The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries

Rajiv Bahl; A. Metin Gülmezoglu; My Huong Nguyen; Olufemi T. Oladapo; Gilda Piaggio; Joshua P. Vogel; Abdullah H. Baqui; Mohammod Shahidullah; Shivaprasad S. Goudar; Ashalata A. Mallapur; Shailaja Bidri; Sujata Misra; John Kinuthia; Zahida Qureshi; Frederick Were; Adejumoke Idowu Ayede; Bukola Fawole; Ebunoluwa A. Adejuyigbe; Oluwafemi Kuti; Shabina Ariff; Lumaan Sheikh; Sajid Soofi; James Neilson; Fernando Althabe; Harish Chellani; Elizabeth Molyneux; Kidza Mugerwa; Khalid Yunis; Liana Campodonico; Guillermo Carroli; Hugo Gamerro; Daniel Giordano; Janna Patterson; Rasheda Khanam; Meagan Harrison; Saleha Begum Chowdhury; Mohammad Abdul Mannan; Begum Nasrin; Salahuddin Ahmed; Nazma Begum; Saima Sultana; Soofia Khatoon; Anjuman Ara; Murshed Ahmed Chowdhury; Probhat Ranjan Dey; Dilip Kumar Bhowmik; Md Abdus Sabur; Mohammad Tarek Azad; Gulshan Ara; Shaheen Akter; Sumia Bari; Md Mojibur Rahman; Farida Yasmin; M. A. Matin; Shahana Ferdous Choudhury; Sangappa M. Dhaded; Mrityunjay C. Metgud; Yeshita V. Pujar; Manjunath S. Somannavar; Sunil S. Vernekar; Veena Herekar; Vishwanath L. Machakanur; Shruti S. Andola; Geetanjali M. Katageri; Sumangala Math; Bhuvaneshwari C. Yelamali; Ramesh Pol; Umesh Ramdurg; Shailaja R. Bidri; Sangamesh Mathpati; Preeti Patil; Bhavana B. Lakhkar; M. M. Patil; Muttu R. Gudadinni; Sujata S. Misra; Maya Padhi; Leena B. Das; Lucy Das; Saumya S. Nanda; Madhusmita J. Pradhan; Girija Shankar G. Mohanty; Rasmita S. Nayak; Bipsha S. Singh; Fredrick Were; Alfred Osoti; George Gwako; Ahmed Laving; Hafsa Mohamed; Faiza Nassir; Nayarit Mohamed; Adelaide Barassa; Joachim Ogindo; Bernard Gwer; Waweru Salome; Grace Ochieng; Njoroge John Githua; Bernadine Lusweti; Michael Abiola Okunlola; Olubukola A. Adesina; Adegoke Gbadegesin Falade; Oluwakemi Funmilola Ashubu; Olubunmi Busari; Wilfred Sanni; Aloysius Ebedi; Ejinkeonye I. Kate; Odiah Violet; Hadiza Abdulaziz Idris; Fatima Ali Sallau; Okoli Chinyere Viola; Ekwem Lilian Osaretin; Theresa Azonima Irinyenikan; Omolayo Adebukola Olubosede; Olufemi M. Omololu; Olugbenga Runsewe; Zainab Imam; Adesina Lawrence Akintan; Olorunfemi Oludele Owa; Olabanke Rosena Oluwafemi; Ireti Patricia Eniowo; Adetokunbo Fabamwo; Elizabeth Disu; Ibraheem Olayemi Awowole; Adebanjo Babalola Adeyemi; Akintunde Olusegun Fehintola; Ebunoluwa Aderonke Adejuyigbe; Henry Chineme Anyabolu; Bankole Peter Kuti; Olusola Comfort Famurewa; Adedapo Babatunde Anibaba Ande; Ikechukwu Okonkwo; Aboyeji Abiodun Peter; Mokuolu Olugbenga; Omotayo Adesiyun; Anthony Dennis Isah; Olateju Eyinade Kudirat; Olusanya Abiodun; Olabisi Florence Dedeke; Lawal Oyeneyin; Francis Bola Akinkunmi; Sajid Bashir Soofi; Nida Najimi; Mubarak Ali; Jamal Anwar; Saima Zulfiqar; Sadia Zulfiqar; Raheel Sikander; Shazia Rani; Salma Sheikh; Shazia Memon

