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1. Early warning systems for identifying severe maternal outcomes: findings from the WHO global maternal sepsis studyResearch in context

Author

Yamikani Chimwaza, Alexandra Hunt, Livia Oliveira-Ciabati, Laura Bonnett, Edgardo Abalos, Cristina Cuesta, João Paulo Souza, Mercedes Bonet, Vanessa Brizuela, David Lissauer, Mohammad Iqbal Aman, Bashir Noormal, Marisa Espinoza, Julia Pasquale, Charlotte Leroy, Kristien Roelens, Griet Vandenberghe, M. Christian Urlyss Agossou, Sourou Goufodji Keke, Christiane Tshabu Aguemon, Patricia Soledad Apaza Peralta, Víctor Conde Altamirano, Rosalinda Hernández Muñoz, José Guilherme Cecatti, Carolina Ribeiro do Valle, Vincent Batiene, Kadari Cisse, Henri Gautier Ouedraogo, Kannitha Cheang, Phirun Lam, Tung Rathavy, Elie Simo, Pierre-Marie Tebeu, Emah Irene Yakana, Javier Carvajal, María Fernanda Escobar, Paula Fernández, Lotte Berdiin Colmorn, Jens Langhoff-Roos, Wilson Mereci, Paola Vélez, Yasser Salah Eldin, Alaa Sultan, Alula M. Teklu, Dawit Worku, Richard Adanu, Philip Govule, Charles Noora Lwanga, William Enrique Arriaga Romero, María Guadalupe Flores Aceituno, Carolina Bustillo, Bredy Lara, Vijay Kumar, Vanita Suri, Sonia Trikha, Irene Cetin, Serena Donati, Carlo Personeni, Guldana Baimussanova, Saule Kabylova, Balgyn Sagyndykova, George Gwako, Alfred Osoti, Zahida Qureshi, Raisa Asylbasheva, Aigul Boobekova, Damira Seksenbaeva, Saad Eddine Itani, Meilė Minkauskienė, Diana Ramašauskaitė, Owen Chikhwaza, Luis Gadama, Eddie Malunga, Haoua Dembele, Hamadoun Sangho, Fanta Eliane Zerbo, Filiberto Dávila Serapio, Nazarea Herrera Maldonado, Juan I. Islas Castañeda, Tatiana Cauaus, Ala Curteanu, Victor Petrov, Yadamsuren Buyanjargal, Seded Khishgee, Bat-Erdene Lkhagvasuren, Amina Essolbi, Rachid Moulki, Zara Jaze, Arlete Mariano, Nafissa Bique Osman, Hla Mya Thway Einda, Thae Maung Maung, Khaing Nwe Tin, Tara Gurung, Amir Babu Shrestha, Sangeeta Shrestha, Kitty Bloemenkamp, Marcus J. Rijken, Thomas Van Den Akker, María Esther Estrada, Néstor J. Pavón Gómez, Olubukola Adesina, Chris Aimakhu, Bukola Fawole, Rizwana Chaudhri, Saima Hamid, M. Adnan Khan, María del Pilar Huatuco Hernández, Nelly M. Zavaleta Pimentel, Maria Lu Andal, Zenaida Dy Recidoro, Carolina Paula Martin, Mihaela Budianu, Lucian Pușcașiu, Léopold Diouf, Dembo Guirassy, Philippe Marc Moreira, Miroslav Borovsky, Ladislav Kovac, Alexandra Kristufkova, Sylvia Cebekhulu, Laura Cornelissen, Priya Soma-Pillay, Vicenç Cararach, Marta López, María José Vidal Benedé, Hemali Jayakody, Kapila Jayaratne, Dhammica Rowel, Wisal Nabag, Sara Omer, Victoria Tsoy, Urunbish Uzakova, Dilrabo Yunusova, Thitiporn Siriwachirachai, Thumwadee Tangsiriwatthana, Catherine Dunlop, Marian Knight, Jhon Roman, Gerardo Vitureira, Dinh Anh Tuan, Luong Ngoc Truong, Nghiem Thi Xuan Hanh, Mugove Madziyire, Thulani Magwali, Stephen Munjanja, Adama Baguiya, Mónica Chamillard, Seni Kouanda, Pisake Lumbiganon, Ashraf Nabhan, Ruta Nadisauskiene, Linda Bartlett, Fernando Bellissimo-Rodrigues, Shevin T. Jacob, Sadia Shakoor, Khalid Yunis, Liana Campodónico, Hugo Gamerro, Daniel Giordano, Fernando Althabe, and A. Metin Gülmezoglu

