protocol version 2.0, dated 30 June 2022. The primary outcome of the WOMAN-2 trial is the proportion of women with a clinical diagnosis of primary PPH. Secondary outcomes are maternal blood loss and its consequences (estimated blood loss, haemoglobin, haemodynamic instability, blood transfusion, signs of shock, use of interventions to control bleeding); maternal health and wellbeing (fatigue, headache, dizziness, palpitations, breathlessness, exercise tolerance, ability to care for her baby, health related quality of life, breastfeeding); and other health outcomes (deaths, vascular occlusive events, organ dysfunction, sepsis, side effects, time spent in higher level facility, length of hospital stay, and status of the baby). Conclusions: WOMAN-2 will provide reliable evidence about the effects of TXA in women with anaemia. Registration: WOMAN-2 was prospectively registered at the International Standard Randomised Controlled Trials registry ( ISRCTN62396133) on 07/12/2017 and ClinicalTrials.gov on 23/03/2018 ( NCT03475342).
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spelling pubmed-104717952023-09-02 Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial Collier, Tim Shakur-Still, Haleema Roberts, Ian Balogun, Eni Olayemi, Oladapo Bello, Folasade Adenike Chaudhri, Rizwana Muganyizi, Projestine Gates Open Res Study Protocol Background: Postpartum haemorrhage (PPH) is responsible for over 50,000 maternal deaths every year. Most of these deaths are in low- and middle-income countries. Tranexamic acid (TXA) reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. TXA decreases surgical bleeding and reduces deaths from bleeding after traumatic injury. When given within three hours of birth, TXA reduces deaths from bleeding in women with PPH. However, for many women, treatment of PPH is too late to prevent death. World-wide, over one-third of pregnant women are anaemic and many are severely anaemic. These women have an increased risk of PPH and are more likely to die if PPH occurs. There is an urgent need to identify ways to prevent severe postpartum bleeding in anaemic women. The WOMAN-2 trial will quantify the effects of TXA on postpartum bleeding in women with anaemia. Results: This statistical analysis plan (version 1.0; dated 22 February 2023) has been written based on information in the WOMAN-2 Trial protocol version 2.0, dated 30 June 2022. The primary outcome of the WOMAN-2 trial is the proportion of women with a clinical diagnosis of primary PPH. Secondary outcomes are maternal blood loss and its consequences (estimated blood loss, haemoglobin, haemodynamic instability, blood transfusion, signs of shock, use of interventions to control bleeding); maternal health and wellbeing (fatigue, headache, dizziness, palpitations, breathlessness, exercise tolerance, ability to care for her baby, health related quality of life, breastfeeding); and other health outcomes (deaths, vascular occlusive events, organ dysfunction, sepsis, side effects, time spent in higher level facility, length of hospital stay, and status of the baby). Conclusions: WOMAN-2 will provide reliable evidence about the effects of TXA in women with anaemia. Registration: WOMAN-2 was prospectively registered at the International Standard Randomised Controlled Trials registry ( ISRCTN62396133) on 07/12/2017 and ClinicalTrials.gov on 23/03/2018 ( NCT03475342). F1000 Research Limited 2023-08-03 /pmc/articles/PMC10471795/ /pubmed/37664793 http://dx.doi.org/10.12688/gatesopenres.14529.2 Text en Copyright: © 2023 Collier T et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Collier, Tim
Shakur-Still, Haleema
Roberts, Ian
Balogun, Eni
Olayemi, Oladapo
Bello, Folasade Adenike
Chaudhri, Rizwana
Muganyizi, Projestine
Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial
title Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial
title_full Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial
title_fullStr Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial
title_full_unstemmed Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial
title_short Tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  Statistical analysis plan for the WOMAN-2 trial: an international, randomised, placebo-controlled trial
title_sort tranexamic acid for the prevention of postpartum bleeding in women with anaemia:  statistical analysis plan for the woman-2 trial: an international, randomised, placebo-controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10471795/
https://www.ncbi.nlm.nih.gov/pubmed/37664793
http://dx.doi.org/10.12688/gatesopenres.14529.2
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