doi:10.1186/s13063-019-3488-z

The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries

Rajiv Bahl, A. Metin Gülmezoglu, My Huong Nguyen, Olufemi T. Oladapo, Gilda Piaggio, Joshua P. Vogel, Abdullah H. Baqui, Mohammod Shahidullah, Shivaprasad S. Goudar, Ashalata A. Mallapur, Shailaja Bidri, Sujata Misra, John Kinuthia, Zahida Qureshi, Frederick Were, Adejumoke Idowu Ayede, Bukola Fawole, Ebunoluwa A. Adejuyigbe, Oluwafemi Kuti, Shabina AriffLumaan Sheikh, Sajid Soofi, James Neilson, Fernando Althabe, Harish Chellani, Elizabeth Molyneux, Kidza Mugerwa, Khalid Yunis, Liana Campodonico, Guillermo Carroli, Hugo Gamerro, Daniel Giordano, Janna Patterson, Rasheda Khanam, Meagan Harrison, Saleha Begum Chowdhury, Mohammad Abdul Mannan, Begum Nasrin, Salahuddin Ahmed, Nazma Begum, Saima Sultana, Soofia Khatoon, Anjuman Ara, Murshed Ahmed Chowdhury, Probhat Ranjan Dey, Dilip Kumar Bhowmik, Md Abdus Sabur, Mohammad Tarek Azad, Gulshan Ara, Shaheen Akter, Sumia Bari, Md Mojibur Rahman, Farida Yasmin, M. A. Matin, Shahana Ferdous Choudhury, Sangappa M. Dhaded, Mrityunjay C. Metgud, Yeshita V. Pujar, Manjunath S. Somannavar, Sunil S. Vernekar, Veena Herekar, Vishwanath L. Machakanur, Shruti S. Andola, Geetanjali M. Katageri, Sumangala Math, Bhuvaneshwari C. Yelamali, Ramesh Pol, Umesh Ramdurg, Shailaja R. Bidri, Sangamesh Mathpati, Preeti Patil, Bhavana B. Lakhkar, M. M. Patil, Muttu R. Gudadinni, Sujata S. Misra, Maya Padhi, Leena B. Das, Lucy Das, Saumya S. Nanda, Madhusmita J. Pradhan, Girija Shankar G. Mohanty, Rasmita S. Nayak, Bipsha S. Singh, Fredrick Were, Alfred Osoti, George Gwako, Ahmed Laving, Hafsa Mohamed, Faiza Nassir, Nayarit Mohamed, Adelaide Barassa, Joachim Ogindo, Bernard Gwer, Waweru Salome, Grace Ochieng, Njoroge John Githua, Bernadine Lusweti, Michael Abiola Okunlola, Olubukola A. Adesina, Adegoke Gbadegesin Falade, Oluwakemi Funmilola Ashubu, Olubunmi Busari, Wilfred Sanni, Aloysius Ebedi, Ejinkeonye I. Kate, Odiah Violet, Hadiza Abdulaziz Idris, Fatima Ali Sallau, Okoli Chinyere Viola, Ekwem Lilian Osaretin, Theresa Azonima Irinyenikan, Omolayo Adebukola Olubosede, Olufemi M. Omololu, Olugbenga Runsewe, Zainab Imam, Adesina Lawrence Akintan, Olorunfemi Oludele Owa, Olabanke Rosena Oluwafemi, Ireti Patricia Eniowo, Adetokunbo Fabamwo, Elizabeth Disu, Ibraheem Olayemi Awowole, Adebanjo Babalola Adeyemi, Akintunde Olusegun Fehintola, Ebunoluwa Aderonke Adejuyigbe, Henry Chineme Anyabolu, Bankole Peter Kuti, Olusola Comfort Famurewa, Adedapo Babatunde Anibaba Ande, Ikechukwu Okonkwo, Aboyeji Abiodun Peter, Mokuolu Olugbenga, Omotayo Adesiyun, Anthony Dennis Isah, Olateju Eyinade Kudirat, Olusanya Abiodun, Olabisi Florence Dedeke, Lawal Oyeneyin, Francis Bola Akinkunmi, Sajid Bashir Soofi, Nida Najimi, Mubarak Ali, Jamal Anwar, Saima Zulfiqar, Sadia Zulfiqar, Raheel Sikander, Shazia Rani, Salma Sheikh, Shazia Memon

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

Background: Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. Methods/design: The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up). Discussion: Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization's global recommendations on ACS use. Trial registration: ACTRN12617000476336. Registered on 31 March 2017.