Subjects
Early warning systems, Sepsis, Maternal sepsis, Early identification, Severe maternal outcome, Medicine (General), R5-920
Abstract

Summary: Background: Infections and sepsis are leading causes of morbidity and mortality in women during pregnancy and the post-pregnancy period. Using data from the 2017 WHO Global Maternal Sepsis Study, we explored the use of early warning systems (EWS) in women at risk of sepsis-related severe maternal outcomes. Methods: On April 27, 2023, we searched the literature for EWS in clinical use or research in obstetric populations. We calculated the proportion of women for whom each existing EWS identified them as at risk for developing severe maternal outcomes by infection severity (complications and severe maternal outcomes). Sensitivity, specificity, positive and negative likelihood ratios, diagnostic odds ratios, and J statistics were calculated to assess EWS performance. Machine learning was used to test the diagnostic potential of routine maternal sepsis markers. Findings: 21 EWS were assessed in 2560 women from 46 countries with suspected or confirmed infections. The NICE Risk Stratification tool, Modified Shock Index, maternity Systemic Inflammatory Response Syndrome, and Early Maternal Infection Prompts scores had high sensitivity (88.1–97.5%) for identifying sepsis-related severe maternal outcomes. The quick Sequential Organ Failure Assessment (SOFA) in Pregnancy score and Obstetrically modified SOFA had high specificity (90.4–100%) for identifying women with sepsis-related severe maternal outcomes. Furthermore, combinations of sepsis markers had very low sensitivity and high specificity using machine learning. Interpretation: No score demonstrated enough diagnostic accuracy to be used alone to identify sepsis. However, obstetric—and sepsis-specific EWS performed better for early identification of maternal sepsis than non-obstetric and non-sepsis-specific scoring systems. There are limitations to applying EWS to real-world data, mainly due to the incompleteness of medical data that hinders EWS effectiveness. There is a need to continue developing and testing criteria for early identification of maternal sepsis. Funding: UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), WHO, Merck for Mothers, U.S. Agency for International Development, Wellcome Trust, and National Institute for Health and Care Research.

Published
2025
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2. Early evaluation of the ‘STOP SEPSIS!’ WHO Global Maternal Sepsis Awareness Campaign implemented for healthcare providers in 46 low, middle and high-income countries

