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2. 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

Author

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

Subjects
Pediatrics, medicine.medical_specialty, Low resource, Medicine (miscellaneous), Placebo, World Health Organization, World health, Dexamethasone, law.invention, Double blind, Study Protocol, Randomized controlled trial, Double-Blind Method, law, Pregnancy, Medicine, Humans, Pharmacology (medical), Multi centre, lcsh:R5-920, business.industry, Prenatal Care, Action (philosophy), Health Resources, Premature Birth, Female, business, lcsh:Medicine (General), Infant, Premature, Multi country
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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3488-z) contains supplementary material, which is available to authorized users.

Published
2019
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