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1. Giant 'Hydra Headed' Uterine Fibroid in a Nullipara: A Case Report

Author

Emeka Igbodike, Ijeoma Iwuala, Chijioke Mbonu, Ugwu Okechukwu, Anas Funtua, George Eleje, Andrea Akinjo, Akaninyene Ubom, Joseph Ikechebelu, Charles Anunobi, and Onwudiegwu Uche

Subjects
Medicine (General), R5-920
Abstract

Background: Uterine fibroids, or Leiomyoma is a type of Smooth Muscle Tumors of the uterus (SMTs) and are common in the black race. Giant uterine fibroids, on the other hand, are uncommon and may occur during patient dissimulation. Dissimulation may occur because of a dread of surgery and hospitals visits, fear of surgical death, chronic intake of herbal concussion, and a religio-traditional strong belief system on instant healing following prayers, among others. Myths like belief of defecating the uterine fibroids, some herbs that can melt them away, and the belief that such illness may follow ancestral curses can fuel dissimulation. The surgical approach can be a source of challenge, careful case selection considering the size and number of tumors can be helpful. Case report: We present a 35-year-old nulligravida who presented to the clinic with a 14-year history of progressive abdominal swelling. Examination revealed a firm mass with a symphysio-fundal height of 55 cm. She subsequently had an open abdominal myomectomy with all the myoma nodules weighing 12.9 kg in total! Histology confirmed uterine fibroid. Conclusion: It is possible to offer open myomectomy in patients with giant uterine fibroid following careful patient selection with a consent for possible hysterectomy. Dissimulation can be minimized with repetitive counseling of patients. The choice of surgery depends on the size and number of uterine fibroids, but surgical approach does not necessarily influence fecundity.

Published
2024
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2. Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals

Author

Jamilu Tukur, Tina Lavin, Abiodun Adanikin, Muhammed Abdussalam, Kuti Bankole, Mabel Ikpim Ekott, Akaba Godwin, Halima A Ibrahim, Okonkwo Ikechukwu, Saidu Abubakar Kadas, Linda Nwokeji-Onwe, Emily Nzeribe, Taofik Oluwaseun Ogunkunle, Lawal Oyeneyin, Karima A. Tunau, Musa Bello, Is'haq Aminu, Bosede Ezekwe, Peter Aboyeji, Olubukola A. Adesina, Calvin Chama, Saturday Etuk, Hadiza Galadanci, Joseph Ikechebelu, and Olufemi T. Oladapo

Subjects
Maternal mortality, Neonatal mortality, Maternal morbidity, Quality of care, Medicine (General), R5-920
Abstract

Summary: Background: The WHO in collaboration with the Nigeria Federal Ministry of Health, established a nationwide electronic data platform across referral-level hospitals. We report the burden of maternal, foetal and neonatal complications and quality and outcomes of care during the first year. Methods: Data were analysed from 76,563 women who were admitted for delivery or on account of complications within 42 days of delivery or termination of pregnancy from September 2019 to August 2020 across the 54 hospitals included in the Maternal and Perinatal Database for Quality, Equity and Dignity programme. Findings: Participating hospitals reported 69,055 live births, 4,498 stillbirths and 1,090 early neonatal deaths. 44,614 women (58·3%) had at least one pregnancy complication, out of which 6,618 women (8·6%) met our criteria for potentially life-threatening complications, and 940 women (1·2%) died. Leading causes of maternal death were eclampsia (n = 187,20·6%), postpartum haemorrhage (PPH) (n = 103,11·4%), and sepsis (n = 99,10·8%). Antepartum hypoxia (n = 1455,31·1%) and acute intrapartum events (n = 913,19·6%) were the leading causes of perinatal death. Predictors of maternal and perinatal death were similar: low maternal education, lack of antenatal care, referral from other facility, previous caesarean section, latent-phase labour admission, operative vaginal birth, non-use of a labour monitoring tool, no labour companion, and non-use of uterotonic for PPH prevention. Interpretation: This nationwide programme for routine data aggregation shows that maternal and perinatal mortality reduction strategies in Nigeria require a multisectoral approach. Several lives could be saved in the short term by addressing key predictors of death, including gaps in the coverage of internationally recommended interventions such as companionship in labour and use of labour monitoring tool. Funding: This work was funded by MSD for Mothers; and UNDP/UNFPA/ UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a co-sponsored programme executed by the World Health Organization (WHO).

