Walking the walk to include pregnant participants in non-obstetric clinical trials: Insights from the SNAP Trial

Isabelle Malhamé^{1

2}, Erica Hardy³, Matthew P Cheng^{1

2}, Steven Yc Tong^{4

5}, Asha C Bowen^{6

7}

Affiliations

¹ Department of Medicine, McGill University Health Centre, Canada.
² Research Institute of the McGill University Health Centre, Canada.
³ Department of Medicine, Women and Infants Hospital, Warren Alpert School of Medicine of Brown University, USA.
⁴ Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Australia.
⁵ Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
⁶ Department of Infectious Diseases, Perth Children's Hospital, Australia.
⁷ Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Australia.

Editorial

Isabelle Malhamé et al. Obstet Med. 2023 Mar.

. 2023 Mar;16(1):3-4.

doi: 10.1177/1753495X231163351. Epub 2023 Mar 22.

Isabelle Malhamé^{1

2}, Erica Hardy³, Matthew P Cheng^{1

2}, Steven Yc Tong^{4

5}, Asha C Bowen^{6

7}

¹ Department of Medicine, McGill University Health Centre, Canada.
² Research Institute of the McGill University Health Centre, Canada.
³ Department of Medicine, Women and Infants Hospital, Warren Alpert School of Medicine of Brown University, USA.
⁴ Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Australia.
⁵ Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
⁶ Department of Infectious Diseases, Perth Children's Hospital, Australia.
⁷ Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Australia.

No abstract available

References

1. Jorgensen SCJ, Miljanic S, Tabbara N, et al. Inclusion of pregnant and breastfeeding women in nonobstetrical randomized controlled trials. Am J Obstet Gynecol MFM 2022; 4: 100700. - PubMed
1. Malhamé I, Souza D, Cheng Ret al. et al. The moral imperative to include pregnant women in clinical trials of interventions for COVID-19. Ann Intern Med 2020; 173: 836–837. - PMC - PubMed
1. Trahan MJ, Cumyn A, Cheng MP, et al. Physician perspectives on including pregnant women in COVID-19 clinical trials: time for a paradigm change. Ethics Hum Res 2021; 43: 19–27. - PMC - PubMed
1. Baylis F, Halperin S. Research involving pregnant women: trials and tribulations. Clin Investig (Lond) 2012; 2: 139–146.
1. van der Zande ISE, van der Graaf R, Browne JLet al. et al. Fair inclusion of pregnant women in clinical research: a systematic review of reported reasons for exclusion. In: Baylis F and Ballantyne A (eds) Clinical research involving pregnant women. Research Ethics Forum, vol 3. Cham: Springer, 2016. 10.1007/978-3-319-26512-4_5. - DOI