Author

Marian Knight, José Guilherme Cecatti, Thae Maung Maung, Mercedes Bonet, Fernando Althabe, Joao Paulo Souza, Bouchra Assarag, Richard Adanu, Kristien Roelens, Kitty Bloemenkamp, Shevin T Jacob, Vijay Kumar, Jens Langhoff-Roos, Vanessa Brizuela, Rizwana Chaudhri, Griet Vandenberghe, Carla Lionela Trigo Romero, Edgardo Abalos, Adama Baguiya, Bukola Fawole, Pisake Lumbiganon, Meilė Minkauskienė, Ashraf Nabhan, Nafissa Bique Osman, Zahida P Qureshi, Mohammad Iqbal Aman, Bashir Noormal, Virginia Díaz, Marisa Espinoza, Julia Pasquale, Charlotte Leroy, M. Christian Urlyss Agossou, Sourou Goufodji Keke, Christiane Tshabu Aguemon, Víctor Conde Altamirano, Rosalinda Hernández Muñoz, Vincent Batiene, Kadari Cisse, Henri Gautier Ouedraogo, Cheang Kannitha, Lam Phirun, Tung Rathavy, Elie Simo, Pierre-Marie Tebeu, Emah Irene Yakana, Javier Carvajal, María Fernanda Escobar, Paula Fernández, Lotte Berdiin Colmorn, Wilson Mereci, Paola Vélez, Yasser Salah Eldin, Alaa Sultan, Abdulfetah Abdulkadir Abdosh, Alula M. Teklu, Dawit Worku Kassa, Philip Govule, Charles Noora Lwanga, Rigoberto Castro Bustillo, Bredy Lara, Vanita Suri, Sonia Trikha, Irene Cetin, Serena Donati, Carlo Personeni, Guldana Baimussanova, Saule Kabylova, Balgyn Sagyndykova, George Gwako, Alfred Osoti, Zahida Qureshi, Raisa Asylbasheva, Aigul Boobekova, Damira Seksenbaeva, Faysal El Kak, Saad Eddine Itani, Sabina Abou Malham, Diana Ramašauskaitė, Owen Chikhwaza, Luis Gadama, Eddie Malunga, Haoua Dembele, Hamadoun Sangho, Fanta Eliane Zerbo, Filiberto Dávila Serapio, Nazarea Herrera Maldonado, Tatiana Cauaus, Ala Curteanu, Victor Petrov, Yadamsuren Buyanjargal, Seded Khishgee, Bat-Erdene Lkhagvasuren, Amina Essolbi, Rachid Moulki, Zara Jaze, Arlete Mariano, Hla Mya Thway Einda, Khaing Nwe Tin, Tara Gurung, Amir Babu Shrestha, Sangeeta Shrestha, Marcus J. Rijken, Thomas Van DenAkker, María Esther Estrada, Olubukola Adesina, Chris Aimakhu, Saima Hamid, M. Adnan Khan, María del Pilar Huatuco Hernández, Nelly M Zavaleta Pimentel, Maria Lu Andal, Carolina Paula Martin, Zenaida Dy Recidoro, Mihaela Budianu, Lucian Pușcașiu, Léopold Diouf, Dembo Guirassy, Philippe Marc Moreira, Miroslav Borovsky, Ladislav Kovac, Alexandra Kristufkova, Sylvia Cebekhulu, Laura Cornelissen, Priya Soma-Pillay, Vicenç Cararach, Marta López, María José Vidal Benedé, Hemali Jayakody, Kapila Jayaratne, Dhammica Rowel, Mohamed Elsheikh, Wisal Nabag, Sara Omer, Victoria Tsoy, Urunbish Uzakova, Dilrabo Yunusova, Catherine Dunlop, David Lissauer, Aquilino M Pérez, Jhon Roman, Gerardo Vitureira, Dinh Anh Tuan, Luong Ngoc Truong, Nghiem Thi Xuan Hanh, Mugove Madziyire, Thulani Magwali, Stephen Munjanja, Mónica Chamillard, Seni Kouanda, Ruta Nadisauskiene, Linda Bartlett, Fernando Bellissimo-Rodrigues, Sadia Shakoor, Khalid Yunis, Liana Campodónico, Cristina Cuesta, Hugo Gamerro, Daniel Giordano, A Metin Gülmezoglu, Patricia Soledad Apaza Peralta, Carolina C Ribeiro do Valle, William Enrique Arriaga Romero, María Guadalupe Flores Aceituno, Thumwadee Tangsiriwatthana, Thitiporn Siriwachirachai, and Néstor J Pavón Gómez

