A new federally funded study in the University of Florida College of Pharmacy will evaluate the safety of contrast agents used during magnetic resonance imaging, or MRI, scans of pregnant women.
The FDA awarded a $330,000 grant to Almut Winterstein, Ph.D., a professor and the Dr. Robert and Barbara Crisafi Chair of Pharmaceutical Outcomes and Policy, to lead the 18-month study.
Gadolinium-based contrasting agents, or GBCAs, are intravenous drugs administered to patients who undergo MRI procedures. These contrast agents help improve visualization of internal organs, blood vessels and tissues during an MRI and enhance the ability to diagnose many different medical conditions. From 2008 to 2015, it is estimated that one in every 421 pregnant women was exposed to a GBCA-enhanced MRI.
“Gadolinium is a heavy metal and known to deposit in various body tissues. It can cross the placenta, which raises concerns about potential effects on fetal development,” Winterstein said. “Our study will evaluate the safety of GBCA-enhanced MRIs and the risk for stillbirth or neonatal death.”
UF researchers will study the outcomes of more than 6,000 pregnancies, including an anticipated 300 stillbirths, exposed to an MRI. The research findings are expected to help the FDA decide whether any regulatory action should be taken to mitigate the risk of use of GBCAs during pregnancy.