Published
2022
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3. A Five-Year Review of Feto-Maternal Outcome of Antepartum Haemorrhage in a Tertiary Center in Nigeria

Author

Charlotte Oguejiofor, Chidimma Okafor, George Eleje, Joseph Ikechebelu, Chigozie Okafor, Joseph Ugboaja, Chukwudi Ogabido, Tobechi Njoku, Osita Umeononihu, Boniface Okpala, Malarchy Nwankwo, Chijioke Ezeigwe, Chukwunonso Enechukwu, and Ahizechukwu Eke

Subjects
General Medicine
Abstract

Background: Pregnancies complicated with antepartum-haemorrhage is high risk pregnancies associated with adverse maternal, fetal-and-perinatal-outcomes. It contributes significantly to fetal and maternal mortality especially in the developing countries. Proper antenatal care and prompt intervention is necessary to forestall adverse and improve outcome. Objective: To determine the prevalence, sociodemographic characteristics, risk factors, fetomaternal outcome of pregnancies with antepartum haemorrhage. Methods: The case files of the patients were retrieved from the medical records department. The total number of deliveries within the study period was obtained from the labour ward records. The feto-maternal-outcome-measures were; prevalence of caesarean-section, postpartum-haemorrhage, hysterectomy, need for blood-transfusion, maternal-death, prematurity, need for admission in intensive-care-unit and still births. The data was analysed using SPSS version 21. Chi-square was used to test for significance. Results: Within the 5-year period under review, out of a total of 6974 deliveries, 234 had antepartum-haemorrhage (3.4% prevalence rate). Abruptio-placentae was the commonest cause and accounted for 69.5% of the cases (prevalence of 2.1%) while placenta praevia accounted for 28.2% of the cases (prevalence rate of 0.9%). The mean age of the women was 31.8±5.3 years. The mean parity was 3.4±1.7 and majority (63.8%) of the women were unbooked. The commonest identifiable risk factors were multiparity and advanced maternal age. One-hundred-and sixty-six (77.9%) women were delivered through the abdominal route. Postpartum-haemorrhage occurred in 22.1% (47) of the cases while prematurity was the commonest fetal complications. Maternal mortality was 0.47% (1) while still birth was 44.1% (94). Conclusion: There is high prevalence of antepartum-haemorrhage in our environment. Abruptio-placentae was the commonest cause and associated with significant adverse fetomaternal-outcome when compared with placenta-praevia. Thus, good and quality antenatal care as well as high index of suspicion, prompt diagnosis and treatment remain the key to forestall these complications and improve fetomaternal-outcome.

Published
2023
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4. Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals

