Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.

Abstract

Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.

• Authors: Melanie M Taylor, Loulou Kobeissi, Caron Kim, Avni Amin, Anna E Thorson, Nita B Bellare, Vanessa Brizuela, Mercedes Bonet, Edna Kara, Soe Soe Thwin, Hamsadvani Kuganantham, Moazzam Ali, Olufemi T Oladapo, Nathalie Broutet
• Journal: The Lancet. Global health (Lancet Glob Health) Vol. 9 Issue 3 Pg. e366-e371 (03 2021) ISSN: 2214-109X [Electronic] England
• PMID: 33340453 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
• Copyright: Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Topics

• Clinical Trials as Topic (ethics, standards)
• Eligibility Determination
• Female
• Humans
• Patient Selection (ethics)
• Pregnancy
• Pregnancy Complications, Infectious (drug therapy)
• SARS-CoV-2
• COVID-19 Drug Treatment