Original language	English
Article number	507
Journal	Trials
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s13063-019-3488-z
Publication status	Published - 16 Aug 2019
Externally published	Yes

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Bahl, R., Gülmezoglu, A. M., Nguyen, M. H., Oladapo, O. T., Piaggio, G., Vogel, J. P., Baqui, A. H., Shahidullah, M., Goudar, S. S., Mallapur, A. A., Bidri, S., Misra, S., Kinuthia, J., Qureshi, Z., Were, F., Ayede, A. I., Fawole, B., Adejuyigbe, E. A., Kuti, O., ... Memon, S. (2019). The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries. Trials, 20(1), Article 507. https://doi.org/10.1186/s13063-019-3488-z

Bahl, Rajiv ; Gülmezoglu, A. Metin ; Nguyen, My Huong et al. / The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial : A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries. In: Trials. 2019 ; Vol. 20, No. 1.

@article{2d45eff125524dd69f86d4ab5563641a,

title = "The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries",

abstract = "Background: Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. Methods/design: The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up). Discussion: Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization's global recommendations on ACS use. Trial registration: ACTRN12617000476336. Registered on 31 March 2017.",

author = "Rajiv Bahl and G{\"u}lmezoglu, {A. Metin} and Nguyen, {My Huong} and Oladapo, {Olufemi T.} and Gilda Piaggio and Vogel, {Joshua P.} and Baqui, {Abdullah H.} and Mohammod Shahidullah and Goudar, {Shivaprasad S.} and Mallapur, {Ashalata A.} and Shailaja Bidri and Sujata Misra and John Kinuthia and Zahida Qureshi and Frederick Were and Ayede, {Adejumoke Idowu} and Bukola Fawole and Adejuyigbe, {Ebunoluwa A.} and Oluwafemi Kuti and Shabina Ariff and Lumaan Sheikh and Sajid Soofi and James Neilson and Fernando Althabe and Harish Chellani and Elizabeth Molyneux and Kidza Mugerwa and Khalid Yunis and Liana Campodonico and Guillermo Carroli and Hugo Gamerro and Daniel Giordano and Janna Patterson and Rasheda Khanam and Meagan Harrison and Chowdhury, {Saleha Begum} and Mannan, {Mohammad Abdul} and Begum Nasrin and Salahuddin Ahmed and Nazma Begum and Saima Sultana and Soofia Khatoon and Anjuman Ara and Chowdhury, {Murshed Ahmed} and Dey, {Probhat Ranjan} and Bhowmik, {Dilip Kumar} and Sabur, {Md Abdus} and Azad, {Mohammad Tarek} and Gulshan Ara and Shaheen Akter and Sumia Bari and Rahman, {Md Mojibur} and Farida Yasmin and Matin, {M. A.} and Choudhury, {Shahana Ferdous} and Dhaded, {Sangappa M.} and Metgud, {Mrityunjay C.} and Pujar, {Yeshita V.} and Somannavar, {Manjunath S.} and Vernekar, {Sunil S.} and Veena Herekar and Machakanur, {Vishwanath L.} and Andola, {Shruti S.} and Katageri, {Geetanjali M.} and Sumangala Math and Yelamali, {Bhuvaneshwari C.} and Ramesh Pol and Umesh Ramdurg and Bidri, {Shailaja R.} and Sangamesh Mathpati and Preeti Patil and Lakhkar, {Bhavana B.} and Patil, {M. M.} and Gudadinni, {Muttu R.} and Misra, {Sujata S.} and Maya Padhi and Das, {Leena B.} and Lucy Das and Nanda, {Saumya S.} and Pradhan, {Madhusmita J.} and Mohanty, {Girija Shankar G.} and Nayak, {Rasmita S.} and Singh, {Bipsha S.} and Fredrick Were and Alfred Osoti and George Gwako and Ahmed Laving and Hafsa Mohamed and Faiza Nassir and Nayarit Mohamed and Adelaide Barassa and Joachim Ogindo and Bernard Gwer and Waweru Salome and Grace Ochieng and Githua, {Njoroge John} and Bernadine Lusweti and Okunlola, {Michael Abiola} and Adesina, {Olubukola A.} and Falade, {Adegoke Gbadegesin} and Ashubu, {Oluwakemi Funmilola} and Olubunmi Busari and Wilfred Sanni and Aloysius Ebedi and Kate, {Ejinkeonye I.} and Odiah Violet and Idris, {Hadiza Abdulaziz} and Sallau, {Fatima Ali} and Viola, {Okoli Chinyere} and Osaretin, {Ekwem Lilian} and Irinyenikan, {Theresa Azonima} and Olubosede, {Omolayo Adebukola} and Omololu, {Olufemi M.} and Olugbenga Runsewe and Zainab Imam and Akintan, {Adesina Lawrence} and Owa, {Olorunfemi Oludele} and Oluwafemi, {Olabanke Rosena} and Eniowo, {Ireti Patricia} and Adetokunbo Fabamwo and Elizabeth Disu and Awowole, {Ibraheem Olayemi} and Adeyemi, {Adebanjo Babalola} and Fehintola, {Akintunde Olusegun} and Adejuyigbe, {Ebunoluwa Aderonke} and Anyabolu, {Henry Chineme} and Kuti, {Bankole Peter} and Famurewa, {Olusola Comfort} and Ande, {Adedapo Babatunde Anibaba} and Ikechukwu Okonkwo and Peter, {Aboyeji Abiodun} and Mokuolu Olugbenga and Omotayo Adesiyun and Isah, {Anthony Dennis} and Kudirat, {Olateju Eyinade} and Olusanya Abiodun and Dedeke, {Olabisi Florence} and Lawal Oyeneyin and Akinkunmi, {Francis Bola} and Soofi, {Sajid Bashir} and Nida Najimi and Mubarak Ali and Jamal Anwar and Saima Zulfiqar and Sadia Zulfiqar and Raheel Sikander and Shazia Rani and Salma Sheikh and Shazia Memon",