Author

Jamilu Tukur, Tina Lavin, Abiodun Adanikin, Muhammed Abdussalam, Kuti Bankole, Mabel Ikpim Ekott, Akaba Godwin, Halima A Ibrahim, Okonkwo Ikechukwu, Saidu Abubakar Kadas, Linda Nwokeji-Onwe, Emily Nzeribe, Taofik Oluwaseun Ogunkunle, Lawal Oyeneyin, Karima A. Tunau, Musa Bello, Is'haq Aminu, Bosede Ezekwe, Peter Aboyeji, Olubukola A. Adesina, Calvin Chama, Saturday Etuk, Hadiza Galadanci, Joseph Ikechebelu, Olufemi T. Oladapo, Abiodun S Adeniran, Aishatu A Gobir, Amaka Ocheke, Fatimah Baba Joy, Ibrahim Rais, Amsa B Mairami, Mohammed S. Ozegya, Samuel Pam, Sarah Ango, Musa Abdulkarim Omoyine, Medupin Patricia, Silas Ochejele, Egwu Agada, Duum Nwachukwu, Grace Ahmed, Aisha Abdurrahman, Lawal M Ibrahim, Aisha Nana Adamu, Aliyu Na'uzo, Adewale Ashimi, Umma Idris, Owodunni A Adebola, Festus D Akeredolu, Asma'u Adamu, Aliyu Labaran, Adekunle Oguntayo, Abdulkadir Isa, Stephen Bature, Andeyantso E Ayuba, Hauwa Abdullahi, Zubaida L Farouk, Sulaiman Muhammad Daneji, Umar Isa, Samuel Adelaiye, Ismail M Kalle, Saidu A Kadas, Muhammad F Bashir, Joel Moruppa, Wasinda S Bulus, Usman R. Yahaya, Jalo Iliya, Abdulkarim Mairiga, Adamu Atterwahmie, Abdulhakeem Hamza, Ishaya Wanonyi, Uniga A John, Wole Ayegbusi, Adefemi Ayodeji, Zainab Imam, Opeyemi Akinajo, Iretiola Fajolu, Olufemi Akinsanya, Efeturi Agelebe, Timothy Oluwasola, Olukemi O Tongo, Olusoji Jagun, Kuponiyi Opeyemi, Olumide Kuku, Abimbola Akindolire, David O Awonuga, Iyabode Olabisi F. Dedeke, Francis Akinkunmi, Babatunde Olofinbiyi, Ogundare E Olatunde, Olufemi Aworinde, Olusoji Adeyanju, Campbell Ibijoke, Adedapo B Ande, Aniekan Abbasiatai, Eno Etim Nyong, Sunny Ochigbo, Lawrence Omo‐Aghoja, Patrick Ekpebe, Anthonia Njoku, Andrew Eigbedion, Ngozi Orazulike, Chioma Okechukwu, Solomon Igbaruma, Idemudia Ebe, Osahon Ede-Edokpolor, Amarabia Ibeawuchi, Isa Ayuba Ibrahim, Oyedeji O Adeyemi, Chukwuemeka C Mgbafulu, Onubogu C Ukamaka, Ugwu Anayochukwu, Uchenna Ekwochi, Obinna-Njoku Chioma, George Eleje, Eziamaka P Ezenkwele, Ijeoma Obumneme-Anyim, Nnabuike Ojiegbe, Nathan U Nwokeforo, Ifeanyichukwu Ezebialu, and Obiora Ejiofor

Subjects
General Medicine
Abstract

The WHO in collaboration with the Nigeria Federal Ministry of Health, established a nationwide electronic data platform across referral-level hospitals. We report the burden of maternal, foetal and neonatal complications and quality and outcomes of care during the first year.Data were analysed from 76,563 women who were admitted for delivery or on account of complications within 42 days of delivery or termination of pregnancy from September 2019 to August 2020 across the 54 hospitals included in the Maternal and Perinatal Database for Quality, Equity and Dignity programme.Participating hospitals reported 69,055 live births, 4,498 stillbirths and 1,090 early neonatal deaths. 44,614 women (58·3%) had at least one pregnancy complication, out of which 6,618 women (8·6%) met our criteria for potentially life-threatening complications, and 940 women (1·2%) died. Leading causes of maternal death were eclampsia (This nationwide programme for routine data aggregation shows that maternal and perinatal mortality reduction strategies in Nigeria require a multisectoral approach. Several lives could be saved in the short term by addressing key predictors of death, including gaps in the coverage of internationally recommended interventions such as companionship in labour and use of labour monitoring tool.This work was funded by MSD for Mothers; and UNDP/UNFPA/ UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a co-sponsored programme executed by the World Health Organization (WHO).

