Many clinical trials exclude women who are pregnant, breastfeeding, or able to become pregnant. This is often done to protect the health of unborn babies and infants, but it means there is little reliable information about how medicines and treatments affect these women and their babies, according to a Viewpoint published in The Lancet.
Excluding these populations from research can lead to delays in understanding what treatments are safe and effective during pregnancy and breastfeeding. As a result, doctors must make decisions without strong evidence, which can affect the health of mothers and their children.
The authors recommend changes to medical research guidelines, such as allowing women to make their own informed decisions about birth control when joining clinical trials, treating pregnancy and breastfeeding as separate situations, and including women’s perspectives in planning research. They also suggest new rules and incentives to encourage studies that include pregnant and breastfeeding women.
The authors say these changes can help improve the safety and health of women and their babies by ensuring that medical treatments are properly tested for them.
More information:
Lana Moayad et al, Inclusion of women who are pregnant, lactating, or of reproductive potential in clinical trials: health, ethical, and regulatory considerations, The Lancet (2025). DOI: 10.1016/s0140-6736(25)01497-7
Citation:
Researchers call for more pregnant and breastfeeding women to be included in medical research (2025, October 24)
retrieved 25 October 2025
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