While nearly every pregnant person in the United States reports taking at least one medication during pregnancy, over two-thirds of clinical trials explicitly exclude enrollment of pregnant people. The results of clinical trials provide clinicians with vital information on the safety and efficacy of medications, which is used to guide evidence-based decision- making. During pregnancy, the body undergoes substantial changes in the way it processes substances, which suggests the potential for differential drug safety profiles in pregnant vs. non-pregnant people.
Without this information, clinicians and pregnant people often struggle to make decisions about which medications to prescribe and continue in pregnancy. Most recently this was evident with the COVID-19 vaccine, in which a lack of information lead to a months-long delay in professional organizations recommending the COVID-19 vaccine for pregnant people, resulting in increased avoidable death and illness.
If pregnant people were included in COVID-19 vaccine clinical trials, clinicians would have been better equipped to provide evidence-based counseling regarding vaccination. Many pregnant people who were hesitant to be vaccinated against COVID-19 felt this way due to a lack of research on COVID-19 vaccine safety in pregnancy. Pregnant people want to do what is best for themselves and their babies and including them in clinical trials will empower them with the information to do so.
Kretz AM, Casubhoy I, Tan H, Morgan R. (2023). Protect the health of pregnant people : Commit to the inclusion of pregnant people in clinical trials in the United States, Gender & COVID-19 Working Group. June 2023.