7 results on '"Saturday Etuk"'
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2. The Influence of Threatened Miscarriage on Pregnancy Outcomes: A Retrospective Cohort Study in a Nigerian Tertiary Hospital
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Ubong B, Akpan, Chinyere J, Akpanika, Udeme, Asibong, Kazeem, Arogundade, Adaolisa E, Nwagbata, and Saturday, Etuk
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General Engineering - Abstract
Pregnancies complicated by threatened miscarriage (TM) may be associated with adverse pregnancy outcomes. The objective of this study was to compare the differences in pregnancy outcomes between the women who experienced TM and asymptomatic controls.This was a 10-year retrospective review. Case records of 117 women who were managed for TM from January 1, 2010, to December 31, 2019, were retrieved and studied. The control group was developed from an equal number of asymptomatic clients matched for age, parity, and BMI who were receiving antenatal care (ANC) during the same period. Data on demography, clinical and ultrasound findings, treatment, and pregnancy outcomes were retrieved and analyzed.Spontaneous abortion rate of 13.7% was recorded among the study group compared with 3.4% in the control (P-value [p] = 0.005, odds ratio [OR]: 4.475; 95% confidence interval [CI]: 1.445 - 13.827). Women with TM had higher odds for placenta previa (p = 0.049, OR: 4.77, 95% CI: 2.19 - 23.04), premature rupture of membranes (PROM) (p = 0.028, OR: 1.918, 95% CI: 1.419 - 2.592), postpartum hemorrhage (PPH) (p = 0.001, OR: 2.66, 95% CI: 20.8 - 8.94), and preterm birth (OR: 2.5, 95% CI: 1.75 - 3.65). They were also more likely to undergo cesarean section (p = 0.020, OR: 1.70, 95% CI: 1.053 - 2.964). There was no statistically significant difference in their infants' mean birth weight (3.113 ± 0.585kg for the TM group and 3.285± 0.536kg for the control, P=0.074). Other maternal and perinatal complications were similar. Admission for bed rest significantly improved fetal survival. Women who were not admitted for bed rest had higher odds of pregnancy loss (OR: 3.443, 95% CI: 1.701-7.99). Other treatment plans did not significantly contribute to a positive outcome.Threatened miscarriage is a significant threat to fetal survival and may increase the risk for operative delivery. Bed rest improves the live birth rate.
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- 2022
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3. Effects of prenatal exposure to maternal COVID-19 and perinatal care on neonatal outcome: results from the INTERCOVID Multinational Cohort Study
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Francesca Giuliani, Daniel Oros, Robert B. Gunier, Sonia Deantoni, Stephen Rauch, Roberto Casale, Ricardo Nieto, Enrico Bertino, Albertina Rego, Camilla Menis, Michael G. Gravett, Massimo Candiani, Philippe Deruelle, Perla K. García-May, Mohak Mhatre, Mustapha Ado Usman, Sherief Abd-Elsalam, Saturday Etuk, Raffaele Napolitano, Becky Liu, Federico Prefumo, Valeria Savasi, Marynéa Silva Do Vale, Eric Baafi, Shabina Ariff, Nerea Maiz, Muhammad Baffah Aminu, Jorge Arturo Cardona-Perez, Rachel Craik, Gabriela Tavchioska, Babagana Bako, Caroline Benski, Fatimah Hassan-Hanga, Mónica Savorani, Loïc Sentilhes, Maria Carola Capelli, Ken Takahashi, Carmen Vecchiarelli, Satoru Ikenoue, Ramachandran Thiruvengadam, Constanza P. Soto Conti, Irene Cetin, Vincent Bizor Nachinab, Ernawati Ernawati, Eduardo A. Duro, Alexey Kholin, Jagjit Singh Teji, Sarah Rae Easter, Laurent J. Salomon, Adejumoke Idowu Ayede, Rosa Maria Cerbo, Josephine Agyeman-Duah, Paola Roggero, Brenda Eskenazi, Ana Langer, Zulfiqar A. Bhutta, Stephen H. Kennedy, Aris T. Papageorghiou, and Jose Villar