Published
2021

5. 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

Author

Haleema Shakur, Ian Roberts, Bukola Fawole, Rizwana Chaudhri, Mohamed El-Sheikh, Adesina Akintan, Zahida Qureshi, Hussein Kidanto, Bellington Vwalika, Abdulfetah Abdulkadir, Saturday Etuk, Shehla Noor, Etienne Asonganyi, Zarko Alfirevic, Danielle Beaumont, Carine Ronsmans, Sabaratnam Arulkumaran, Adrian Grant, Kaosar Afsana, Metin Gülmezoglu, Beverley Hunt, Oladapo Olayemi, Iain Chalmers, Pisake Lumbiganon, Gilda Piaggio, Tony Brady, Diana Elbourne, Eni Balogun, Tracey Pepple, Danielle Prowse, Nigel Quashi, Lin Barneston, Collette Barrow, Lisa Cook, Lauren Frimley, Daniel Gilbert, Catherine Gilliam, Rob Jackson, Taemi Kawahara, Hakim Miah, Sergey Kostrov, Maria Ramos, Phil Edwards, Tom Godec, Sumaya Huque, Olujide Okunade, Olusade Adetayo, Aasia Kayani, Kiran Javaid, Chrstine Biryabarema, Robert Tchounzou, Mohan Regmi, Kastriot Dallaku, Mateus Sahani, Sayeba Akhter, Nicolas Meda, Anthony Kwame Dah, Olufemi Odekunle, Oluwabusola Monehin, Austin Ojo, Grace Akinbinu, Ifeoma Offiah, Ubong Akpan, Uduak Udofia, Useneno Okon, Ezukwa Omoronyia, Okpe James, Nike Bello, Blessed Adeyemi, Chris Aimakhu, Olufemi Akinsanya, Bamidele Adeleye, Oluwaseun Adeyemi, Kayode Oluwatosin, Abiodun Aboyeji, Abiodun Adeniran, Adebayo Adewale, Noah Olaomo, Lawrence Omo-Aghoja, Emmanuel Okpako, Lucky Oyeye, Francis Alu, John Ogudu, Ezekiel Ladan, Ibrahim Habib, Babasola Okusanya, Olatunde Onafowokan, David Isah, Abalaka Aye, Felix Okogbo, Egbaname Aigere, Mark Ogbiti, Temitope Onile, Olaide Salau, Yinka Amode, Kamil Shoretire, Adebola Owodunni, Kehinde Ologunde, Akintunde Ayinde, Moses Alao, Olalekan Awonuga, Babatunde Awolaja, Omololu Adegbola, Fatimah Habeebu-Adeyemi, Adeyemi Okunowo, Hadiza Idris, Ola Okike, Nneka Madueke, Josiah Mutihir, Nankat Joseph, Babatunde Adebudo, Adeniyi Fasanu, Olugbenga Akintunde, Olufemi Abidoye, Owigho Opreh, Sophia Udonwa, Gladys Dibia, Simeon Bazuaye, Arafat Ifemeje, Aniefiok Umoiyoho, Emmanuel Inyang-Etoh, Sununu Yusuf, Kayode Olayinka, Babalola Adeyemi, Olusegun Ajenifuja, Umar Ibrahim, Yusuf Baffah Adamu, Oluwarotimi Akinola, Grace Adekola-Oni, Paul Kua, Roseline Iheagwam, Audu Idrisa, Ado Geidam, Andrea Jogo, Joseph Agulebe, Joseph Ikechebelu, Onyebuchi Udegbunam, Jacob Awoleke, Oluseyi Adelekan, Hajaratu Sulayman, Nkeiruka Ameh, Nurudeen Onaolapo, Affiss Adelodun, William Golit, Dachollom Audu, Adetunji Adeniji, Folasade Oyelade, Lamaran Dattijo, Palmer Henry, Olabisi Loto, Odidika Umeora, Abraham Onwe, Emily Nzeribe, Bartthy Okorochukwu, Augustine Adeniyi, Emmanuel Gbejegbe, Akpojaro Ikpen, Ikemefuna Nwosu, Abdulrasaq Sambo, Olubunmi Ladipo, Sola Abubakar, Ola Nene Okike, Enyinnaya Chikwendu Nduka, Eziamaka Pauline Ezenkwele, Daniel Onwusulu, Theresa Azonima Irinyenikan, Swati Singh, Amaitari Bariweni, Hadiza Galadanci, Peter Achara, Osagie Osayande, Mohammed Gana, Kiran Jabeen, Ayesha Mobeen, Sadaf Mufti, Maliha Zafar, Basharat Ahmad, 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 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 Rao, Uzma Shaheen, Samina Manzoor, Shabween Masood, Shabana Rizvi, Anita Ali, Abida Sajid, Aisha Iftikhar, Shazia Batool, Lubna Dar, Shahenzad Sohail, Shazia Rasul, Shamsa Humayun, Rashida Sultana, Sofia Manzoor, Syeda Mazhar, Afshan Batool, Asia Nazir, Nasira Tasnim, Hajira Masood, Razia Khero, Neelam Surhio, Samana Aleem, Naila Israr, Saba Javed, Lubna Bashir, Samina Iqbal, Faiza