Subjects
Medicine
Abstract

Objective To evaluate changes in awareness of maternal sepsis among healthcare providers resulting from the WHO Global Maternal Sepsis Study (GLOSS) awareness campaign.Design Independent sample precampaign/postcampaign through online and paper-based surveys available for over 30 days before campaign roll-out (pre) and after study data collection (post). Descriptive statistics were used for campaign recognition and exposure, and odds ratio (OR) and percentage change were calculated for differences in awareness, adjusting for confounders using multivariate logistic regression.Setting and participants Healthcare providers from 398 participating facilities in 46 low, middle and high-income countries.Intervention An awareness campaign to accompany GLOSS launched 3 weeks prior to data collection and lasting the entire study period (28 November 2017 to 15 January 2018) and beyond.Main outcome measures Campaign recognition and exposure, and changes in awareness.Results A total of 2188 surveys were analysed: 1155 at baseline and 1033 at postcampaign. Most survey respondents found the campaign materials helpful (94%), that they helped increase awareness (90%) and that they helped motivate to act differently (88%). There were significant changes with regard to: not having heard of maternal sepsis (−63.4% change, pre-OR/post-OR 0.35, 95% CI 0.18 to 0.68) and perception of confidence in making the right decisions with regard to maternal sepsis identification and management (7.3% change, pre-OR/post-OR 1.44, 95% CI 1.01 to 2.06).Conclusions Awareness raising campaigns can contribute to an increase in having heard of maternal sepsis and an increase in provider perception of confidence in making correct decisions. Offering the information to make accurate and timely decisions while promoting environments that enable self-confidence and support could improve maternal sepsis identification and management.

Published
2020
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3. Frequency and management of maternal infection in health facilities in 52 countries (GLOSS): a 1-week inception cohort study

Author

Mercedes Bonet, Vanessa Brizuela, Edgardo Abalos, Cristina Cuesta, Adama Baguiya, Mónica Chamillard, Bukola Fawole, Marian Knight, Seni Kouanda, Pisake Lumbiganon, Ashraf Nabhan, Ruta J Nadisauskiene, Abdulfetah Abdulkadir, Richard MK Adanu, Mohammad Iqbal Aman, William E. Arriaga Romero, Bouchra Assarag, Kitty W.M. Bloemenkamp, Aigul Boobekova, Mihaela A. Budianu, Vicenç Cararach, Rigoberto Castro, Sylvia Cebekhulu, José Guilherme Cecatti, Lotte Berdiin Colmorn, Ala Curteanu, Serena Donati, Hla Mya Thway Einda, Yasser Salah El Deen, Faysal El Kak, Mohamed Elsheikh, Maria F Escobar-Vidarte, Marisa Mabel Espinoza, María Ester Estrada, Luis Aaron Gadama, Sourou B Goufodji, Saima Hamid, Rosalinda Hernandez Munoz, Nazarea Herrera Maldonado, Kapila Jayaratne, Saule Kabylova, Alexandra Kristufkova, Vijay Kumar, David Lissauer, Wilson Mereci, Meile Minkauskiene, Philippe Moreira, Stephen Munjanja, Nafissa B. Osman, Henri Gautier Ouedraogo, Aquilino M. Perez, Julia Pasquale, Lucian Puscasiu, Zahida Qureshi, Zenaida Recidoro, Carolina C. Ribeiro-do-Valle, Dhammica Rowel, Hamadoun Sangho, Amir Babu Shrestha, Thitiporn Siriwachirachai, Pierre Marie Tebeu, Khaing Nwe Tin, Dinh Anh Tuan, Rathavy Tung, Griet Vandenberghe, Buyanjargal Yadamsuren, Dilrabo Yunusova, Nelly Zavaleta Pimentel, Bashir Noormal, Virginia Díaz, Charlotte Leroy, Kristien Roelens, M. Christian Urlyss Agossou, Christiane Tshabu Aguemon, Patricia Soledad Apaza Peralta, Víctor Conde Altamirano, Vincent Batiene, Kadari Cisse, Kannitha Cheang, Phirun Lam, Elie Simo, Emah Irene Yakana, Javier Carvajal, Paula Fernández, Jens Langhoff-Roos, Paola Vélez, Alaa Sultan, Alula M. Teklu, Dawit Worku, Philip Govule, Charles Noora Lwanga, María Guadalupe Flores Aceituno, Carolina Bustillo, Bredy Lara, Vanita Suri, Sonia Trikha, Irene Cetin, Carlo Personeni, Guldana Baimussanova, Balgyn Sagyndykova, George Gwako, Alfred Osoti, Raisa Asylbasheva, Damira Seksenbaeva, Saad Eddine Itani, Sabina Abou Malham, Diana Ramašauskaitė, Owen Chikhwaza, Eddie Malunga, Haoua Dembele, Fanta Eliane Zerbo, Filiberto Dávila Serapio, Juan I. Islas Castañeda, Tatiana Cauaus, Victor Petrov, Seded Khishgee, Bat-Erdene Lkhagvasuren, Amina Essolbi, Rachid Moulki, Zara Jaze, Arlete Mariano, Thae Maung Maung, Tara Gurung, Sangeeta Shrestha, Marcus J. Rijken, Thomas Van Den Akker, María Esther Estrada, Néstor J. Pavón Gómez, Olubukola Adesina, Chris Aimakhu, Rizwana Chaudhri, M. Adnan Khan, María del Pilar Huatuco Hernández, Maria Lu Andal, Carolina Paula Martin, Léopold Diouf, Dembo Guirassy, Miroslav Borovsky, Ladislav Kovac, Laura Cornelissen, Priya Soma-Pillay, Marta López, María José Vidal Benedé, Hemali Jayakody, Wisal Nabag, Sara Omer, Victoria Tsoy, Urunbish Uzakova, Thumwadee Tangsiriwatthana, Catherine Dunlop, Jhon Roman, Gerardo Vitureira, Luong Ngoc Truong, Nghiem Thi Xuan Hanh, Mugove Madziyire, Thulani Magwali, Linda Bartlett, Fernando Bellissimo-Rodrigues, Shevin T. Jacob, Sadia Shakoor, Khalid Yunis, Liana Campodónico, Hugo Gamerro, Daniel Giordano, Fernando Althabe, A. Metin Gülmezoglu, and João Paulo Souza

