Randomized Controlled Trial

. 2020 Dec 24;383(26):2514-2525.

doi: 10.1056/NEJMoa2022398. Epub 2020 Oct 23.

Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries

WHO ACTION Trials Collaborators; Olufemi T Oladapo¹, Joshua P Vogel¹, Gilda Piaggio¹, My-Huong Nguyen¹, Fernando Althabe¹, A Metin Gülmezoglu¹, Rajiv Bahl¹, Suman P N Rao¹, Ayesha De Costa¹, Shuchita Gupta¹, Abdullah H Baqui¹, Rasheda Khanam¹, Mohammod Shahidullah¹, Saleha B Chowdhury¹, Salahuddin Ahmed¹, Nazma Begum¹, Arunangshu D Roy¹, M A Shahed¹, Iffat A Jaben¹, Farida Yasmin¹, M Mozibur Rahman¹, Anjuman Ara¹, Soofia Khatoon¹, Gulshan Ara¹, Shaheen Akter¹, Nasreen Akhter¹, Probhat R Dey¹, M Abdus Sabur¹, Mohammad T Azad¹, Shahana F Choudhury¹, M A Matin¹, Shivaprasad S Goudar¹, Sangappa M Dhaded¹, Mrityunjay C Metgud¹, Yeshita V Pujar¹, Manjunath S Somannavar¹, Sunil S Vernekar¹, Veena R Herekar¹, Shailaja R Bidri¹, Sangamesh S Mathapati¹, Preeti G Patil¹, Mallanagouda M Patil¹, Muttappa R Gudadinni¹, Hidaytullah R Bijapure¹, Ashalata A Mallapur¹, Geetanjali M Katageri¹, Sumangala B Chikkamath¹, Bhuvaneshwari C Yelamali¹, Ramesh R Pol¹, Sujata S Misra¹, Leena Das¹, Saumya Nanda¹, Rashmita B Nayak¹, Bipsa Singh¹, Zahida Qureshi¹, Fredrick Were¹, Alfred Osoti¹, George Gwako¹, Ahmed Laving¹, John Kinuthia¹, Hafsa Mohamed¹, Nawal Aliyan¹, Adelaide Barassa¹, Elizabeth Kibaru¹, Margaret Mbuga¹, Lydia Thuranira¹, Njoroge J Githua¹, Bernadine Lusweti¹, Adejumoke I Ayede¹, Adegoke G Falade¹, Olubukola A Adesina¹, Atinuke M Agunloye¹, Oluwatosin O Iyiola¹, Wilfred Sanni¹, Ifeyinwa K Ejinkeonye¹, Hadiza A Idris¹, Chinyere V Okoli¹, Theresa A Irinyenikan¹, Omolayo A Olubosede¹, Olaseinde Bello¹, Olufemi M Omololu¹, Olanike A Olutekunbi¹, Adesina L Akintan¹, Olorunfemi O Owa¹, Rosena O Oluwafemi¹, Ireti P Eniowo¹, Adetokunbo O Fabamwo¹, Elizabeth A Disu¹, Joy O Agbara¹, Ebunoluwa A Adejuyigbe¹, Oluwafemi Kuti¹, Henry C Anyabolu¹, Ibraheem O Awowole¹, Akintunde O Fehintola¹, Bankole P Kuti¹, Anthony D Isah¹, Eyinade K Olateju¹, Olusanya Abiodun¹, Olabisi F Dedeke¹, Francis B Akinkunmi¹, Lawal Oyeneyin¹, Omotayo Adesiyun¹, Hadijat O Raji¹, Adedapo B A Ande¹, Ikechukwu Okonkwo¹, Shabina Ariff¹, Sajid B Soofi¹, Lumaan Sheikh¹, Saima Zulfiqar¹, Sadia Omer¹, Raheel Sikandar¹, Salma Sheikh¹, Daniel Giordano¹, Hugo Gamerro¹, Guillermo Carroli¹, Jose Carvalho¹, James Neilson¹, Elizabeth Molyneux¹, Khalid Yunis¹, Kidza Mugerwa¹, Harish K Chellani¹

