When it comes to medical research, pregnant and breastfeeding women are often excluded from clinical trials. This exclusion is typically done to protect the health of unborn babies and infants. However, this practice has resulted in a lack of reliable information on how medicines and treatments affect women and their babies, as highlighted in a recent Viewpoint published in The Lancet.
The absence of pregnant and breastfeeding women from research studies can lead to significant delays in understanding the safety and efficacy of treatments during pregnancy and lactation. This lack of data forces healthcare providers to make decisions without robust evidence, potentially impacting the health of both mothers and their children.
The authors of the Viewpoint propose several changes to current medical research guidelines to address this issue. They suggest allowing women to make informed decisions about birth control when participating in clinical trials, treating pregnancy and breastfeeding as distinct situations, and incorporating women’s perspectives in research planning. Additionally, they recommend implementing new regulations and incentives to encourage the inclusion of pregnant and breastfeeding women in studies.
By making these changes, the authors believe that the safety and health of women and their babies can be better safeguarded. Properly testing medical treatments on pregnant and breastfeeding women can provide valuable insights into the effects of these interventions on this population.
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 24 October 2025
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