Aleem, Rubina Sohail, Saima Iqbal, Samina Dojki, Alia Bano, Naseem Saba, Maimoona Hafeez, Nishat Akram, Riffat Shaheen, Haleema Hashmi, Sharmeen Arshad, Rubina Hussain, Sadia Khan, Nighat Shaheen, Safia Khalil, Pushpa 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, Isabirye Rebecca, Nayiga Annet, Nakirigya Nuulu, Elizabeth Nionzima, Rose Bwotya, Margret Nankya, Sarah Babirye, Joseph Ngonzi, Cesar Sanchez, 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, Victor Wanjohi, Bonface Musila, Kubasu Wekesa, Alex Nyakundi Bosire, Alice Ntem, Angeline Njoache, Alice Ashu, André Simo, Dorothy Keka, Kenfack Bruno, Amadou Ndouoya, Martin Saadio, Mesack Tchana, Odel Gwan, Pauline Assomo, Venantius Mutsu, Nji Eric, Pascal Foumane, Philemon Nsem, Jeanne Fouedjio, Ymele Fouelifack, Pierre Marie Tebeu, Georges Nko'ayissi, Eta Ngole Mbong, Wisal Nabag, Riham Desougi, Hadia Mustafa, Huida Eltaib, Taha Umbeli, Khalid Elfadl, Murwan Ibrahim, Abdalla Mohammed, Awadia Ali, Somia Abdelrahiem, Mohammed Musa, Khidir Awadalla, Samirra Ahmed, Mahdi Bushra, Omer Babiker, Hala Abdullahi, Mohamed Ahmed, Elhassan Safa, Huida Almardi, Duria Rayis, Saeed Abdelrahman Abdelgabar, Gillian Houghton, Andrew Sharpe, Jim Thornton, Nick Grace, Carys Smith, Kim Hinshaw, Dawn Edmundson, Paul Ayuk, Alison Bates, George Bugg, Joanne Wilkins, Clare Tower, Alysha Allibone, Eugene Oteng-Ntim, Ahmad Kazumari, Anna Danford, Matilda Ngarina, Muzdalifat Abeid, Khadija Mayumba, Magreth Zacharia, George Mtove, Leonard Madame, Anthony Massinde, Berno Mwambe, Rwakyendela Onesmo, Sebastian Kitengile Ganyaka, Shyam Gupta, Rabindra Bhatt, Ajay Agrawal, Pramila Pradhan, Nikita Dhakal, Punita Yadav, Gyanendra Karki, Bhola Ram Shrestha, Mwansa Lubeya, Jane Mumba, Willies Silwimba, Isaiah Hansingo, Noojiri Bopili, Ziche Makukula, Alexander Kawimbe, Mwansa Ketty Lubeya, Willard Mtambo, Mathew Ng'ambi, Saimir Cenameri, Ilir Tasha, Aferdita Kruja, Besnik Brahimaj, Armida Tola, Leon Kaza, 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, Ferdousi Chowdhury, Rokeya Begum, Farjana Basher, Nazlima Nargis, Abu Kholdun, Shahela Jesmin, Shrodha Paul, Hailemariam Segni, Getachew Ayana, William Haleke, Hassen Hussien, Fikre Geremew, Moussa Bambara, Adolphe Somé, Amadou Ly, Roamba Pabakba, Horace Fletcher, Leslie Samuels, Henry Opare-Addo, Roderick Larsen-Reindorf, Kwadwo Nyarko-Jectey, Glen Mola, Malts Wai, Magdy El Rahman, Wafaa Basta, Hussein Khamis, Maria Fernanda Escobar, Liliana Vallecilla, and Gabriel Essetchi Faye

Subjects
medicine.medical_specialty, Hysterectomy, business.industry, medicine.medical_treatment, Placebo-controlled study, General Medicine, 030204 cardiovascular system & hematology, Placebo, medicine.disease, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Relative risk, Anesthesia, Clinical endpoint, medicine, Caesarean section, Maternal death, 030212 general & internal medicine, business, Tranexamic acid, medicine.drug
Abstract

Background\ud 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.\ud \ud Methods\ud 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.\ud \ud Findings\ud 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.\ud \ud Interpretation\ud 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.\ud \ud Funding\ud London School of Hygiene & Tropical Medicine, Pfizer, UK Department of Health, Wellcome Trust, and Bill & Melinda Gates Foundation.

Published
2017
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