Subjects
Public aspects of medicine, RA1-1270
Abstract

Summary: Background: Maternal infections are an important cause of maternal mortality and severe maternal morbidity. We report the main findings of the WHO Global Maternal Sepsis Study, which aimed to assess the frequency of maternal infections in health facilities, according to maternal characteristics and outcomes, and coverage of core practices for early identification and management. Methods: We did a facility-based, prospective, 1-week inception cohort study in 713 health facilities providing obstetric, midwifery, or abortion care, or where women could be admitted because of complications of pregnancy, childbirth, post-partum, or post-abortion, in 52 low-income and middle-income countries (LMICs) and high-income countries (HICs). We obtained data from hospital records for all pregnant or recently pregnant women hospitalised with suspected or confirmed infection. We calculated ratios of infection and infection-related severe maternal outcomes (ie, death or near-miss) per 1000 livebirths and the proportion of intrahospital fatalities across country income groups, as well as the distribution of demographic, obstetric, clinical characteristics and outcomes, and coverage of a set of core practices for identification and management across infection severity groups. Findings: Between Nov 28, 2017, and Dec 4, 2017, of 2965 women assessed for eligibility, 2850 pregnant or recently pregnant women with suspected or confirmed infection were included. 70·4 (95% CI 67·7–73·1) hospitalised women per 1000 livebirths had a maternal infection, and 10·9 (9·8–12·0) women per 1000 livebirths presented with infection-related (underlying or contributing cause) severe maternal outcomes. Highest ratios were observed in LMICs and the lowest in HICs. The proportion of intrahospital fatalities was 6·8% among women with severe maternal outcomes, with the highest proportion in low-income countries. Infection-related maternal deaths represented more than half of the intrahospital deaths. Around two-thirds (63·9%, n=1821) of the women had a complete set of vital signs recorded, or received antimicrobials the day of suspicion or diagnosis of the infection (70·2%, n=1875), without marked differences across severity groups. Interpretation: The frequency of maternal infections requiring management in health facilities is high. Our results suggest that contribution of direct (obstetric) and indirect (non-obstetric) infections to overall maternal deaths is greater than previously thought. Improvement of early identification is urgently needed, as well as prompt management of women with infections in health facilities by implementing effective evidence-based practices. Funding: UNDP–UNFPA–UNICEF–WHO–World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO, Merck for Mothers, and United States Agency for International Development.

