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Effect of earlytranexamic acidadministration onmortality,hysterectomy, andother morbidities inwomen withpost-partumhaemorrhage (WOMAN) Haleema Shakur‐StillIan RobertsBukola Fawole2017 год

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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Аннотация: 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.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.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.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.London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.
Год издания: 2017
Авторы: Haleema Shakur‐Still, Ian Roberts, Bukola Fawole, Rizwana Chaudhri, Mohamed A. El‐Sheikh, Adesina Akintan, Zahida Qureshi, Hussein Kidanto, Bellington Vwalika, Abdulfetah Abdulkadir, Saturday Etuk, Shehla Noor, Etienne Asonganyi, Žarko Alfirević, Danielle Beaumont, Carine Ronsmans, Sabaratnam Arulkumaran, Adrian Grant, Kaosar Afsana, Metin Gülmezoglu, Beverley J. Hunt, Oladapo Olayemi, Ian Roberts, Iain Chalmers, Pisake Lumbiganon, Gilda Piaggio, Tony Brady, Haleema Shakur‐Still, Ian Roberts, Žarko Alfirević, Diana Elbourne, Metin Gülmezoglu, Carine Ronsmans, Eni Balogun, Tracey Pepple, Danielle Prowse, Nigel Quashi, Lin Barneston, Collette Barrow, Danielle Beaumont, Lisa Cook, Lauren Frimley, Daniel Gilbert, Catherine Gilliam, Rob Jackson, Taemi Kawahara, Hakim Miah, Sergey Kostrov, Maria Ramos, Ian Roberts, Haleema Shakur‐Still, Phil Edwards, Thomas Godec, Sumaya Huque, Bukola Fawole, Olujide Okunade, Olusade Adetayo, Rizwana Chaudhri, Aasia Kayani, Kiran Javaid, Bukola Fawole, Rizwana Chaudhri, Chrstine Biryabarema, Zahida Qureshi, Robert Tchounzou, Mohamed A. El‐Sheikh, Hussein Kidanto, Mohan Chandra Regmi, Bellington Vwalika, Kastriot Dallaku, Mateus Sahani, Sohail Akhter, Abdulfetah Abdulkadir, Nicolas Méda, Anthony Kwame Dah, Adesina Akintan, Olufemi Odekunle, Oluwabusola Monehin, Austin Ojo, Grace Akinbinu, Ifeoma Offiah, Saturday Etuk, Ubong Akpan, Uduak Udofia, Useneno Okon, Ezukwa Omoronyia, Okpe James, Oladapo Olayemi, Folasade Adenike Bello, B F Adeyemi, Chris Aimakhu, Olufemi Akinsanya, Bamidele Adeleye, Oluwaseun Adeyemi, K. Shittu Oluwatosin, AP Aboyeji, Abiodun S. Adeniran, Adebayo Adewale, Noah Olaomo, Lawrence Omo‐Aghoja, Emmanuel Okpako, Lucky Oyeye, Francis E. Alu, John Ogudu, Ezekiel Ladan, Ibrahim Habib, Babasola O. Okusanya, Olatunde Onafowokan, David Isah, Abalaka A. Aye, F Okogbo, Egbaname Obozegie Samuel Aigere, Mark Ogbiti, Temitope G. Onile, Olaide Salau, Yinka Amode, Kamil Shoretire, Adebola Owodunni, Kehinde Ologunde, Akintunde Ayinde, Moses O. Alao, Olalekan Awonuga, Babatunde S. Awolaja, Omololu Adegbola, Fatimah Murtazha Habeebu-Adeyemi, Adeyemi Okunowo, Hadiza Idris, Ola Okike, Nneka Madueke, Josiah Mutihir, Nankat Joseph, Babatunde Adebudo, Adeniyi Olanipekun Fasanu, Olugbenga Akintunde, Olufemi E Abidoye, Owigho Opreh, Sophia Udonwa, Gladys Dibia, Simeon Bazuaye, Arafat Ifemeje, Aniefiok J. Umoiyoho, Emmanuel Columba Inyang-Etoh, Sununu Yusuf, Kayode Olayinka, Babalola Adeyemi, Olusegun