Clinical trials and pregnancy

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.

PMID: 36299562
PMCID: PMC9593973
DOI: 10.1038/s43856-022-00198-1

Clinical trials and pregnancy

Catriona Waitt et al. Commun Med (Lond). 2022.

. 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.

PMID: 36299562
PMCID: PMC9593973
DOI: 10.1038/s43856-022-00198-1

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.

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Conflict of interest statement

Competing interestsThe authors declare no competing interests.

Figures

See this image and copyright information in PMC

References

1. Shields KE, Lyerly AD. Exclusion of pregnant women from industry-sponsored clinical trials. Obstet. Gynecol. 2013;122:1077–1081. doi: 10.1097/AOG.0b013e3182a9ca67. - DOI - PubMed
1. Weld ED, et al. Ethical issues in therapeutic use and research in pregnant and breastfeeding women. Br. J. Clin. Pharmacol. 2021;88:7–21. doi: 10.1111/bcp.14914. - DOI - PubMed
1. Lyerly AD, et al. Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project. J. Int. AIDS Soc. 2021;24:e25846. doi: 10.1002/jia2.25846. - DOI - PMC - PubMed
1. Krubiner CB, et al. Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response. Vaccine. 2021;39:85–120. doi: 10.1016/j.vaccine.2019.01.011. - DOI - PMC - PubMed
1. Kons, KM et al. Exclusion of reproductive-aged women in COVID-19 vaccination and clinical trials. Women’s Health Issues10.1016/j.whi.2022.06.004 (2022). - PMC - PubMed

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Clinical trials and pregnancy

Affiliations

Clinical trials and pregnancy

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

LinkOut - more resources

Full Text Sources