Article Text

Download PDFPDF

Antenatal corticosteroids for women at risk of imminent preterm birth in low-resource countries: the case for equipoise and the need for efficacy trials
  1. Joshua P Vogel1,
  2. Olufemi T Oladapo1,
  3. Cynthia Pileggi-Castro2,
  4. Ebunoluwa A Adejuyigbe3,
  5. Fernando Althabe4,
  6. Shabina Ariff5,
  7. Adejumoke Idowu Ayede6,
  8. Abdullah H Baqui7,
  9. Anthony Costello2,
  10. Davy M Chikamata8,
  11. Caroline Crowther9,
  12. Bukola Fawole10,
  13. Luz Gibbons4,
  14. Alan H Jobe11,
  15. Monica Lulu Kapasa12,
  16. John Kinuthia13,
  17. Alka Kriplani14,
  18. Oluwafemi Kuti15,
  19. James Neilson16,
  20. Janna Patterson17,
  21. Gilda Piaggio18,
  22. Rahat Qureshi19,
  23. Zahida Qureshi20,
  24. Mari Jeeva Sankar21,
  25. Jeffrey S A Stringer22,
  26. Marleen Temmerman1,
  27. Khalid Yunis23,
  28. Rajiv Bahl2,
  29. A Metin Gülmezoglu1
  1. 1UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland
  2. 2Department of Maternal Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland
  3. 3Department of Paediatrics and Child Health, Obafemi Awolowo University, Ife, Nigeria
  4. 4Department of Mother and Child Health Research for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina
  5. 5Department of Pediatrics & Child Health, Aga Khan University, Karachi, Pakistan
  6. 6Department of Paediatrics, College of Medicine, University of Ibadan, Ibadan, Nigeria
  7. 7International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
  8. 8Ministry of Community Development, Mother & Child Health, Lusaka, Zambia
  9. 9Liggins Institute, The University of Auckland, Auckland, New Zealand
  10. 10Department of Obstetrics & Gynaecology, College of Medicine, University of Ibadan, Ibadan, Nigeria
  11. 11Department of Pediatrics, Cincinnati Childrens Hospital, Cincinnati, Ohio, USA
  12. 12Department of Paediatrics, University Teaching Hospital, Lusaka, Zambia
  13. 13Department of Research & Programs, Kenyatta National Hospital, Nairobi, Kenya
  14. 14All India Institute of Medical Sciences, New Delhi, India
  15. 15Department of Obstetrics, Gynaecology and Perinatology, College of Health Sciences, Obafemi Awolowo University, Ife, Nigeria
  16. 16Department of Women's and Children's Health, The University of Liverpool, Liverpool, UK
  17. 17Maternal, Newborn, and Child Health, Bill and Melinda Gates Foundation, Geneva, Switzerland
  18. 18Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK
  19. 19Department of Obstetrics and Gynecology, Aga Khan University, Karachi, Pakistan
  20. 20Department of Obstetrics and Gynaecology, School of Medicine, University of Nairobi, Nairobi, Kenya
  21. 21Department of Pediatrics, WHO Collaborating Centre for Training and Research in Newborn Care, All India Institute of Medical Sciences (AIIMS), New Delhi, India
  22. 22University of North Carolina, School of Medicine, Chapel Hill, North Carolina, USA
  23. 23National Collaborative Perinatal Neonatal Network, American University of Beirut, Beirut, Lebanon
  1. Correspondence to Joshua P Vogel; vogeljo{at}who.int

Abstract

The scientific basis for antenatal corticosteroids (ACS) for women at risk of preterm birth has rapidly changed in recent years. Two landmark trials—the Antenatal Corticosteroid Trial and the Antenatal Late Preterm Steroids Trial—have challenged the long-held assumptions on the comparative health benefits and harms regarding the use of ACS for preterm birth across all levels of care and contexts, including resource-limited settings. Researchers, clinicians, programme managers, policymakers and donors working in low-income and middle-income countries now face challenging questions of whether, where and how ACS can be used to optimise outcomes for both women and preterm newborns.

In this article, we briefly present an appraisal of the current evidence around ACS, how these findings informed WHO’s current recommendations on ACS use, and the knowledge gaps that have emerged in the light of new trial evidence. Critical considerations in the generalisability of the available evidence demonstrate that a true state of clinical equipoise exists for this treatment option in low-resource settings. An expert group convened by WHO concluded that there is a clear need for more efficacy trials of ACS in these settings to inform clinical practice.

  • preterm birth
  • antenatal corticosteroids
  • neonatal mortality

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

View Full Text

Statistics from Altmetric.com

Footnotes

  • Handling editor Seye Abimbola

  • Contributors The named authors were participants in the WHO technical consultation on a multicountry randomised trial of antenatal corticosteroids for women in at risk of imminent preterm birth to improve newborn outcomes, held in Geneva, Switzerland on 12–13 November 2015. The outline and contents of this article were discussed at the consultation. The article was initially drafted by JPV, OTO, CPC, AMG and RB. All named authors provided comments and agreed on the final version of this article. This article represents the views of the named authors only, and does not represent the views of their organisations.

  • Funding The consultation and the WHO ACTION Trials are supported by a grant from the Bill and Melinda Gates Foundation (grant number OPP1136821). JP is an employee of the Foundation, and provided technical input into the manuscript, which was reviewed by all named authors. The funders had no role in decision to publish. JPV, OTO, CPC, AC, RB and AMG are currently employees of the WHO. At the time of the consultation, MT was an employee of WHO; however, she is currently employed by the Aga Khan Development Network.

  • Competing interests CC is currently chief investigator on a randomised controlled trial to evaluate the role of maternal intramuscular dexamethasone versus betamethasone prior to preterm birth (A*STEROID Trial). AHJ has consulted for possible therapies for respiratory distress syndrome and bronchopulmonary dysplasia with Chiesi; has received respiratory supplies from Fisher & Paykel and surfactant from Chiesi for animal model research; and has received grant support from the National Institute of Child Health and Development, the National Heart, Lung and Blood Institute, Burroughs Welcome, Glaxo Smith Kline and the Bill and Melinda Gates Foundation for studies with premature animal models. FA is a recipient of a research grant from the Bill and Melinda Gates Foundation. The authors otherwise report they have no competing interests to declare.

  • Ethics approval WHO Ethics Review Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The data quoted in this paper are already available in the public domain.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.