For decades, pregnant women and children have largely been excluded from clinical trials due to concerns about the viability of the unborn child, the safety of novel medications for children, and legal and ethical issues regarding vulnerable populations. In fact, less than 1% of clinical trials enroll pregnant participants, according to a study published last spring in the American Journal of Obstetrics and Gynecology.
Since 2021, through a grant funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indiana University School of Medicine has been working with the Ohio State University (OSU) as the research and data coordinating center for the Maternal and Pediatric Precisionin Therapeutics (MPRINT) Hub, to improve pediatric and maternal research outcomes.
Clinical trial design assistance and training available
MPRINT was established, in part, to support recommendations of the Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC) and the Best Pharmaceuticals for Children Act. The MPRINT Hub has been engaged with pediatric, obstetric and gynecologic researchers nationally to bridge knowledge gaps through training, study design assistance, pharmacometric modeling, centralized listings of biobanks, collating clinical study data and outreach events. MPRINT also provides support to MPRINT’s two designated Centers of Excellence: Vanderbilt University Medical Center and University of California San Diego.
Additionally, the MPRINT teams at IU and OSU are providing project management and data support for eight working groups involved in the "Prioritization of Therapeutic Research Needs for Pregnant, Postpartum and Lactating (PPL) Persons" PRGLAC initiative.
“One of the goals is balancing safety and risk in these populations and understanding we’re protecting our patients through research, not from research, to understand both the benefit and risk,” said Sara Quinney, PharmD, PhD, professor of obstetrics and gynecology and MPRINT site director at IU School of Medicine. “It’s definitely an area that is understudied, but I think we have a small and growing community of passionate researchers who are trying to fill the gaps and improve outcomes.”
IU School of Medicine faculty who are using MPRINT as a resource include Maternal-Fetal Medicine Division Director Christina M. Scifres, MD, and Anna E. Thomas, MD, assistant professor of clinical pediatrics, who are studying pharmacokinetics of caffeine at delivery with a goal of facilitating treatment of apnea in preterm newborns.
Erin M. Cleary, MD, assistant professor of clinical obstetrics and gynecology, also sought MPRINT’s assistance on study design for her lactation studies related to pharmacokinetics, which measure plasma changes to understand how a medication is absorbed, distributed and metabolized in the body.
“We know that medications are used every day in pregnant women and in children, but that there is incomplete understanding of some of the nuances of how we may need to prescribe differently in those populations,” said David Haas, MD, the Robert A. Munsick Professor of Obstetrics & Gynecology, who serves on MPRINT’s internal advisory committee. “The great thing about MPRINT as a resource for both clinicians and researchers is that they are a central resource to help collate existing data and to help design the best possible studies to answer key questions that providers need when prescribing drugs for pregnant women and for children.”
Four research cores facilitate data collection and training
The Indiana University-Ohio State University MPRINT Data and Model Knowledge Research Coordination Center (DMKRCC) is co-led by Quinney and Lang Li, PhD, professor and chair of the department of biomedical informatics at OSU School of Medicine. The center provides logistic and scientific support for MPRINT Hub and its collaborators throughout the maternal-pediatric community through four specialized cores:
- Knowledgebase Portal — a database of maternal-pediatric therapeutics research that has been curated by humans and artificial intelligence to support identification of research gaps and opportunities.
- Pharmacometrics and Clinical Trial Design Core — a pharmacometrics research core that supports study design and PK/PD data analysis for research partners, including the Maternal-Fetal Medicine Units Network, Pediatric Trials Network and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, as well as individual investigators.
- Real-World Evidence Core — a maternal-child database in development across Indiana and Ohio to examine long-term effects of medications administered during pregnancy, bringing together data from Regenstrief Institute, Nationwide Children’s Hospital, OSU and Cincinnati Children’s Hospital.
- Outreach and Education Core — a resource that hosts educational and innovative research webinars and conferences, recordings of which may be viewed on the MPRINT YouTube channel.
“The work of the knowledgebase, the clinical centers focused on breastfeeding and genetics and the modeling core all are making impacts in clinical care daily,” Haas said.
As part of the NICHD grant, Quinney's group established a knowledgebase supplement — the Collaborative Online Perinatal and Pediatric Repository, known as COPPER. This centralized repository, established by the MPRINT team alongside maternal fetal medicine units and biorepositories, serves as a resource for researchers searching for available biospecimens that fit their needs. Haas serves as the principal investigator, with the support of Chris E. Philip, MD, a postdoctoral fellow in obstetrics and gynecology.
“If they needed plasma from first, second and third trimester women and cord blood, they could go to COPPER,” Quinney said. “It provides a resource where people can go and find rare specimens with the goal of being able to use all these specimens that we’ve collected over many years and help increase our sample numbers for rare diseases.”
Quinney said MPRINT is a great resource for anyone who is planning to do research related to maternal pediatric therapeutics. “If you’re putting in a grant for clinical study, working with our team can provide some critical insight and suggestions that may improve your study design,” Quinney said, noting they can bring in expertise in subspecialties in maternal and pediatric research as needed.
MPRINT plans to co-host its annual conference with the Indiana Clinical and Translational Sciences Institute on April 13-17, 2026, in conjunction with the Indiana CTSI Pharmacometrics Modeling Simulation Symposium in Indianapolis. The conference is open to anyone interested in maternal and pediatric research, and registration will be available in the months ahead.
“I encourage fellows and junior faculty and trainees to attend,” Quinney said. “It’s an excellent learning and networking opportunity."
The MPRINT Coordinating Center at IU School of Medicine is supported by staff and faculty alike, including Amelia Grant, MSW, LCSW, MPRINT program manager; Emily Kinney, PhD, scientific writer; Kevin McClelland and Paulette Kiley, who support grant administration; and faculty, students and fellows in the Division of Clinical Pharmacology, Department of Pediatrics and Purdue University Department of Pharmacy Practice.
The MPRINT Hub is open to new partnerships and collaborations, including from the IU School of Medicine community. Faculty and learners can email the MPRINT Coordinating Center to get started.
