Clinical trials and pregnancy

Catriona Waitt; Denise Astill; Eleonor Zavala; Ruth A Karron; Ruth R Faden; Pamela Stratton; Sarah M Temkin; Janine A Clayton

doi:10.1038/s43856-022-00198-1

Clinical trials and pregnancy

Commun Med (Lond). 2022 Oct 25:2:132. doi: 10.1038/s43856-022-00198-1. eCollection 2022.

Authors

Catriona Waitt¹, Denise Astill^{2

3}, Eleonor Zavala⁴, Ruth A Karron⁴, Ruth R Faden⁵, Pamela Stratton⁶, Sarah M Temkin⁶, Janine A Clayton⁶

Affiliations

¹ University of Liverpool, Liverpool, UK.
² Foetal Anti-Convulsant Syndrome New Zealand, PO Box 82-175, Highland Park, Auckland, 2143 New Zealand.
³ Consumer Advocacy Alliance, PO Box 32 445, Devonport, Auckland, 0744 New Zealand.
⁴ Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, 615 N. Wolfe St, Baltimore, MD 21205 USA.
⁵ Berman Institute for Bioethics, Johns Hopkins University, 1809 Ashland Avenue, Baltimore, MD 21205 USA.
⁶ Office of Research on Women's Health, National Institutes of Health, Building 10, Room 7-4647, 10 Center Dr., Bethesda, Maryland 20892 USA.

Abstract

Traditionally, there has been a reluctance to involve pregnant people in clinical trials due to complex ethical issues surrounding the risk to unborn babies. However it is crucial that new interventions are safe and effective for all patients and ensuring this can be difficult to achieve in the absence of clinical trials.

Keywords: Reproductive biology; Reproductive disorders; Toxicology.