Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2022 Jan;88(1):7-21.
doi: 10.1111/bcp.14914. Epub 2021 May 30.

Ethical issues in therapeutic use and research in pregnant and breastfeeding women

Ethel D Weld  1 , Theodore C Bailey  2 , Catriona Waitt  3   4
Affiliations
Free article
Review

Ethical issues in therapeutic use and research in pregnant and breastfeeding women

Ethel D Weld et al. Br J Clin Pharmacol. 2022 Jan.
Free article

Abstract

Pregnant or potentially pregnant women have historically been excluded from clinical trials of new medications. However, it is increasingly recognised that it is imperative to generate evidence from the population in whom the drugs are likely to be used to inform safe, evidence-based shared clinical decision making. Reluctance by researchers and regulators to perform such studies often relates to concerns about risk, particularly to the foetus. However, this must be offset against the risk of untreated disease or using a drug in pregnancy where safety, efficacy and dosing information are not known. This review summarises the historical perspective, and the ethical and legal frameworks that inform the conduct of such research, then highlights examples of innovative practice that have enabled high quality, ethical research to proceed to inform the evidence-based use of medication in pregnancy.

Keywords: drug development; ethics; pregnancy; research in special populations.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

REFERENCES

    1. Vargesson N. Thalidomide-induced teratogenesis: history and mechanisms. Birth Defects Res C Embryo Today. Jun 2015;105(2):140-156. https://doi.org/10.1002/bdrc.21096
    1. Lyerly AD, Little MO, Faden R. The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth Fall. 2008;1(2):5-22. https://doi.org/10.1353/ijf.0.0047
    1. Onakpoya IJ. Rare adverse events in clinical trials: understanding the rule of three. BMJ Evid Based Med. Feb 2018;23(1):6. https://doi.org/10.1136/ebmed-2017-110885
    1. Karlsson Lind L, von Euler M, Korkmaz S, Schenck-Gustafsson K. Sex differences in drugs: the development of a comprehensive knowledge base to improve gender awareness prescribing. Biol Sex Differ. 2017;8(1):32-40. https://doi.org/10.1186/s13293-017-0155-5
    1. Lupattelli A, Spigset O, Twigg MJ, et al. Medication use in pregnancy: a cross-sectional, multinational web-based study. BMJ Open. 2014;4(2):1-11, e004365. https://doi.org/10.1136/bmjopen-2013-004365

Publication types

Grants and funding