Published
2020
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4. Availability of facility resources and services and infection-related maternal outcomes in the WHO Global Maternal Sepsis Study : a cross-sectional study

Author

Vanessa Brizuela, Cristina Cuesta, Gino Bartolelli, Abdulfetah Abdulkadir Abdosh, Sabina Abou Malham, Bouchra Assarag, Rigoberto Castro Banegas, Virginia Díaz, Faysal El-Kak, Mohamed El Sheikh, Aquilino M Pérez, João Paulo Souza, Mercedes Bonet, Edgardo Abalos, Rigoberto Castro, Faysal El Kak, Mohamed Elsheikh, Aquilino M. Pérez, Mohammad Iqbal Aman, Bashir Noormal, Marisa Espinoza, Julia Pasquale, Charlotte Leroy, Kristien Roelens, Griet Vandenberghe, M. Christian Urlyss Agossou, Sourou Goufodji Keke, Christiane Tshabu Aguemon, Patricia Soledad Apaza Peralta, Víctor Conde Altamirano, Rosalinda Hernández Muñoz, José Guilherme Cecatti, Carolina Ribeiro do Valle, Vincent Batiene, Kadari Cisse, Henri Gautier Ouedraogo, Kannitha Cheang, Phirun Lam, Tung Rathavy, Elie Simo, Pierre-Marie Tebeu, Emah Irene Yakana, Javier Carvajal, María Fernanda Escobar, Paula Fernández, Lotte Berdiin Colmorn, Jens Langhoff-Roos, Wilson Mereci, Paola Vélez, Yasser Salah Eldin, Alaa Sultan, Alula M. Teklu, Dawit Worku, Richard Adanu, Philip Govule, Charles Noora Lwanga, William Enrique Arriaga Romero, María Guadalupe Flores Aceituno, Carolina Bustillo, Bredy Lara, Vijay Kumar, Vanita Suri, Sonia Trikha, Irene Cetin, Serena Donati, Carlo Personeni, Guldana Baimussanova, Saule Kabylova, Balgyn Sagyndykova, George Gwako, Alfred Osoti, Zahida Qureshi, Raisa Asylbasheva, Aigul Boobekova, Damira Seksenbaeva, Saad Eddine Itani, Meilė Minkauskienė, Diana Ramašauskaitė, Owen Chikhwaza, Luis Gadama, Eddie Malunga, Haoua Dembele, Hamadoun Sangho, Fanta Eliane Zerbo, Filiberto Dávila Serapio, Nazarea Herrera Maldonado, Juan I. Islas Castañeda, Tatiana Cauaus, Ala Curteanu, Victor Petrov, Yadamsuren Buyanjargal, Seded Khishgee, Bat-Erdene Lkhagvasuren, Amina Essolbi, Rachid Moulki, Zara Jaze, Arlete Mariano, Nafissa Bique Osman, Hla Mya Thway Einda, Thae Maung Maung, Khaing Nwe Tin, Tara Gurung, Amir Babu Shrestha, Sangeeta Shrestha, Kitty Bloemenkamp, Marcus J. Rijken, Thomas Van Den Akker, María Esther Estrada, Néstor J. Pavón Gómez, Olubukola Adesina, Chris Aimakhu, Bukola Fawole, Rizwana Chaudhri, Saima Hamid, M. Adnan Khan, María del Pilar Huatuco Hernández, Nelly M. Zavaleta Pimentel, Maria Lu Andal, Zenaida Dy Recidoro, Carolina Paula Martin, Mihaela Budianu, Lucian Puşcaşiu, Léopold Diouf, Dembo Guirassy, Philippe Marc Moreira, Miroslav Borovsky, Ladislav Kovac, Alexandra Kristufkova, Sylvia Cebekhulu, Laura Cornelissen, Priya Soma-Pillay, Vicenç Cararach, Marta López, María José Vidal Benedé, Hemali Jayakody, Kapila Jayaratne, Dhammica Rowel, Wisal Nabag, Sara Omer, Victoria Tsoy, Urunbish Uzakova, Dilrabo Yunusova, Thitiporn Siriwachirachai, Thumwadee Tangsiriwatthana, Catherine Dunlop, Marian Knight, David Lissauer, Jhon Roman, Gerardo Vitureira, Dinh Anh Tuan, Luong Ngoc Truong, Nghiem Thi Xuan Hanh, Mugove Madziyire, Thulani Magwali, Stephen Munjanja, Adama Baguiya, Mónica Chamillard, Seni Kouanda, Pisake Lumbiganon, Ashraf Nabhan, Ruta Nadisauskiene, Linda Bartlett, Fernando Bellissimo-Rodrigues, Shevin T. Jacob, Sadia Shakoor, Khalid Yunis, Liana Campodónico, Hugo Gamerro, Daniel Giordano, Fernando Althabe, A. Metin Gülmezoglu, and Obstetrics and Gynaecology

