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 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, Shivaprasad S. Goudar, 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 journalArticlepeer-review

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 languageEnglish (US)
Article number507
JournalTrials
Volume20
Issue number1
DOIs
StatePublished - Aug 16 2019
Externally publishedYes

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this