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breastfeeding ,Infectious Disease Transmission ,morbidity ,Reproductive health and childbirth ,neurologic outcome ,Low Birth Weight and Health of the Newborn ,Cohort Studies ,small for gestational age ,COVID-19 Testing ,newborn ,Pregnancy ,Infant Mortality ,neonatal outcomes ,Vertical ,infections ,Pregnancy Complications, Infectious ,neonatal intensive care unit admission ,Child ,Pediatric ,rooming-in ,Infectious ,respiratory symptoms ,Pregnancy Outcome ,Obstetrics and Gynecology ,cohort ,COVID-19 ,SARS-CoV-2 ,SARS-CoV-2 exposure ,birthweight ,cesarean delivery ,feeding problems ,hospital stay ,intrauterine growth restriction ,mortality ,multicenter study ,neonate ,perinatal practices ,preeclampsia ,pregnancy ,preterm birth ,respiratory support ,risk ratio ,skin-to-skin ,Perinatal Care ,Prenatal Exposure Delayed Effects ,Premature Birth ,Female ,Pediatric Research Initiative ,Paediatrics and Reproductive Medicine ,Clinical Research ,Preterm ,Humans ,Conditions Affecting the Embryonic and Fetal Periods ,Obstetrics & Reproductive Medicine ,Prevention ,Contraception/Reproduction ,Infant, Newborn ,Infant ,Perinatal Period - Conditions Originating in Perinatal Period ,Infectious Disease Transmission, Vertical ,Pregnancy Complications ,Good Health and Well Being - Abstract
Background: The effect of COVID-19 in pregnancy on maternal outcomes and its association with preeclampsia and gestational diabetes mellitus have been reported; however, a detailed understanding of the effects of maternal positivity, delivery mode, and perinatal practices on fetal and neonatal outcomes is urgently needed. Objective: To evaluate the impact of COVID-19 on fetal and neonatal outcomes and the role of mode of delivery, breastfeeding, and early neonatal care practices on the risk of mother-to-child transmission. Study Design: In this cohort study that took place from March 2020 to March 2021, involving 43 institutions in 18 countries, 2 unmatched, consecutive, unexposed women were concomitantly enrolled immediately after each infected woman was identified, at any stage of pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed up until hospital discharge. COVID-19 in pregnancy was determined by laboratory confirmation and/or radiological pulmonary findings or ≥2 predefined COVID-19 symptoms. The outcome measures were indices of neonatal and perinatal morbidity and mortality, neonatal positivity and its correlation with mode of delivery, breastfeeding, and hospital neonatal care practices. Results: A total of 586 neonates born to women with COVID-19 diagnosis and 1535 neonates born to women without COVID-19 diagnosis were enrolled. Women with COVID-19 diagnosis had a higher rate of cesarean delivery (52.8% vs 38.5% for those without COVID-19 diagnosis, P14 days). Among neonates born to mothers with COVID-19 diagnosis, birth via cesarean delivery was a risk factor for testing positive for COVID-19 (odds ratio, 2.4; 95% confidence interval, 1.2–4.7), even when severity of maternal conditions was considered and after multivariable logistic analysis. In the subgroup of neonates born to women with COVID-19 diagnosis, the outcomes worsened when the neonate also tested positive, with higher rates of neonatal intensive care unit admission, fever, gastrointestinal and respiratory symptoms, and death, even after adjusting for prematurity. Breastfeeding by mothers with COVID-19 diagnosis and hospital neonatal care practices, including immediate skin-to-skin contact and rooming-in, were not associated with an increased risk of newborn positivity. Conclusion: In this multinational cohort study, COVID-19 in pregnancy was associated with increased maternal and neonatal complications. Cesarean delivery was significantly associated with newborn COVID-19 diagnosis. Vaginal delivery should be considered the safest mode of delivery if obstetrical and health conditions allow it. Mother-to-child skin-to-skin contact, rooming-in, and direct breastfeeding were not risk factors for newborn COVID-19 diagnosis, thus well-established best practices can be continued among women with COVID-19 diagnosis.