Subjects
medicine.medical_specialty, Cross-sectional study, Psychological intervention, Global Health, World Health Organization, Odds, Pregnancy, medicine, Medicine and Health Sciences, Infection control, Childbirth, Humans, Prospective Studies, Pregnancy Complications, Infectious, Poverty, business.industry, Medical record, MORTALITY, General Medicine, Odds ratio, Articles, medicine.disease, Cross-Sectional Studies, Treatment Outcome, Family medicine, Health Resources, Female, Health Facilities, business
Abstract

Background Infections are among the leading causes of maternal mortality and morbidity. The Global Maternal Sepsis and Neonatal Initiative, launched in 2016 by WHO and partners, sought to reduce the burden of maternal infections and sepsis and was the basis upon which the Global Maternal Sepsis Study (GLOSS) was implemented in 2017. In this Article, we aimed to describe the availability of facility resources and services and to analyse their association with maternal outcomes. Methods GLOSS was a facility-based, prospective, 1-week inception cohort study implemented in 713 health-care facilities in 52 countries and included 2850 hospitalised pregnant or recently pregnant women with suspected or confirmed infections. All women admitted for or in hospital with suspected or confirmed infections during pregnancy, childbirth, post partum, or post abortion at any of the participating facilities between Nov 28 and Dec 4 were eligible for inclusion. In this study, we included all GLOSS participating facilities that collected facility-level data (446 of 713 facilities). We used data obtained from individual forms completed for each enrolled woman and their newborn babies by trained researchers who checked the medical records and from facility forms completed by hospital administrators for each participating facility. We described facilities according to country income level, compliance with providing core clinical interventions and services according to women's needs and reported availability, and severity of infection-related maternal outcomes. We used a logistic multilevel mixed model for assessing the association between facility characteristics and infection-related maternal outcomes. Findings We included 446 facilities from 46 countries that enrolled 2560 women. We found a high availability of most services and resources needed for obstetric care and infection prevention. We found increased odds for severe maternal outcomes among women enrolled during the post-partum or post-abortion period from facilities located in low-income countries (adjusted odds ratio 1middot84 [95% CI 1middot05-3middot22]) and among women enrolled during pregnancy or childbirth from non-urban facilities (adjusted odds ratio 2middot44 [1middot02-5middot85]). Despite compliance being high overall, it was low with regards to measuring respiratory rate (85 [24%] of 355 facilities) and measuring pulse oximetry (184 [57%] of 325 facilities). Interpretation While health-care facilities caring for pregnant and recently pregnant women with suspected or confirmed infections have access to a wide range of resources and interventions, worse maternal outcomes are seen among recently pregnant women located in low-income countries than among those in higher-income countries; this trend is similar for pregnant women. Compliance with cost-effective clinical practices and timely care of women with particular individual characteristics can potentially improve infection-related maternal outcomes. Funding UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO, Merck for Mothers, and US Agency for International Development. Copyright (c) 2021 World Health Organization; licensee Elsevier. This is an Open Access article under the CC BY 3.0 IGO license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products, or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.

Published
2021

6. 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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