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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Veröffentlicht in:The Lancet (British edition) 2017-05, Vol.389 (10084), p.2105-2116
Hauptverfasser: 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
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container_issue 10084
container_start_page 2105
container_title The Lancet (British edition)
container_volume 389
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
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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 &amp; Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill &amp; 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 &amp; dosage ; Birth ; Bleeding ; Charities ; Childbirth &amp; 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 &amp; control ; Postpartum Hemorrhage - surgery ; Postpartum period ; Pregnancy ; Randomization ; Risk ; Side effects ; Surgery ; Systematic review ; Thromboembolism ; Tranexamic Acid - administration &amp; 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 &amp; Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill &amp; Melinda Gates Foundation.</description><subject>Acids</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Antifibrinolytic agents</subject><subject>Antifibrinolytic Agents - administration &amp; dosage</subject><subject>Birth</subject><subject>Bleeding</subject><subject>Charities</subject><subject>Childbirth &amp; 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 &amp; 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 &amp; 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 &amp; dosage</topic><topic>Birth</topic><topic>Bleeding</topic><topic>Charities</topic><topic>Childbirth &amp; 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 medicine</topic><topic>Fatalities</topic><topic>Female</topic><topic>Hemorrhage</topic><topic>Humans</topic><topic>Hygiene</topic><topic>Hysterectomy</topic><topic>Internal Medicine</topic><topic>Intravenous administration</topic><topic>Maternal Death</topic><topic>Maternal mortality</topic><topic>Mortality</topic><topic>Motivation</topic><topic>Outcome Assessment (Health Care)</topic><topic>Patients</topic><topic>Postpartum</topic><topic>Postpartum Hemorrhage - mortality</topic><topic>Postpartum Hemorrhage - prevention &amp; control</topic><topic>Postpartum Hemorrhage - surgery</topic><topic>Postpartum period</topic><topic>Pregnancy</topic><topic>Randomization</topic><topic>Risk</topic><topic>Side effects</topic><topic>Surgery</topic><topic>Systematic review</topic><topic>Thromboembolism</topic><topic>Tranexamic Acid - administration &amp; dosage</topic><topic>Trauma</topic><topic>Vagina</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><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, 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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 &amp; Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill &amp; 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>
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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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