NICHD’s Role in Advancing Research on Pregnant and Lactating Populations

By: Monica Lefton, Communications Manager, SWHR

“We must continue to work to change the culture to protect pregnant women through research and not from research,” said Dr. Diana Bianchi, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), during an October meeting of the Coalition to Advance Maternal Therapeutics (CAMT).

In her remarks, Dr. Bianchi walked coalition members through NICHD’s role in advancing research in pregnant and lactating populations, which includes but is not limited to:

• Helping establish the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) in 2016. While the Task Force charter expired in March 2021, the implementation of its recommendations continues.
• Supporting a revision of the Common Rule, a federal regulation governing the involvement of human subjects in research, which removed pregnant and lactating people from the list of “vulnerable populations” to attempt to reverse the default exclusion of this group from clinical trials.
• Establishing the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub, a national resource to conduct and foster therapeutics-focused research in obstetrics, lactation, and pediatrics.
• Fostering National Institutes of Health (NIH)-funded research that is specific to maternal health issues, including prenatal opioid withdrawals and AIDS management.
• Participating in the Inclusion of Pregnant and Lactating Persons in Clinical Trials Workshop hosted by the National Academies of Sciences, Engineering, and Medicine (NASEM) in June 2022 and participating in the ongoing review of the medicolegal and liability challenges of conducting research in these populations.
• Taking on a lead role in the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE), an NIH-wide initiative to address the preventable causes of maternal mortality and improve health for women before, during, and after delivery.

As Dr. Bianchi remarked, the COVID-19 pandemic served as a reminder about the importance of including pregnant and lactating populations and how their exclusion can be harmful. “We can’t let that happen again,” she said. “The main thing is to always be thinking about pregnant people.”

Looking to the future, Dr. Bianchi is hopeful. She noted the vast, largely untapped research potential of creating something like a centralized data bank of electronic health records (EHRs) for understanding the safety and efficacy of medications during pregnancy. She is eager to see other health organizations, such as the U.S. Food and Drug Administration (FDA), join NICHD in the continued dismantling of existing barriers to inclusive research through funding and new guidelines, and she would like to see more robust training available for the next generation of obstetricians, pediatricians, and pharmacologists. Ultimately, she said, improving public awareness of PRGLAC is fundamental for positively shifting the research landscape.

“The big issue is changing the culture. This should be a topic that everyone can agree on… We want pregnant people to be healthy and safe, we want their babies to be healthy and safe, but we can’t do that until we have more data.” 

Dr. Diana Bianchi

Learn more about PRGLAC, including what recommendations the Task Force made regarding research and the development of safe and effective therapies specific to pregnant women and lactating women here.