Kayode Ajenifuja, Umar Ibrahim, Yusuf Baffah Adamu, OI Akinola, Grace Adekola-Oni, Paul L Kua, Roseline Beauty Iheagwam, A Idrisa, Ado Danazumi Geidam, Andrea Jogo, Joseph Chiahemba Agulebe, Joseph Ifeanyichukwu Ikechebelu, Onyebuchi Izuchukwu udegbunam, Jacob Olumuyiwa Awoleke, Oluseyi Adelekan, Hajaratu Umar Sulayman, Nkeiruka Ameh, Nurudeen Onaolapo, Affiss Adelodun, William Golit, Dachollom Audu, AO Adeniji, Folasade Oyindamola Oyelade, Lamaran Makama Dattijo, P. Henry, Babalola Adeyemi, Olabisi Loto, OUJ Umeora, Abraham Bong Onwe, Emily Nzeribe, B. C. Okorochukwu, Adebayo Augustine Adeniyi, Emmanuel Hero Gbejegbe, Akpojaro Ikpen, Ikemefuna Nwosu, Abdulrasaq Sambo, Olubunmi Ladipo, Sola Abubakar, Ola Okike, Enyinnaya Chikwendu Nduka, Eziamaka Pauline Ezenkwele, Daniel N. Onwusulu, Theresa Azonima Irinyenikan, Swati Singh, Amaitari Bariweni, Hadiza Galadanci, Peter Achara, Osagie Osayande, Mohammed Gana, Rizwana Chaudhri, Kiran Jabeen, Ayesha Mobeen, Sadaf Mufti, Maliha Zafar, Shehla Noor, Ahmad Basharat, Maimoona Munawar, Jeharat Gul, Naseema Usman, Fehmida Shaheen, Mariam Tariq, Nadia Sadiq, Rabia Batool, Habiba Sharaf Ali, Manahil Jaffer, Asma Baloch, Noonari Mukhtiar, Tasneem Ashraf, Raheela Asmat, Salma Khudaidad, Ghazala Taj, Roshan Ara Qazi, Saira Dars, Faryal Sardar, Sanobar Ashfaq, Saeeda Majeed, Sadaqat Jabeen, Rukhsana Karim, Farzana Burki, Syeda Rabia Bukhari, Fouzia Gul, Musarrat Jabeen, Akhtar Sherin, Qurratul Ain, Shahid Irshad Rao, Uzma Shaheen, Samina Manzoor, Shabween Masood, Shabana Rizvi, Anita Ali, Abida Sajid, Aisha Iftikhar, Shazia Batool, Lubna Riaz Dar, Shahenzad Sohail, Shazia Rasul, Shamsa Humayun, Rashida Sultana, Sofia Manzoor, Syeda Batool Mazhar, Afshan Batool, Asia Nazir, Nasira Tasnim, Hajira Masood, Razia Bahadur Khero, Neelam Surhio, Samana Aleem, Naila Israr, Saba Javed, Lubna Bashir, Samina Iqbal, Faiza Aleem, Rubina Sohail, Saima Iqbal, Samina Saleem Dojki, Alia Bano, Naseem Saba, Maimoona Hafeez, Nishat Akram, Naila Israr, Riffat Shaheen, Haleema A Hashmi, Sharmeen Arshad, Rubina Hussain, Sadia Jabeen Khan, Nighat Shaheen, Safia Khalil, Pushpa Sirichand Sachdev, Gulfareen Arain, Amtullah Zarreen, Sara Saeed, Shamayela Hanif, Nabia Tariq, Mahwish Jamil, Shama Chaudhry, Hina Rajani, Tayyiba Wasim, Summera Aslam, Nilofar Mustafa, Huma Quddusi, Sajila Karim, Shazia Sultana, Misbah Harim, Mohd Chohan, Nabila Salman, Fareesa Waqar, Shamsunnisa Sadia, Lubna Kahloon, Shehla Manzoor, Samar Amin, Umbreen Akram, Ambreen Ikram, Samina Kausar, Tahira Batool, Brigadier Naila, Tahir Kyani, Christine Biryabarema, Ruth Bulime, Regina Akello, Bernadette Nakawooya Lwasa, Joselyn Ayikoru, Christine Namulwasira, Patrick Komagum, I Schneider Rebecca, Nayiga Annet, Nakirigya Nuulu, Elizabeth Nionzima, Rose Bwotya, Margret Nankya, Sarah Babirye, Joseph Ngonzi, Sanchez Cesar, Nkonwa Innocent, Kusasira Anitah, Ayiko Jackson, Elizabeth Ndagire, Christine Nanyongo, Dominic Drametu, Grace Meregurwa, Francis Banya, Rita Atim, Emmanuel Byaruhanga, Lema Felix, Hussein Iman, Vincent Oyiengo, Peninah Waigi, Rose Wangui, Faiza Nassir, Musimbi Soita, Rophina Msengeti, Zeinab