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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Antenatal dexamethasone for early preterm birth in low-resource countries
New England Journal of Medicine, Volume 383, No. 26, Year 2020
Notification
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Description
BACKGROUND The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. METHODS We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale. RESULTS A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P=0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P=0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection. © 2020 Massachusetts Medical Society.
Authors & Co-Authors
Oladapo, Olufemi Taiwo
Switzerland, Geneva
Organisation Mondiale de la Santé
Vogel, Joshua P.
Switzerland, Geneva
Organisation Mondiale de la Santé
Piaggio, Gilda Gp
Switzerland, Geneva
Organisation Mondiale de la Santé
Nguyen, My Huong
Switzerland, Geneva
Organisation Mondiale de la Santé
Althabe, Fernando A.
Switzerland, Geneva
Organisation Mondiale de la Santé
Gülmezoglu, Ahmet Metin
Switzerland, Geneva
Organisation Mondiale de la Santé
Bahl, Rajiv
Switzerland, Geneva
Organisation Mondiale de la Santé
Rao, Suman Padubidri Nanyam
Switzerland, Geneva
Organisation Mondiale de la Santé
de Costa, Ayesha
Switzerland, Geneva
Organisation Mondiale de la Santé
Gupta, Shuchita
Switzerland, Geneva
Organisation Mondiale de la Santé
Baqui, Abdullah Hel
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Khanam, Rasheda
United States, Baltimore
Johns Hopkins Bloomberg School of Public Health
Shahidullah, Mohammod M.
Bangladesh, Dhaka
Bangabandhu Sheikh Mujib Medical University
Chowdhury, Saleha Begum
Bangladesh, Dhaka
Bangabandhu Sheikh Mujib Medical University
Ahmed, Salahuddin K.
Unknown Affiliation
Begum, Nazma A.
Unknown Affiliation
Roy, Arunangshu Dutta
Unknown Affiliation
Shahed, M. A.
Unknown Affiliation
Jaben, Iffat Ara
Unknown Affiliation
Yasmin, Farida
Unknown Affiliation
Mozibur Rahman, M.
Unknown Affiliation
Ara, Anjuman
Unknown Affiliation
Khatoon, Soofia
Unknown Affiliation
Ara, G.
Bangladesh, Dhaka
Enam Medical College and Hospital
Akter, Shaheen
Bangladesh, Dhaka
Enam Medical College and Hospital
Akhter, Nasreen
Bangladesh, Bangladesh
Sylhet Muhammad Ataul Gani Osmani Medical College Hospital
Dey, Probhat Ranjan
Bangladesh, Bangladesh
Sylhet Muhammad Ataul Gani Osmani Medical College Hospital
Abdus Sabur, M.
Bangladesh, Bangladesh
Jalalabad Ragib-rabeya Medical College Hospital
Azad, Mohammad Tarek
Bangladesh, Bangladesh
Jalalabad Ragib-rabeya Medical College Hospital
Choudhury, Shahana Ferdous
India, Sylhet, Bangladesh
Sylhet Women's Medical College Hospital
Matin, M. A.
India, Sylhet, Bangladesh
Sylhet Women's Medical College Hospital
Goudar, Shivaprasad S.
Unknown Affiliation
Dhaded, Sangappa Mallappa
Unknown Affiliation
Metgud, Mrityunjay C.
Unknown Affiliation
Pujar, Yeshita V.
Unknown Affiliation
Somannavar, Manjunath Somappa
Unknown Affiliation
Vernekar, Sunil S.
Unknown Affiliation
Herekar, Veena R.
Unknown Affiliation
Bidri, Shailaja
India, Bijapur
Blde Deemed to be University
Mathapati, Sangamesh S.
India, Bijapur
Blde Deemed to be University
Patil, Preeti G.
India, Bijapur
Blde Deemed to be University
Patil, M. M.
India, Bijapur
Blde Deemed to be University
Gudadinni, Muttu R.
India, Bijapur
Blde Deemed to be University
Bijapure, Hidaytullah R.
India, Bijapur
Blde Deemed to be University
Mallapur, Ashalata A.
India, Bagalkot
S. Nijalingappa Medical College
Katageri, Geetanjali Mahagundappa
India, Bagalkot
S. Nijalingappa Medical College
Chikkamath, Sumangala B.
India, Bagalkot
S. Nijalingappa Medical College
Yelamali, Bhuvaneshwari C.
India, Bagalkot
S. Nijalingappa Medical College
Pol, Ramesh R.
India, Bagalkot
S. Nijalingappa Medical College
Misra, Sujata S.
India, Cuttak
Srirama Chandra Bhanja Medical College and Hospital
Das, Leena B.
India, Cuttak
Srirama Chandra Bhanja Medical College and Hospital
Nanda, Saumya S.
India, Cuttak
Srirama Chandra Bhanja Medical College and Hospital
Nayak, Rashmita Binod
India, Cuttak
Srirama Chandra Bhanja Medical College and Hospital
Singh, Bipsha S.
India, Cuttak
Srirama Chandra Bhanja Medical College and Hospital
Qureshi, Zahida P.
Kenya, Nairobi
University of Nairobi
Were, Fred Nabwire
Kenya, Nairobi
University of Nairobi
Osoti, Alfred Onyango
Kenya, Nairobi
University of Nairobi
Gwako, George N.
Kenya, Nairobi
University of Nairobi
Laving, Ahmed M.R.
