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Researchers debate inclusion of pregnant, chestfeeding people in clinical trials

Mid-section portrait of unrecognizable woman during last months of pregnancy holding her big belly gently standing against wall in blue room

Mid-section portrait of unrecognizable woman during last months of pregnancy holding her big belly gently standing against wall in blue room

Pregnant and lactating people are rarely included in clinical trials out of fear for how medications may affect their developing and newborn babies. But that creates quite a challenge for physicians.

Some 4 million people in the United States give birth each year, and about 70 percent of those individuals take at least one prescription medication. Without knowledge of the risks and benefits of certain medicines, doctors and patients are often left guessing the best treatment plans.

Last summer, the National Academies of Science, Engineering, and Medicine’s Forum on Drug Discovery, Development, and Translation convened a workshop to discuss the “barriers and opportunities for including these populations in clinical trials.”

Two Indiana University Department of Obstetrics and Gynecology faculty members were among the medical professionals invited to participate: Brownsyne Tucker Edmonds, MD, an associate professor of obstetrics and gynecology, took part in the workshop as a planning committee member; and David Haas, MD, the Robert A. Munsick Professor of Obstetrics and Gynecology and vice chair of research for the OB-GYN department, was a speaker.

The goal of the workshop was to "develop a framework for addressing liability issues when planning or conducting research with pregnant and lactating women,” according to a published summary. Conversations and presentations centered on topics like the laws governing medical research; the liability of including pregnant and lactating women in clinical trials; and the opportunities to improve evidence gathering in this population. Results will serve to inform an upcoming consensus study by the National Academies.

As a member of the planning committee, Tucker Edmonds helped develop the workshop’s agenda and invite experts and stakeholders in the field to join as speakers.

Tucker Edmonds is nationally and internationally recognized for her work in medical disparities, shared decision-making and periviable care. She leads advocacy and policy efforts for Indiana’s chapter of the American College of Obstetricians and Gynecologists.

Haas was among experts chosen to present during the workshop. As a practicing OB-GYN physician-scientist, his research interests revolve around prevention and treatment of medical and obstetric complications. He has a particular focus on medications and pregnancy and on long-term health outcomes stemming from pregnancy complications for both the pregnant individuals and their babies.

Haas’ presentation during the workshop focused on the gaps in evidence for clinicians prescribing drugs during pregnancy and lactation.

He told those attending that in addition to there being a general lack of information on this topic, there’s also little to no information on the use of multiple prescription medications during pregnancy or the use of medication during the postpartum period. Additionally, there is a lack evidence on whether medication can transfer to the child during breast- or chestfeeding and what potential long-term health outcomes there might be for the child.

Yet, forgoing treatments for preexisting or pregnancy-related health conditions expose a pregnant person and developing child to certain risks and adverse health outcomes, Haas told the workshop.

One key takeaway from the workshop was that pregnant and lactating people should be able to decide for themselves whether to participate in clinical trials.

Now, these discussions will be studied further. A full summary of the workshop can be found online.

The views expressed in this content represent the perspective and opinions of the author and may or may not represent the position of Indiana University School of Medicine.
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Caitlin VanOverberghe

Caitlin VanOverberghe is a communications coordinator for the Indiana University School of Medicine, where she supports the Department of Orthopaedic Surgery and the Department of Ophthalmology. Having earned degrees in journalism and telecommunications ...