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- 2022
4. Diabetes mellitus, maternal adiposity, and insulin-dependent gestational diabetes are associated with COVID-19 in pregnancy: the INTERCOVID study
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Brenda Eskenazi, Stephen Rauch, Enrico Iurlaro, Robert B. Gunier, Albertina Rego, Michael G. Gravett, Paolo Ivo Cavoretto, Philippe Deruelle, Perla K. García-May, Mohak Mhatre, Mustapha Ado Usman, Mohamed Elbahnasawy, Saturday Etuk, Raffaele Napolitano, Sonia Deantoni, Becky Liu, Federico Prefumo, Valeria Savasi, Patrícia F. Marques, Eric Baafi, Ghulam Zainab, Ricardo Nieto, Berta Serrano, Muhammad Baffah Aminu, Jorge Arturo Cardona-Perez, Rachel Craik, Adele Winsey, Gabriela Tavchioska, Babagana Bako, Daniel Oros, Caroline Benski, Hadiza Galadanci, Mónica Savorani, Manuela Oberto, Loïc Sentilhes, Milagros Risso, Ken Takahashi, Carmen Vecciarelli, Satoru Ikenoue, Anil K. Pandey, Constanza P. Soto Conti, Irene Cetin, Vincent Bizor Nachinab, Ernawati Ernawati, Eduardo A. Duro, Alexey Kholin, Michelle L. Firlit, Sarah Rae Easter, Joanna Sichitiu, Yetunde John-Akinola, Roberto Casale, Hellas Cena, Josephine Agyeman-Duah, Paola Roggero, Ana Langer, Zulfiqar A. Bhutta, Stephen H. Kennedy, Jose Villar, and Aris T. Papageorghiou
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Adult ,obesity ,Adolescent ,body mass index ,Maternal ,Reproductive health and childbirth ,Obesity, Maternal ,Paediatrics and Reproductive Medicine ,COVID-19 Testing ,Pregnancy ,Clinical Research ,COVID-19 ,diabetes mellitus ,gestational diabetes mellitus ,overweight ,pregnancy ,SARS-CoV-2 ,Diabetes Mellitus ,Humans ,Insulin ,Obstetrics & Reproductive Medicine ,Gestational diabetes ,Metabolic and endocrine ,Adiposity ,Nutrition ,Original Research: Obstetrics ,Prevention ,Diabetes ,Pregnancy Outcome ,Obstetrics and Gynecology ,Diabetes, Gestational ,Diabetes Mellitus, Type 1 ,Good Health and Well Being ,Gestational ,Female ,Type 1 - Abstract
Background Among nonpregnant individuals, diabetes mellitus and high body mass index increase the risk of COVID-19 and its severity. Objective This study aimed to determine whether diabetes mellitus and high body mass index are risk factors for COVID-19 in pregnancy and whether gestational diabetes mellitus is associated with COVID-19 diagnosis. Study Design INTERCOVID was a multinational study conducted between March 2020 and February 2021 in 43 institutions from 18 countries, enrolling 2184 pregnant women aged ≥18 years; a total of 2071 women were included in the analyses. For each woman diagnosed with COVID-19, 2 nondiagnosed women delivering or initiating antenatal care at the same institution were also enrolled. The main exposures were preexisting diabetes mellitus, high body mass index (overweight or obesity was defined as a body mass index ≥25 kg/m2), and gestational diabetes mellitus in pregnancy. The main outcome was a confirmed diagnosis of COVID-19 based on a real-time polymerase chain reaction test, antigen test, antibody test, radiological pulmonary findings, or ≥2 predefined COVID-19 symptoms at any time during pregnancy or delivery. Relationships of exposures and COVID-19 diagnosis were assessed using generalized linear models with a Poisson distribution and log link function, with robust standard errors to account for model misspecification. Furthermore, we conducted sensitivity analyses: (1) restricted to those with a real-time polymerase chain reaction test or an antigen test in the last week of pregnancy, (2) restricted to those with a real-time polymerase chain reaction test or an antigen test during the entire pregnancy, (3) generating values for missing data using multiple imputation, and (4) analyses controlling for month of enrollment. In addition, among women who were diagnosed with COVID-19, we examined whether having gestational diabetes mellitus, diabetes mellitus, or high body mass index increased the risk of having symptomatic vs asymptomatic COVID-19. Results COVID-19 was associated with preexisting diabetes mellitus (risk ratio, 1.94; 95% confidence interval, 1.55–2.42), overweight or obesity (risk ratio, 1.20; 95% confidence interval, 1.06–1.37), and gestational diabetes mellitus (risk ratio, 1.21; 95% confidence interval, 0.99–1.46). The gestational diabetes mellitus association was specifically among women requiring insulin, whether they were of normal weight (risk ratio, 1.79; 95% confidence interval, 1.06–3.01) or overweight or obese (risk ratio, 1.77; 95% confidence interval, 1.28–2.45). A somewhat stronger association with COVID-19 diagnosis was observed among women with preexisting diabetes mellitus, whether they were of normal weight (risk ratio, 1.93; 95% confidence interval, 1.18–3.17) or overweight or obese (risk ratio, 2.32; 95% confidence interval, 1.82–2.97). When the sample was restricted to those with a real-time polymerase chain reaction test or an antigen test in the week before delivery or during the entire pregnancy, including missing variables using imputation or controlling for month of enrollment, the observed associations were comparable. Conclusion Diabetes mellitus and overweight or obesity were risk factors for COVID-19 diagnosis in pregnancy, and insulin-dependent gestational diabetes mellitus was associated with the disease. Therefore, it is essential that women with these comorbidities are vaccinated.
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- 2022
5. Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals
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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
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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).
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- 2021
6. Incidence and Obstetric Outcome of Teenage Pregnancies at a Tertiary Hospital in Southern Nigeria
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Mbereobong Saturday Etuk Etuk
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medicine.medical_specialty ,business.industry ,Obstetrics ,Incidence (epidemiology) ,Medicine ,business ,Outcome (game theory) - Published
- 2020
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7. 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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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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