Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial
Summary Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant...
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creator | Fawole, Bukola Qureshi, Zahida Abdulkadir, Abdulfetah Afsana, Kaosar Lumbiganon, Pisake Piaggio, Gilda Elbourne, Diana Gilliam, Catherine Kostrov, Sergey Godec, Tom Regmi, Mohan Odekunle, Olufemi Offiah, Ifeoma Akpan, Ubong Omoronyia, Ezukwa Aimakhu, Chris Akinsanya, Olufemi Adeyemi, Oluwaseun Aboyeji, Abiodun Adewale, Adebayo Olaomo, Noah Ogudu, John Onafowokan, Olatunde Isah, David Salau, Olaide Habeebu-Adeyemi, Fatimah Idris, Hadiza Opreh, Owigho Udonwa, Sophia Ifemeje, Arafat Adamu, Yusuf Baffah Adekola-Oni, Grace Kua, Paul Awoleke, Jacob Sulayman, Hajaratu Ameh, Nkeiruka Adelodun, Affiss Adeniji, Adetunji Oyelade, Folasade Henry, Palmer Loto, Olabisi Adeniyi, Augustine Ikpen, Akpojaro Nwosu, Ikemefuna Abubakar, Sola Jabeen, Kiran Asmat, Raheela Bukhari, Syeda Rabia Gul, Fouzia Sherin, Akhtar Ain, Qurratul Shaheen, Uzma Rizvi, Shabana Manzoor, Sofia Tasnim, Nasira Bashir, Lubna Iqbal, Saima Dojki, Samina Aslam, Summera Mustafa, Nilofar Waqar, Fareesa Nuulu, Nakirigya Bwotya, Rose Ngonzi, Joseph Innocent, Nkonwa Anitah, Kusasira Meregurwa, Grace Oyiengo, Vincent Wangui, Rose Nassir, Faiza Osoti, Alfred Ongwae, Veronicah Wanjohi, Victor Ashu, Alice Simo, André Tchana, Mesack Umbeli, Taha Abdelrahiem, Somia Awadalla, Khidir Abdullahi, Hala Hinshaw, Kim Ayuk, Paul Wilkins, Joanne Tower, Clare Allibone, Alysha Mayumba, Khadija Agrawal, Ajay Yadav, Punita Silwimba, Willies Lubeya, Mwansa Ketty Kruja, Aferdita Brahimaj, Besnik Tola, Armida Musau, Badibanga Kalyana, Herman Jason, Nzanzu Kikuhe Missumba, Willis Begum, Nazneen Paul, Shrodha Basta, Wafaa |
description | Summary Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov , number NCT00872469 ; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes |
doi_str_mv | 10.1016/S0140-6736(17)30638-4 |
format | Article |
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Qureshi, Zahida ; Abdulkadir, Abdulfetah ; Afsana, Kaosar ; Lumbiganon, Pisake ; Piaggio, Gilda ; Elbourne, Diana ; Gilliam, Catherine ; Kostrov, Sergey ; Godec, Tom ; Regmi, Mohan ; Odekunle, Olufemi ; Offiah, Ifeoma ; Akpan, Ubong ; Omoronyia, Ezukwa ; Aimakhu, Chris ; Akinsanya, Olufemi ; Adeyemi, Oluwaseun ; Aboyeji, Abiodun ; Adewale, Adebayo ; Olaomo, Noah ; Ogudu, John ; Onafowokan, Olatunde ; Isah, David ; Salau, Olaide ; Habeebu-Adeyemi, Fatimah ; Idris, Hadiza ; Opreh, Owigho ; Udonwa, Sophia ; Ifemeje, Arafat ; Adamu, Yusuf Baffah ; Adekola-Oni, Grace ; Kua, Paul ; Awoleke, Jacob ; Sulayman, Hajaratu ; Ameh, Nkeiruka ; Adelodun, Affiss ; Adeniji, Adetunji ; Oyelade, Folasade ; Henry, Palmer ; Loto, Olabisi ; Adeniyi, Augustine ; Ikpen, Akpojaro ; Nwosu, Ikemefuna ; Abubakar, Sola ; Jabeen, Kiran ; Asmat, Raheela ; Bukhari, Syeda Rabia ; Gul, Fouzia ; Sherin, Akhtar ; Ain, Qurratul ; Shaheen, Uzma ; Rizvi, Shabana ; Manzoor, Sofia ; Tasnim, Nasira ; Bashir, Lubna ; Iqbal, Saima ; Dojki, Samina ; Aslam, Summera ; Mustafa, Nilofar ; Waqar, Fareesa ; Nuulu, Nakirigya ; Bwotya, Rose ; Ngonzi, Joseph ; Innocent, Nkonwa ; Anitah, Kusasira ; Meregurwa, Grace ; Oyiengo, Vincent ; Wangui, Rose ; Nassir, Faiza ; Osoti, Alfred ; Ongwae, Veronicah ; Wanjohi, Victor ; Ashu, Alice ; Simo, André ; Tchana, Mesack ; Umbeli, Taha ; Abdelrahiem, Somia ; Awadalla, Khidir ; Abdullahi, Hala ; Hinshaw, Kim ; Ayuk, Paul ; Wilkins, Joanne ; Tower, Clare ; Allibone, Alysha ; Mayumba, Khadija ; Agrawal, Ajay ; Yadav, Punita ; Silwimba, Willies ; Lubeya, Mwansa Ketty ; Kruja, Aferdita ; Brahimaj, Besnik ; Tola, Armida ; Musau, Badibanga ; Kalyana, Herman ; Jason, Nzanzu Kikuhe ; Missumba, Willis ; Begum, Nazneen ; Paul, Shrodha ; Basta, Wafaa</creator><creatorcontrib>Fawole, Bukola ; Qureshi, Zahida ; Abdulkadir, Abdulfetah ; Afsana, Kaosar ; Lumbiganon, Pisake ; Piaggio, Gilda ; Elbourne, Diana ; Gilliam, Catherine ; Kostrov, Sergey ; Godec, Tom ; Regmi, Mohan ; Odekunle, Olufemi ; Offiah, Ifeoma ; Akpan, Ubong ; Omoronyia, Ezukwa ; Aimakhu, Chris ; Akinsanya, Olufemi ; Adeyemi, Oluwaseun ; Aboyeji, Abiodun ; Adewale, Adebayo ; Olaomo, Noah ; Ogudu, John ; Onafowokan, Olatunde ; Isah, David ; Salau, Olaide ; Habeebu-Adeyemi, Fatimah ; Idris, Hadiza ; Opreh, Owigho ; Udonwa, Sophia ; Ifemeje, Arafat ; Adamu, Yusuf Baffah ; Adekola-Oni, Grace ; Kua, Paul ; Awoleke, Jacob ; Sulayman, Hajaratu ; Ameh, Nkeiruka ; Adelodun, Affiss ; Adeniji, Adetunji ; Oyelade, Folasade ; Henry, Palmer ; Loto, Olabisi ; Adeniyi, Augustine ; Ikpen, Akpojaro ; Nwosu, Ikemefuna ; Abubakar, Sola ; Jabeen, Kiran ; Asmat, Raheela ; Bukhari, Syeda Rabia ; Gul, Fouzia ; Sherin, Akhtar ; Ain, Qurratul ; Shaheen, Uzma ; Rizvi, Shabana ; Manzoor, Sofia ; Tasnim, Nasira ; Bashir, Lubna ; Iqbal, Saima ; Dojki, Samina ; Aslam, Summera ; Mustafa, Nilofar ; Waqar, Fareesa ; Nuulu, Nakirigya ; Bwotya, Rose ; Ngonzi, Joseph ; Innocent, Nkonwa ; Anitah, Kusasira ; Meregurwa, Grace ; Oyiengo, Vincent ; Wangui, Rose ; Nassir, Faiza ; Osoti, Alfred ; Ongwae, Veronicah ; Wanjohi, Victor ; Ashu, Alice ; Simo, André ; Tchana, Mesack ; Umbeli, Taha ; Abdelrahiem, Somia ; Awadalla, Khidir ; Abdullahi, Hala ; Hinshaw, Kim ; Ayuk, Paul ; Wilkins, Joanne ; Tower, Clare ; Allibone, Alysha ; Mayumba, Khadija ; Agrawal, Ajay ; Yadav, Punita ; Silwimba, Willies ; Lubeya, Mwansa Ketty ; Kruja, Aferdita ; Brahimaj, Besnik ; Tola, Armida ; Musau, Badibanga ; Kalyana, Herman ; Jason, Nzanzu Kikuhe ; Missumba, Willis ; Begum, Nazneen ; Paul, Shrodha ; Basta, Wafaa ; WOMAN Trial Collaborators</creatorcontrib><description>Summary Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov , number NCT00872469 ; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(17)30638-4</identifier><identifier>PMID: 28456509</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Acids ; Adolescent ; Adult ; Antifibrinolytic agents ; Antifibrinolytic Agents - administration & dosage ; Birth ; Bleeding ; Charities ; Childbirth & labor ; Clinical outcomes ; Clinical trials ; Consent ; Death ; Double-Blind Method ; Double-blind studies ; Drug Administration Schedule ; Drug therapy ; Enzymes ; Evidence-based medicine ; Fatalities ; Female ; Hemorrhage ; Humans ; Hygiene ; Hysterectomy ; Internal Medicine ; Intravenous administration ; Maternal Death ; Maternal mortality ; Mortality ; Motivation ; Outcome Assessment (Health Care) ; Patients ; Postpartum ; Postpartum Hemorrhage - mortality ; Postpartum Hemorrhage - prevention & control ; Postpartum Hemorrhage - surgery ; Postpartum period ; Pregnancy ; Randomization ; Risk ; Side effects ; Surgery ; Systematic review ; Thromboembolism ; Tranexamic Acid - administration & dosage ; Trauma ; Vagina ; Womens health</subject><ispartof>The Lancet (British edition), 2017-05, Vol.389 (10084), p.2105-2116</ispartof><rights>The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license</rights><rights>2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license</rights><rights>Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.</rights><rights>Copyright Elsevier Limited May 27, 2017</rights><rights>2017. The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license.</rights><rights>2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c630t-a7d8edbbb46bed2a6b862426a509cb7ab20f0d2bf79e6fe1631b9ee375fbad603</citedby><cites>FETCH-LOGICAL-c630t-a7d8edbbb46bed2a6b862426a509cb7ab20f0d2bf79e6fe1631b9ee375fbad603</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673617306384$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28456509$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fawole, Bukola</creatorcontrib><creatorcontrib>Qureshi, Zahida</creatorcontrib><creatorcontrib>Abdulkadir, Abdulfetah</creatorcontrib><creatorcontrib>Afsana, Kaosar</creatorcontrib><creatorcontrib>Lumbiganon, Pisake</creatorcontrib><creatorcontrib>Piaggio, Gilda</creatorcontrib><creatorcontrib>Elbourne, Diana</creatorcontrib><creatorcontrib>Gilliam, Catherine</creatorcontrib><creatorcontrib>Kostrov, Sergey</creatorcontrib><creatorcontrib>Godec, Tom</creatorcontrib><creatorcontrib>Regmi, Mohan</creatorcontrib><creatorcontrib>Odekunle, Olufemi</creatorcontrib><creatorcontrib>Offiah, Ifeoma</creatorcontrib><creatorcontrib>Akpan, Ubong</creatorcontrib><creatorcontrib>Omoronyia, Ezukwa</creatorcontrib><creatorcontrib>Aimakhu, Chris</creatorcontrib><creatorcontrib>Akinsanya, Olufemi</creatorcontrib><creatorcontrib>Adeyemi, Oluwaseun</creatorcontrib><creatorcontrib>Aboyeji, Abiodun</creatorcontrib><creatorcontrib>Adewale, Adebayo</creatorcontrib><creatorcontrib>Olaomo, Noah</creatorcontrib><creatorcontrib>Ogudu, John</creatorcontrib><creatorcontrib>Onafowokan, Olatunde</creatorcontrib><creatorcontrib>Isah, David</creatorcontrib><creatorcontrib>Salau, Olaide</creatorcontrib><creatorcontrib>Habeebu-Adeyemi, Fatimah</creatorcontrib><creatorcontrib>Idris, Hadiza</creatorcontrib><creatorcontrib>Opreh, Owigho</creatorcontrib><creatorcontrib>Udonwa, Sophia</creatorcontrib><creatorcontrib>Ifemeje, Arafat</creatorcontrib><creatorcontrib>Adamu, Yusuf