Collaborators, Affiliations

Collaborators

WHO ACTION Trials Collaborators:
Olufemi T Oladapo, Joshua P Vogel, Gilda Piaggio, My Huong Nguyen, Fernando Althabe, A Metin Gülmezoglu, Rajiv Bahl, Suman P N Rao, Ayesha De Costa, Shuchita Gupta, Abdullah H Baqui, Rasheda Khanam, Mohammod Shahidullah, Saleha Begum Chowdhury, Salahuddin Ahmed, Nazma Begum, Arunangshu Dutta Roy, Iffat Ara Jaben, Soofia Khatoon, Anjuman Ara, Probhat Ranjan Dey, Nasreen Akhter, Md Abdus Sabur, Mohammad Tarek Azad, Gulshan Ara, Shaheen Akter, Md Mozibur Rahman, Farida Yasmin, M A Matin, Shahana Ferdous Choudhury, Shivaprasad S Goudar, Sangappa M Dhaded, Mrityunjay C Metgud, Yeshita V Pujar, Manjunath S Somannavar, Sunil S Vernekar, Veena R Herekar, Ashalata A Mallapur, Geetanjali M Katageri, Sumangala B Chikkamath, Bhuvaneshwari C Yelamali, Ramesh R Pol, Shailaja R Bidri, Sangamesh S Mathapati, Preeti G Patil, Mallanagouda M Patil, Muttappa R Gudadinni, Hidaytullah R Bijapure, Sujata S Misra, Leena Das, Saumya Nanda, Rashmita B Nayak, Bipsa Singh, Zahida Qureshi, Fredrick Were, Alfred Osoti, George Gwako, Ahmed Laving, John Kinuthia, Hafsa Mohamed, Nawal Aliyan, Adelaide Barassa, Elizabeth Kibaru, Margaret Mbuga, Lydia Thuranira, Njoroge John Githua, Bernadine Lusweti, Adejumoke Idowu Ayede, Olubukola Adeponle Adesina, Adegoke Gbadegesin Falade, Atinuke Monsurat Agunloye, Oluwatosin Olaniyi Iyiola, Wilfred Sanni, Ifeyinwa Kate Ejinkeonye, Hadiza Abdulaziz Idris, Chinyere Viola Okoli, Theresa Azonima Irinyenikan, Omolayo Adebukola Olubosede, Olaseinde Bello, Olufemi Motunolani Omololu, Olanike Abosede Olutekunbi, Adesina Lawrence Akintan, Olorunfemi Oludele Owa, Rosena Olubanke Oluwafemi, Ireti Patricia Eniowo, Adetokunbo Olusegun Fabamwo, Elizabeth Aruma Disu, Joy Onyinyechi Agbara, Oluwafemi Kuti, Ebunoluwa Aderonke Adejuyigbe, Henry Chineme Anyabolu, Ibraheem Olayemi Awowole, Akintunde Olusegun Fehintola, Bankole Peter Kuti, Adedapo Babatunde Anibaba Ande, Ikechukwu Okonkwo, Omotayo Adesiyun, Hadijat Olaide Raji, Anthony Dennis Isah, Eyinade Kudirat Olateju, Olusanya Abiodun MBChB, Olabisi Florence Dedeke, Lawal Oyeneyin, Francis Bola Akinkunmi, Shabina Ariff, Sajid Bashir Soofi, Lumaan Sheikh, Saima Zulfiqar, Sadia Omer, Raheel Sikandar, Salma Sheikh, Daniel Giordano, Hugo Gamerro, Guillermo Carroli, Jose Carvalho, James Neilson, Elizabeth Molyneux, Khalid Yunis, Kidza Mugerwa, Harish Kumar Chellani

Affiliation

¹ The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).

PMID: 33095526
PMCID: PMC7660991
DOI: 10.1056/NEJMoa2022398

Randomized Controlled Trial

Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries

WHO ACTION Trials Collaborators et al. N Engl J Med. 2020.

. 2020 Dec 24;383(26):2514-2525.

doi: 10.1056/NEJMoa2022398. Epub 2020 Oct 23.