Zubier, Hillary Mabeya, Antony Wanjala, Henry Mwangi, Brian Liyayi, Evelyn Muthoka, Alfred Osoti, Amos Otara, Veronicah Ongwae, Zahida Qureshi, Victor Wanjohi, Bonface Musila, Kubasu Wekesa, Alex Nyakundi Bosire, Etienne Asonganyi, Alice Ntem, Angeline Njoache, Alice Ashu, André Simo, Robert Tchounzou, Dorothy Keka, Bruno Kenfack, Amadou Ndouoya, Martin Saadio, Mesack Tchana, Odel Gwan, Pauline Assomo, Venantius Mutsu, Nji Eric, Pascal Foumane, Philemon Nsem, Jeanne Hortence Fouedjio, Ymele Fouelifack, Pierre Marie Tebeu, Georges Nko'ayissi, Eta Ngole Mbong, Wisal Nabag, Riham Desougi, Hadia Mustafa, Huida Eltaib, T Umbeli, Khalid Elfadl, Murwan Ibrahim, Abdalla Mohammed, Awadia Ali, Somia K. Abdelrahiem, Mohammed H. Musa, Khidir E. Awadalla, Samirra Ahmed, M. Bushra, Omer Babiker, Hala Abdullahi, Mohamed E. Ahmed, Elhassan Safa, Huida Almardi, Duria A. Rayis, Saeed Abdelrahman Abdelgabar, Žarko Alfirević, Gillian Houghton, Andrew Sharpe, Jim Thornton, Nick Grace, Carys Smith, Kim Hinshaw, Dawn Edmundson, Paul Ayuk, A. Bates, George Bugg, Joanne Wilkins, Clare Tower, Alysha Allibone, Eugene Oteng-Ntim, Hussein Kidanto, Ahmad Kazumari, A. Danford, Matilda Ngarina, Muzdalifat Abeid, Khadija Mayumba, Magreth Zacharia, George Mtove, Leonard Madame, Anthony Massinde, Berno Mwambe, Rwakyendela Onesmo, Sebastian Kitengile Ganyaka, Mohan Chandra Regmi, Shyam Gupta, Rabindra Bhatt, Ajay Agrawal, Pramila Pradhan, Nikita Dhakal, Punita Yadav, Gyanendra Man Singh Karki, Bhola Ram Shrestha, Bellington Vwalika, Mwansa Ketty Lubeya, Jane Mumba, Willies Silwimba, Isaiah Hansingo, Noojiri Bopili, Ziche Makukula, Alexander Kawimbe, Mwansa Ketty Lubeya, Willard Mtambo, Mathew Ng'ambi, Kastriot Dallaku, Saimir Cenameri, Ilir Tasha, Aferdita Kruja, Besnik Brahimaj, Armida Tola, Leon Kaza, Mateus Sahani, Desire Tshombe, Elizabeth Buligho, Roger Paluku-Hamuli, Charles Kacha, Kato Faida, Badibanga Musau, Herman Kalyana, Phanny Simisi, Serge Mulyumba, Nzanzu Kikuhe Jason, Jean Robert Lubamba, Willis Missumba, Ferdousi Islam, Nazneen Begum, Sohail Akhter, Ferdousi Chowdhury, Rokeya Begum, Farjana Basher, Nazlima Nargis, Abu Kholdun, Shahela Jesmin, Shrodha Paul, Hailemariam Segni, Getachew Ayana, William Haleke, Abdulfetah Abdulkadir, Hassen Hussien, Fikre Geremew, M Bambara, Adolphe Somé, Amadou Ly, Roamba Pabakba, Horace Fletcher, Leslie A. Samuels, Henry S. Opare‐Addo, Roderick Larsen‐Reindorf, Kwadwo Nyarko-Jectey, Glen Mola, Malts Wai, Magdy El Rahman, Wafaa Basta, Hussein Khamis, María Fernanda Escobar, Liliana Vallecilla, Gabriel Essetchi Faye
Издательство: Elsevier BV
Источник: The Lancet
Ключевые слова: Maternal and fetal healthcare, Pregnancy and preeclampsia studies, Congenital Diaphragmatic Hernia Studies
Другие ссылки: The Lancet (PDF)
The Lancet (HTML)
Europe PMC (PubMed Central) (PDF)
Europe PMC (PubMed Central) (HTML)
LSHTM Research Online (London School of Hygiene & Tropical Medicine) (HTML)
PubMed Central (HTML)
LSHTM Research Online (London School of Hygiene & Tropical Medicine) (HTML)
St George's Online Research Archive (St George's University of London) (HTML)
PubMed (HTML)