Baffah</creatorcontrib><creatorcontrib>Adekola-Oni, Grace</creatorcontrib><creatorcontrib>Kua, Paul</creatorcontrib><creatorcontrib>Awoleke, Jacob</creatorcontrib><creatorcontrib>Sulayman, Hajaratu</creatorcontrib><creatorcontrib>Ameh, Nkeiruka</creatorcontrib><creatorcontrib>Adelodun, Affiss</creatorcontrib><creatorcontrib>Adeniji, Adetunji</creatorcontrib><creatorcontrib>Oyelade, Folasade</creatorcontrib><creatorcontrib>Henry, Palmer</creatorcontrib><creatorcontrib>Loto, Olabisi</creatorcontrib><creatorcontrib>Adeniyi, Augustine</creatorcontrib><creatorcontrib>Ikpen, Akpojaro</creatorcontrib><creatorcontrib>Nwosu, Ikemefuna</creatorcontrib><creatorcontrib>Abubakar, Sola</creatorcontrib><creatorcontrib>Jabeen, Kiran</creatorcontrib><creatorcontrib>Asmat, Raheela</creatorcontrib><creatorcontrib>Bukhari, Syeda Rabia</creatorcontrib><creatorcontrib>Gul, Fouzia</creatorcontrib><creatorcontrib>Sherin, Akhtar</creatorcontrib><creatorcontrib>Ain, Qurratul</creatorcontrib><creatorcontrib>Shaheen, Uzma</creatorcontrib><creatorcontrib>Rizvi, Shabana</creatorcontrib><creatorcontrib>Manzoor, Sofia</creatorcontrib><creatorcontrib>Tasnim, Nasira</creatorcontrib><creatorcontrib>Bashir, Lubna</creatorcontrib><creatorcontrib>Iqbal, Saima</creatorcontrib><creatorcontrib>Dojki, Samina</creatorcontrib><creatorcontrib>Aslam, Summera</creatorcontrib><creatorcontrib>Mustafa, Nilofar</creatorcontrib><creatorcontrib>Waqar, Fareesa</creatorcontrib><creatorcontrib>Nuulu, Nakirigya</creatorcontrib><creatorcontrib>Bwotya, Rose</creatorcontrib><creatorcontrib>Ngonzi, Joseph</creatorcontrib><creatorcontrib>Innocent, Nkonwa</creatorcontrib><creatorcontrib>Anitah, Kusasira</creatorcontrib><creatorcontrib>Meregurwa, Grace</creatorcontrib><creatorcontrib>Oyiengo, Vincent</creatorcontrib><creatorcontrib>Wangui, Rose</creatorcontrib><creatorcontrib>Nassir, Faiza</creatorcontrib><creatorcontrib>Osoti, Alfred</creatorcontrib><creatorcontrib>Ongwae, Veronicah</creatorcontrib><creatorcontrib>Wanjohi, Victor</creatorcontrib><creatorcontrib>Ashu, Alice</creatorcontrib><creatorcontrib>Simo, André</creatorcontrib><creatorcontrib>Tchana, Mesack</creatorcontrib><creatorcontrib>Umbeli, Taha</creatorcontrib><creatorcontrib>Abdelrahiem, Somia</creatorcontrib><creatorcontrib>Awadalla, Khidir</creatorcontrib><creatorcontrib>Abdullahi, Hala</creatorcontrib><creatorcontrib>Hinshaw, Kim</creatorcontrib><creatorcontrib>Ayuk, Paul</creatorcontrib><creatorcontrib>Wilkins, Joanne</creatorcontrib><creatorcontrib>Tower, Clare</creatorcontrib><creatorcontrib>Allibone, Alysha</creatorcontrib><creatorcontrib>Mayumba, Khadija</creatorcontrib><creatorcontrib>Agrawal, Ajay</creatorcontrib><creatorcontrib>Yadav, Punita</creatorcontrib><creatorcontrib>Silwimba, Willies</creatorcontrib><creatorcontrib>Lubeya, Mwansa Ketty</creatorcontrib><creatorcontrib>Kruja, Aferdita</creatorcontrib><creatorcontrib>Brahimaj, Besnik</creatorcontrib><creatorcontrib>Tola, Armida</creatorcontrib><creatorcontrib>Musau, Badibanga</creatorcontrib><creatorcontrib>Kalyana, Herman</creatorcontrib><creatorcontrib>Jason, Nzanzu Kikuhe</creatorcontrib><creatorcontrib>Missumba, Willis</creatorcontrib><creatorcontrib>Begum, Nazneen</creatorcontrib><creatorcontrib>Paul, Shrodha</creatorcontrib><creatorcontrib>Basta, Wafaa</creatorcontrib><creatorcontrib>WOMAN Trial Collaborators</creatorcontrib><title>Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov , number NCT00872469 ; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.