Authors

Collaborators

WHO ACTION Trials Collaborators:
Olufemi T Oladapo, Joshua P Vogel, Gilda Piaggio, My Huong Nguyen, Fernando Althabe, A Metin Gülmezoglu, Rajiv Bahl, Suman P N Rao, Ayesha De Costa, Shuchita Gupta, Abdullah H Baqui, Rasheda Khanam, Mohammod Shahidullah, Saleha Begum Chowdhury, Salahuddin Ahmed, Nazma Begum, Arunangshu Dutta Roy, Iffat Ara Jaben, Soofia Khatoon, Anjuman Ara, Probhat Ranjan Dey, Nasreen Akhter, Md Abdus Sabur, Mohammad Tarek Azad, Gulshan Ara, Shaheen Akter, Md Mozibur Rahman, Farida Yasmin, M A Matin, Shahana Ferdous Choudhury, Shivaprasad S Goudar, Sangappa M Dhaded, Mrityunjay C Metgud, Yeshita V Pujar, Manjunath S Somannavar, Sunil S Vernekar, Veena R Herekar, Ashalata A Mallapur, Geetanjali M Katageri, Sumangala B Chikkamath, Bhuvaneshwari C Yelamali, Ramesh R Pol, Shailaja R Bidri, Sangamesh S Mathapati, Preeti G Patil, Mallanagouda M Patil, Muttappa R Gudadinni, Hidaytullah R Bijapure, Sujata S Misra, Leena Das, Saumya Nanda, Rashmita B Nayak, Bipsa Singh, Zahida Qureshi, Fredrick Were, Alfred Osoti, George Gwako, Ahmed Laving, John Kinuthia, Hafsa Mohamed, Nawal Aliyan, Adelaide Barassa, Elizabeth Kibaru, Margaret Mbuga, Lydia Thuranira, Njoroge John Githua, Bernadine Lusweti, Adejumoke Idowu Ayede, Olubukola Adeponle Adesina, Adegoke Gbadegesin Falade, Atinuke Monsurat Agunloye, Oluwatosin Olaniyi Iyiola, Wilfred Sanni, Ifeyinwa Kate Ejinkeonye, Hadiza Abdulaziz Idris, Chinyere Viola Okoli, Theresa Azonima Irinyenikan, Omolayo Adebukola Olubosede, Olaseinde Bello, Olufemi Motunolani Omololu, Olanike Abosede Olutekunbi, Adesina Lawrence Akintan, Olorunfemi Oludele Owa, Rosena Olubanke Oluwafemi, Ireti Patricia Eniowo, Adetokunbo Olusegun Fabamwo, Elizabeth Aruma Disu, Joy Onyinyechi Agbara, Oluwafemi Kuti, Ebunoluwa Aderonke Adejuyigbe, Henry Chineme Anyabolu, Ibraheem Olayemi Awowole, Akintunde Olusegun Fehintola, Bankole Peter Kuti, Adedapo Babatunde Anibaba Ande, Ikechukwu Okonkwo, Omotayo Adesiyun, Hadijat Olaide Raji, Anthony Dennis Isah, Eyinade Kudirat Olateju, Olusanya Abiodun MBChB, Olabisi Florence Dedeke, Lawal Oyeneyin, Francis Bola Akinkunmi, Shabina Ariff, Sajid Bashir Soofi, Lumaan Sheikh, Saima Zulfiqar, Sadia Omer, Raheel Sikandar, Salma Sheikh, Daniel Giordano, Hugo Gamerro, Guillermo Carroli, Jose Carvalho, James Neilson, Elizabeth Molyneux, Khalid Yunis, Kidza Mugerwa, Harish Kumar Chellani