note = "Funding Information: This trial is supported by the Bill and Melinda Gates Foundation, and the Departments of Reproductive Health and Research, and Maternal, Newborn, Child and Adolescent Health at WHO. Publisher Copyright: {\textcopyright} 2019 The Author(s).",

year = "2019",

month = aug,

day = "16",

doi = "10.1186/s13063-019-3488-z",

language = "English",

volume = "20",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

number = "1",

}

Bahl, R, Gülmezoglu, AM, Nguyen, MH, Oladapo, OT, Piaggio, G, Vogel, JP, Baqui, AH, Shahidullah, M, Goudar, SS, Mallapur, AA, Bidri, S, Misra, S, Kinuthia, J, Qureshi, Z, Were, F, Ayede, AI, Fawole, B, Adejuyigbe, EA, Kuti, O, Ariff, S , Sheikh, L, Soofi, S, Neilson, J, Althabe, F, Chellani, H, Molyneux, E, Mugerwa, K, Yunis, K, Campodonico, L, Carroli, G, Gamerro, H, Giordano, D, Patterson, J, Khanam, R, Harrison, M, Chowdhury, SB, Mannan, MA, Nasrin, B, Ahmed, S, Begum, N, Sultana, S, Khatoon, S, Ara, A, Chowdhury, MA, Dey, PR, Bhowmik, DK, Sabur, MA, Azad, MT, Ara, G, Akter, S, Bari, S, Rahman, MM, Yasmin, F, Matin, MA, Choudhury, SF, Dhaded, SM, Metgud, MC, Pujar, YV, Somannavar, MS, Vernekar, SS, Herekar, V, Machakanur, VL, Andola, SS, Katageri, GM, Math, S, Yelamali, BC, Pol, R, Ramdurg, U, Bidri, SR, Mathpati, S, Patil, P, Lakhkar, BB, Patil, MM, Gudadinni, MR, Misra, SS, Padhi, M, Das, LB, Das, L, Nanda, SS, Pradhan, MJ, Mohanty, GSG, Nayak, RS, Singh, BS, Were, F, Osoti, A, Gwako, G, Laving, A, Mohamed, H, Nassir, F, Mohamed, N, Barassa, A, Ogindo, J, Gwer, B, Salome, W, Ochieng, G, Githua, NJ, Lusweti, B, Okunlola, MA, Adesina, OA, Falade, AG, Ashubu, OF, Busari, O, Sanni, W, Ebedi, A, Kate, EI, Violet, O, Idris, HA, Sallau, FA, Viola, OC, Osaretin, EL, Irinyenikan, TA, Olubosede, OA, Omololu, OM, Runsewe, O, Imam, Z, Akintan, AL, Owa, OO, Oluwafemi, OR, Eniowo, IP, Fabamwo, A, Disu, E, Awowole, IO, Adeyemi, AB, Fehintola, AO, Adejuyigbe, EA, Anyabolu, HC, Kuti, BP, Famurewa, OC, Ande, ABA, Okonkwo, I, Peter, AA, Olugbenga, M, Adesiyun, O, Isah, AD, Kudirat, OE, Abiodun, O, Dedeke, OF, Oyeneyin, L, Akinkunmi, FB, Soofi, SB, Najimi, N, Ali, M, Anwar, J, Zulfiqar, S, Zulfiqar, S, Sikander, R, Rani, S, Sheikh, S & Memon, S 2019, 'The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries', Trials, vol. 20, no. 1, 507. https://doi.org/10.1186/s13063-019-3488-z