</description><subject>Acids</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Antifibrinolytic agents</subject><subject>Antifibrinolytic Agents - administration & dosage</subject><subject>Birth</subject><subject>Bleeding</subject><subject>Charities</subject><subject>Childbirth & labor</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Consent</subject><subject>Death</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Enzymes</subject><subject>Evidence-based medicine</subject><subject>Fatalities</subject><subject>Female</subject><subject>Hemorrhage</subject><subject>Humans</subject><subject>Hygiene</subject><subject>Hysterectomy</subject><subject>Internal Medicine</subject><subject>Intravenous administration</subject><subject>Maternal Death</subject><subject>Maternal mortality</subject><subject>Mortality</subject><subject>Motivation</subject><subject>Outcome Assessment (Health Care)</subject><subject>Patients</subject><subject>Postpartum</subject><subject>Postpartum Hemorrhage - mortality</subject><subject>Postpartum Hemorrhage - prevention & control</subject><subject>Postpartum Hemorrhage - surgery</subject><subject>Postpartum period</subject><subject>Pregnancy</subject><subject>Randomization</subject><subject>Risk</subject><subject>Side effects</subject><subject>Surgery</subject><subject>Systematic review</subject><subject>Thromboembolism</subject><subject>Tranexamic Acid - administration & dosage</subject><subject>Trauma</subject><subject>Vagina</subject><subject>Womens 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of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial</title><author>Fawole, Bukola ; Qureshi, Zahida ; Abdulkadir, Abdulfetah ; Afsana, Kaosar ; Lumbiganon, Pisake ; Piaggio, Gilda ; Elbourne, Diana ; Gilliam, Catherine ; Kostrov, Sergey ; Godec, Tom ; Regmi, Mohan ; Odekunle, Olufemi ; Offiah, Ifeoma ; Akpan, Ubong ; Omoronyia, Ezukwa ; Aimakhu, Chris ; Akinsanya, Olufemi ; Adeyemi, Oluwaseun ; Aboyeji, Abiodun ; Adewale, Adebayo ; Olaomo, Noah ; Ogudu, John ; Onafowokan, Olatunde ; Isah, David ; Salau, Olaide ; Habeebu-Adeyemi, Fatimah ; Idris, Hadiza ; Opreh, Owigho ; Udonwa, Sophia ; Ifemeje, Arafat ; Adamu, Yusuf Baffah ; Adekola-Oni, Grace ; Kua, Paul ; Awoleke, Jacob ; Sulayman, Hajaratu ; Ameh, Nkeiruka ; Adelodun, Affiss ; Adeniji, Adetunji ; Oyelade, Folasade ; Henry, Palmer ; Loto, Olabisi ; Adeniyi, Augustine ; Ikpen, Akpojaro ; Nwosu, Ikemefuna ; Abubakar, Sola ; Jabeen, Kiran ; Asmat, Raheela ; Bukhari, Syeda Rabia ; Gul, Fouzia ; Sherin, Akhtar ; Ain, Qurratul ; Shaheen, Uzma ; Rizvi, Shabana ; Manzoor, Sofia ; Tasnim, Nasira ; Bashir, Lubna ; Iqbal, Saima ; Dojki, Samina ; Aslam, Summera ; Mustafa, Nilofar ; Waqar, Fareesa ; Nuulu, Nakirigya ; Bwotya, Rose ; Ngonzi, Joseph ; Innocent, Nkonwa ; Anitah, Kusasira ; Meregurwa, Grace ; Oyiengo, Vincent ; Wangui, Rose ; Nassir, Faiza ; Osoti, Alfred ; Ongwae, Veronicah ; Wanjohi, Victor ; Ashu, Alice ; Simo, André ; Tchana, Mesack ; Umbeli, Taha ; Abdelrahiem, Somia ; Awadalla, Khidir ; Abdullahi, Hala ; Hinshaw, Kim ; Ayuk, Paul ; Wilkins, Joanne ; Tower, Clare ; Allibone, Alysha ; Mayumba, Khadija ; Agrawal, Ajay ; Yadav, Punita ; Silwimba, Willies ; Lubeya, Mwansa Ketty ; Kruja, Aferdita ; Brahimaj, Besnik ; Tola, Armida ; Musau, Badibanga ; Kalyana, Herman ; Jason, Nzanzu Kikuhe ; Missumba, Willis ; Begum, Nazneen ; Paul, Shrodha ; Basta, Wafaa</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c630t-a7d8edbbb46bed2a6b862426a509cb7ab20f0d2bf79e6fe1631b9ee375fbad603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Acids</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Antifibrinolytic agents</topic><topic>Antifibrinolytic Agents - administration & dosage</topic><topic>Birth</topic><topic>Bleeding</topic><topic>Charities</topic><topic>Childbirth & labor</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Consent</topic><topic>Death</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Enzymes</topic><topic>Evidence-based 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Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fawole, Bukola</au><au>Qureshi, Zahida</au><au>Abdulkadir, Abdulfetah</au><au>Afsana, Kaosar</au><au>Lumbiganon, Pisake</au><au>Piaggio, Gilda</au><au>Elbourne, Diana</au><au>Gilliam, Catherine</au><au>Kostrov, Sergey</au><au>Godec, Tom</au><au>Regmi, Mohan</au><au>Odekunle, Olufemi</au><au>Offiah, Ifeoma</au><au>Akpan, Ubong</au><au>Omoronyia, Ezukwa</au><au>Aimakhu, Chris</au><au>Akinsanya, Olufemi</au><au>Adeyemi, Oluwaseun</au><au>Aboyeji, Abiodun</au><au>Adewale, Adebayo</au><au>Olaomo, Noah</au><au>Ogudu, John</au><au>Onafowokan, Olatunde</au><au>Isah, David</au><au>Salau, Olaide</au><au>Habeebu-Adeyemi, Fatimah</au><au>Idris, Hadiza</au><au>Opreh, Owigho</au><au>Udonwa, Sophia</au><au>Ifemeje, Arafat</au><au>Adamu, Yusuf Baffah</au><au>Adekola-Oni, Grace</au><au>Kua, Paul</au><au>Awoleke, Jacob</au><au>Sulayman, Hajaratu</au><au>Ameh, Nkeiruka</au><au>Adelodun, Affiss</au><au>Adeniji, Adetunji</au><au>Oyelade, Folasade</au><au>Henry, Palmer</au><au>Loto, Olabisi</au><au>Adeniyi, Augustine</au><au>Ikpen, Akpojaro</au><au>Nwosu, Ikemefuna</au><au>Abubakar, Sola</au><au>Jabeen, Kiran</au><au>Asmat, Raheela</au><au>Bukhari, Syeda