Affiliation

¹ The affiliations of the members of the writing committee are as follows: World Health Organization, Geneva (O.T.O., J.P.V., G.P., M.-H.N., F.A., A.M.G., R.B., S.P.N.R., A.D.C., S.G.); Johns Hopkins Bloomberg School of Public Health, Baltimore (A.H.B., R.K.); Bangabandhu Sheikh Mujib Medical University (M.S., S.B. Chowdhury), Projahnmo Research Foundation (S. Ahmed, N.B., A.D.R., M.A. Shahed, I.A.J.), Institute of Child and Mother Health (F.Y., M.M.R.), Center for Woman and Child Health (A.A., S.K.), and Enam Medical College and Hospital (G.A., S. Akter), Dhaka, and Sylhet Muhammad Ataul Gani Osmani Medical College Hospital (N. Akhter, P.R.D.), Jalalabad Ragib-Rabeya Medical College Hospital (M.A. Sabur, M.T.A.), and Sylhet Women's Medical College Hospital (S.F.C., M.A.M.), Sylhet - both in Bangladesh; KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi (S.S.G., S.M.D., M.C.M., Y.V.P., M.S.S., S.S.V., V.R.H.), Shri B.M. Patil Medical College, Vijayapura (S.R.B., S.S. Mathapati, P.G.P., M.M.P., M.R.G., H.R.B.), S. Nijalingappa Medical College, Bagalkot (A.A.M., G.M.K., S.B. Chikkamath, B.C.Y., R.R.P.), Srirama Chandra Bhanja Medical College, Cuttack (S.S. Misra, L.D., S.N., R.B.N., B.S.), and Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi (H.K.C.) - all in India; University of Nairobi (Z.Q., F.W., A. Osoti, G.G., A.L.) and Kenyatta National Hospital (J.K.), Nairobi, Coast Provincial General Hospital, Mombasa (H.M., N. Aliyan), Nakuru Level 5 Hospital, Nakuru (A.B., E.K.), Kiambu Level 5 Hospital, Kiambu (M.M., L.T.), and Thika Level 5 Hospital, Thika (N.J.G., B.L.) - all in Kenya; the College of Medicine, University of Ibadan, and University College Hospital, Ibadan (A.I.A., A.G.F., O.A.A., A.M.A., O.O.I.), Kubwa General Hospital, Kubwa (W.S., I.K.E.), Nyanya General Hospital, Nyanya (H.A.I., C.V.O.), State Specialist Hospital (T.A.I., O.A. Olubosede, O.B.) and Mother and Child Hospital (A.L.A., O.O.O., R.O.O., I.P.E.), Akure, Lagos Island Maternity Hospital (O.M.O., O.A. Olutekunbi), and Lagos State University Teaching Hospital (A.O. Fabamwo, E.A.D., J.O.A.), Lagos, Obafemi Awolowo University, Ile-Ife (E.A.A., O.K., H.C.A., I.O.A., A.O. Fehintola, B.P.K.), University of Abuja, Abuja (A.D.I., E.K.O.), Sacred Heart Hospital, Abeokuta (O. Abiodun, O.F.D.), Mother and Child Hospital, Ondo (F.B.A., L.O.), University of Ilorin, Ilorin (O. Adesiyun, H.O.R.), and University of Benin, Benin City (A.B.A.A., I.O.) - all in Nigeria; Aga Khan University, Karachi (S. Ariff, S.B.S., L.S.), Sheikh Zayed Medical College and Hospital, Rahim Yar Khan (S.Z., S.O.), and Liaquat University Hospital, Hyderabad (R.S., S.S.) - all in Pakistan; Centro Rosarino de Estudios Perinatales, Rosario, Argentina (D.G., H.G., G.C.); Statistika Consultoria, Campinas, Brazil (J.C.); University of Liverpool, Liverpool, United Kingdom (J.N.); College of Medicine, University of Malawi, Blantyre (E.M.); American University of Beirut, Beirut, Lebanon (K.Y.); and the Makerere University College of Health Sciences, Kampala, Uganda (K.M.).

PMID: 33095526
PMCID: PMC7660991
DOI: 10.1056/NEJMoa2022398

Abstract

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. (Funded by the Bill and Melinda Gates Foundation and the World Health Organization; Australian and New Zealand Clinical Trials Registry number, ACTRN12617000476336; Clinical Trials Registry-India number, CTRI/2017/04/008326.).

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Figures

**Figure 1**
Screening, enrolment, randomization, and follow-up

**Figure 2**
Neonatal primary outcomes by subgroups

See this image and copyright information in PMC

Comment in

Antenatal Glucocorticoids in Low-Resource Settings - Who, When, and Where?
Rouse DJ, Stringer JSA. Rouse DJ, et al. N Engl J Med. 2020 Dec 24;383(26):2584-2585. doi: 10.1056/NEJMe2032499. N Engl J Med. 2020. PMID: 33369361 No abstract available.
Antenatal dexamethasone reduces risk of neonatal death among women in low-resource countries without an increase in maternal bacterial infection.
Ahmed A, Brunton A. Ahmed A, et al. Arch Dis Child Educ Pract Ed. 2022 Oct;107(5):390. doi: 10.1136/archdischild-2021-321557. Epub 2021 Apr 20. Arch Dis Child Educ Pract Ed. 2022. PMID: 33879523 No abstract available.
Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.
Schmitz T, Sénat MV, Sentilhes L. Schmitz T, et al. N Engl J Med. 2021 Apr 22;384(16):e58. doi: 10.1056/NEJMc2102042. N Engl J Med. 2021. PMID: 33882212 No abstract available.
Antenatal dexamethasone reduces mortality in preterm infants in low-resource countries.
Patil MS, Gandhi BB, Gowda SH. Patil MS, et al. Acta Paediatr. 2022 Mar;111(3):694-695. doi: 10.1111/apa.16145. Epub 2021 Oct 29. Acta Paediatr. 2022. PMID: 34713493 No abstract available.

References

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Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries

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Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries

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