The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries. / Bahl, Rajiv; Gülmezoglu, A. Metin; Nguyen, My Huong et al.
In: Trials, Vol. 20, No. 1, 507, 16.08.2019.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial

T2 - A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries

AU - Bahl, Rajiv

AU - Gülmezoglu, A. Metin

AU - Nguyen, My Huong

AU - Oladapo, Olufemi T.

AU - Piaggio, Gilda

AU - Vogel, Joshua P.

AU - Baqui, Abdullah H.

AU - Shahidullah, Mohammod

AU - Goudar, Shivaprasad S.

AU - Mallapur, Ashalata A.

AU - Bidri, Shailaja

AU - Misra, Sujata

AU - Kinuthia, John

AU - Qureshi, Zahida

AU - Were, Frederick

AU - Ayede, Adejumoke Idowu

AU - Fawole, Bukola

AU - Adejuyigbe, Ebunoluwa A.

AU - Kuti, Oluwafemi

AU - Ariff, Shabina

AU - Sheikh, Lumaan

AU - Soofi, Sajid

AU - Neilson, James

AU - Althabe, Fernando

AU - Chellani, Harish

AU - Molyneux, Elizabeth

AU - Mugerwa, Kidza

AU - Yunis, Khalid

AU - Campodonico, Liana

AU - Carroli, Guillermo

AU - Gamerro, Hugo

AU - Giordano, Daniel

AU - Patterson, Janna

AU - Khanam, Rasheda

AU - Harrison, Meagan

AU - Chowdhury, Saleha Begum

AU - Mannan, Mohammad Abdul

AU - Nasrin, Begum

AU - Ahmed, Salahuddin

AU - Begum, Nazma

AU - Sultana, Saima

AU - Khatoon, Soofia

AU - Ara, Anjuman

AU - Chowdhury, Murshed Ahmed

AU - Dey, Probhat Ranjan

AU - Bhowmik, Dilip Kumar

AU - Sabur, Md Abdus

AU - Azad, Mohammad Tarek

AU - Ara, Gulshan

AU - Akter, Shaheen

AU - Bari, Sumia

AU - Rahman, Md Mojibur

AU - Yasmin, Farida

AU - Matin, M. A.

AU - Choudhury, Shahana Ferdous

AU - Dhaded, Sangappa M.

AU - Metgud, Mrityunjay C.

AU - Pujar, Yeshita V.

AU - Somannavar, Manjunath S.

AU - Vernekar, Sunil S.

AU - Herekar, Veena

AU - Machakanur, Vishwanath L.

AU - Andola, Shruti S.

AU - Katageri, Geetanjali M.

AU - Math, Sumangala

AU - Yelamali, Bhuvaneshwari C.

AU - Pol, Ramesh

AU - Ramdurg, Umesh

AU - Bidri, Shailaja R.

AU - Mathpati, Sangamesh

AU - Patil, Preeti

AU - Lakhkar, Bhavana B.

AU - Patil, M. M.

AU - Gudadinni, Muttu R.

AU - Misra, Sujata S.