Rabia</au><au>Gul, Fouzia</au><au>Sherin, Akhtar</au><au>Ain, Qurratul</au><au>Shaheen, Uzma</au><au>Rizvi, Shabana</au><au>Manzoor, Sofia</au><au>Tasnim, Nasira</au><au>Bashir, Lubna</au><au>Iqbal, Saima</au><au>Dojki, Samina</au><au>Aslam, Summera</au><au>Mustafa, Nilofar</au><au>Waqar, Fareesa</au><au>Nuulu, Nakirigya</au><au>Bwotya, Rose</au><au>Ngonzi, Joseph</au><au>Innocent, Nkonwa</au><au>Anitah, Kusasira</au><au>Meregurwa, Grace</au><au>Oyiengo, Vincent</au><au>Wangui, Rose</au><au>Nassir, Faiza</au><au>Osoti, Alfred</au><au>Ongwae, Veronicah</au><au>Wanjohi, Victor</au><au>Ashu, Alice</au><au>Simo, André</au><au>Tchana, Mesack</au><au>Umbeli, Taha</au><au>Abdelrahiem, Somia</au><au>Awadalla, Khidir</au><au>Abdullahi, Hala</au><au>Hinshaw, Kim</au><au>Ayuk, Paul</au><au>Wilkins, Joanne</au><au>Tower, Clare</au><au>Allibone, Alysha</au><au>Mayumba, Khadija</au><au>Agrawal, Ajay</au><au>Yadav, Punita</au><au>Silwimba, Willies</au><au>Lubeya, Mwansa Ketty</au><au>Kruja, Aferdita</au><au>Brahimaj, Besnik</au><au>Tola, Armida</au><au>Musau, Badibanga</au><au>Kalyana, Herman</au><au>Jason, Nzanzu Kikuhe</au><au>Missumba, Willis</au><au>Begum, Nazneen</au><au>Paul, Shrodha</au><au>Basta, Wafaa</au><aucorp>WOMAN Trial Collaborators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2017-05-27</date><risdate>2017</risdate><volume>389</volume><issue>10084</issue><spage>2105</spage><epage>2116</epage><pages>2105-2116</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><abstract>Summary Background Post-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage. Methods In this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov , number NCT00872469 ; and PACTR201007000192283. Findings Between March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus placebo group. Interpretation Tranexamic acid reduces death due to bleeding in women with post-partum haemorrhage with no adverse effects. When used as a treatment for postpartum haemorrhage, tranexamic acid should be given as soon as possible after bleeding onset. Funding London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>28456509</pmid><doi>10.1016/S0140-6736(17)30638-4</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0140-6736 |
ispartof | The Lancet (British edition), 2017-05, Vol.389 (10084), p.2105-2116 |
issn | 0140-6736 1474-547X |
language | eng |
recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5446563 |
source | MEDLINE; Elsevier ScienceDirect Journals Complete |
subjects | Acids Adolescent Adult Antifibrinolytic agents Antifibrinolytic Agents - administration & dosage Birth Bleeding Charities Childbirth & labor Clinical outcomes Clinical trials Consent Death Double-Blind Method Double-blind studies Drug Administration Schedule Drug therapy Enzymes Evidence-based medicine Fatalities Female Hemorrhage Humans Hygiene Hysterectomy Internal Medicine Intravenous administration Maternal Death Maternal mortality Mortality Motivation Outcome Assessment (Health Care) Patients Postpartum Postpartum Hemorrhage - mortality Postpartum Hemorrhage - prevention & control Postpartum Hemorrhage - surgery Postpartum period Pregnancy Randomization Risk Side effects Surgery Systematic review Thromboembolism Tranexamic Acid - administration & dosage Trauma Vagina Womens health |
title | Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial |
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