Kenya, Nairobi
University of Nairobi
Kinuthia, John
Kenya, Nairobi
Kenyatta National Hospital
Mohamed, Hafsa
Kenya, Mombasa
Coast Provincial General Hospital, Kenya
Aliyan, Nawal
Kenya, Mombasa
Coast Provincial General Hospital, Kenya
Barassa, Adelaide
Kenya, Nakuru
Nakuru Level V Hospital
Kibaru, Elizabeth Gathoni
Kenya, Nakuru
Nakuru Level V Hospital
Mbuga, Margaret
Kenya, Kiambu
Kiambu Level 5 Hospital
Thuranira, Lydia
Kenya, Kiambu
Kiambu Level 5 Hospital
Githua, Njoroge John
Kenya, Thika
Thika Level 5 Hospital
Lusweti, Bernadine
Kenya, Thika
Thika Level 5 Hospital
Ayede, Adejumoke Idowu
Nigeria, Ibadan
University of Ibadan
Nigeria, Ibadan
College Hospital
Falade, Adegoke Gbadegesin
Nigeria, Ibadan
University of Ibadan
Nigeria, Ibadan
College Hospital
Adesina, Olubukola Adeponle
Nigeria, Ibadan
University of Ibadan
Nigeria, Ibadan
College Hospital
Agunloye, Atinuke M.
Nigeria, Ibadan
University of Ibadan
Nigeria, Ibadan
College Hospital
Iyiola, Oluwatosin O.
Nigeria, Ibadan
University of Ibadan
Nigeria, Ibadan
College Hospital
Sanni, Wilfred
Nigeria, Kubwa
Kubwa General Hospital
Ejinkeonye, Ifeyinwa K.
Nigeria, Kubwa
Kubwa General Hospital
Idris, Hadiza Abdulaziz
Nigeria, Nyanya
Nyanya General Hospital
Okoli, Chinyere V.
Nigeria, Nyanya
Nyanya General Hospital
Irinyenikan, Theresa Azonima
Nigeria, Abuja
State Specialist Hospital
Olubosede, Omolayo Adebukola
Nigeria, Abuja
State Specialist Hospital
Bello, Olaseinde
Nigeria, Abuja
State Specialist Hospital
Omololu, Olufemi M.
Nigeria, Akure
Lagos Island Maternity Hospital
Olutekunbi, Olanike Abosede
Nigeria, Akure
Lagos Island Maternity Hospital
Akintan, Adesina Lawrence
Nigeria, Ondo
Mother and Child Hospital
Owa, Olorunfemi Oludele
Nigeria, Ondo
Mother and Child Hospital
Oluwafemi, Rosena Olubanke
Nigeria, Ondo
Mother and Child Hospital
Eniowo, Ireti Patricia
Nigeria, Ondo
Mother and Child Hospital
Fabamwo, Adetokunbo Olusegun
Nigeria, Lagos
Lagos State University Teaching Hospital
Disu, Elizabeth Aruma
Nigeria, Lagos
Lagos State University Teaching Hospital
Agbara, Joy O.
Nigeria, Lagos
Lagos State University Teaching Hospital
Adejuyigbe, Ebunoluwa Aderonke
Nigeria, Ife
Obafemi Awolowo University
Kuti, Oluwafemi O.
Nigeria, Ife
Obafemi Awolowo University
Anyabolu, Henry Chineme
Nigeria, Ife
Obafemi Awolowo University
Awowole, Ibraheem Olayemi
Nigeria, Ife
Obafemi Awolowo University
Fehintola, Akintunde Olusegun
Nigeria, Ife
Obafemi Awolowo University
Kuti, Bankole Peter
Nigeria, Ife
Obafemi Awolowo University
Isah, Anthony Dennis
Nigeria, Abuja
University of Abuja
Olateju, Eyinade Kudirat
Nigeria, Abuja
University of Abuja
Abiodun, Olusanya
Nigeria, Abeokuta
Sacred Heart Hospital
Dedeke, Olabisi Florence
Nigeria, Abeokuta
Sacred Heart Hospital
Akinkunmi, Francis Bola
Nigeria, Ondo
Mother and Child Hospital
Oyeneyin, Lawal O.
Nigeria, Ondo
Mother and Child Hospital
Adesiyun, Omotayo Olukemi
Nigeria, Ilorin
University of Ilorin
Raji, Hadijat Olaide
Nigeria, Ilorin
University of Ilorin
Ande, Adedapo Babatunde Anibaba
Nigeria, Benin
University of Benin
Okonkwo, Ikechukwu Richard
Nigeria, Benin
University of Benin
Ariff, Shabina
Pakistan, Karachi
The Aga Khan University
Soofi, Sajid Bashir
Pakistan, Karachi
The Aga Khan University
Sheikh, Lumaan
Pakistan, Karachi
The Aga Khan University
Sikandar, Raheel
Unknown Affiliation
Giordano, Daniel
Argentina, Rosario
Centro Rosarino de Estudios Perinatales
Gamerro, Hugo
Argentina, Rosario
Centro Rosarino de Estudios Perinatales
Carroli, Guillermo
Argentina, Rosario
Centro Rosarino de Estudios Perinatales
Carvalho, José Ferreira De
Brazil, Campinas
Statistika Consultoria
Neilson, James
United Kingdom, Liverpool
University of Liverpool
Molyneux, Elizabeth M.
Malawi, Blantyre
Kamuzu University of Health Sciences
Yunis, Khalid A.
Lebanon, Beirut
American University of Beirut
Mugerwa, Kidza Yvonne
Uganda, Kampala
Makerere University
Chellani, Harish Kumar
Unknown Affiliation
Statistics
Citations: 74
Authors: 118
Affiliations: 40
Identifiers
Doi:
10.1056/NEJMoa2022398
ISSN:
00284793
Research Areas
Maternal And Child Health
Study Design
Randomised Control Trial
Cohort Study
Study Locations
Kenya
Nigeria
Participants Gender
Female