AU - Padhi, Maya

AU - Das, Leena B.

AU - Das, Lucy

AU - Nanda, Saumya S.

AU - Pradhan, Madhusmita J.

AU - Mohanty, Girija Shankar G.

AU - Nayak, Rasmita S.

AU - Singh, Bipsha S.

AU - Were, Fredrick

AU - Osoti, Alfred

AU - Gwako, George

AU - Laving, Ahmed

AU - Mohamed, Hafsa

AU - Nassir, Faiza

AU - Mohamed, Nayarit

AU - Barassa, Adelaide

AU - Ogindo, Joachim

AU - Gwer, Bernard

AU - Salome, Waweru

AU - Ochieng, Grace

AU - Githua, Njoroge John

AU - Lusweti, Bernadine

AU - Okunlola, Michael Abiola

AU - Adesina, Olubukola A.

AU - Falade, Adegoke Gbadegesin

AU - Ashubu, Oluwakemi Funmilola

AU - Busari, Olubunmi

AU - Sanni, Wilfred

AU - Ebedi, Aloysius

AU - Kate, Ejinkeonye I.

AU - Violet, Odiah

AU - Idris, Hadiza Abdulaziz

AU - Sallau, Fatima Ali

AU - Viola, Okoli Chinyere

AU - Osaretin, Ekwem Lilian

AU - Irinyenikan, Theresa Azonima

AU - Olubosede, Omolayo Adebukola

AU - Omololu, Olufemi M.

AU - Runsewe, Olugbenga

AU - Imam, Zainab

AU - Akintan, Adesina Lawrence

AU - Owa, Olorunfemi Oludele

AU - Oluwafemi, Olabanke Rosena

AU - Eniowo, Ireti Patricia

AU - Fabamwo, Adetokunbo

AU - Disu, Elizabeth

AU - Awowole, Ibraheem Olayemi

AU - Adeyemi, Adebanjo Babalola

AU - Fehintola, Akintunde Olusegun

AU - Adejuyigbe, Ebunoluwa Aderonke

AU - Anyabolu, Henry Chineme

AU - Kuti, Bankole Peter

AU - Famurewa, Olusola Comfort

AU - Ande, Adedapo Babatunde Anibaba

AU - Okonkwo, Ikechukwu

AU - Peter, Aboyeji Abiodun

AU - Olugbenga, Mokuolu

AU - Adesiyun, Omotayo

AU - Isah, Anthony Dennis

AU - Kudirat, Olateju Eyinade

AU - Abiodun, Olusanya

AU - Dedeke, Olabisi Florence

AU - Oyeneyin, Lawal

AU - Akinkunmi, Francis Bola

AU - Soofi, Sajid Bashir

AU - Najimi, Nida

AU - Ali, Mubarak

AU - Anwar, Jamal

AU - Zulfiqar, Saima

AU - Zulfiqar, Sadia

AU - Sikander, Raheel

AU - Rani, Shazia

AU - Sheikh, Salma

AU - Memon, Shazia

N1 - Funding Information: This trial is supported by the Bill and Melinda Gates Foundation, and the Departments of Reproductive Health and Research, and Maternal, Newborn, Child and Adolescent Health at WHO. Publisher Copyright: © 2019 The Author(s).

PY - 2019/8/16

Y1 - 2019/8/16

N2 - Background: Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. Methods/design: The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up). Discussion: Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization's global recommendations on ACS use. Trial registration: ACTRN12617000476336. Registered on 31 March 2017.

AB - Background: Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries. Methods/design: The trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up). Discussion: Findings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization's global recommendations on ACS use. Trial registration: ACTRN12617000476336. Registered on 31 March 2017.

UR - http://www.scopus.com/inward/record.url?scp=85071024806&partnerID=8YFLogxK

U2 - 10.1186/s13063-019-3488-z

DO - 10.1186/s13063-019-3488-z

M3 - Article

C2 - 31420064

AN - SCOPUS:85071024806

SN - 1745-6215

VL - 20

JO - Trials

JF - Trials

IS - 1

M1 - 507

ER -

Bahl R, Gülmezoglu AM, Nguyen MH, Oladapo OT, Piaggio G, Vogel JP et al. The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries. Trials. 2019 Aug 16;20(1):507. doi: 10.1186/s13063-019-3488-z

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