Safe and Equitable Strategies to Reduce the Impact of Congenital Cytomegalovirus on Mothers and Children

Andrea Ciaranello, MD, MPH
Andrea Ciaranello, MD, MPH
MGH Research Scholar 2022-2027
Physician Investigator, Medical Practice Evaluation Center
Associate Professor of Medicine, Harvard Medical School

Each year, 120,000 pregnant women and 30,000 infants in the U.S. acquire congenital cytomegalovirus (CMV), and more than 800,000 infants worldwide are affected. There are marked racial/ethnic, socioeconomic, and geographic disparities in congenital CMV incidence and outcomes. Although most infants are asymptomatic, CMV can cause premature delivery and low birthweight; after birth, it can lead to severe illness, including sepsis, neurologic impairment, vision loss and seizures. Congenital CMV is the leading non-genetic cause of hearing loss in children, affecting up to 8,000 infants in the U.S. annually. In addition to these health impacts, lifetime care for an infant with symptomatic CMV can cost up to $4 million.

Despite the major clinical and economic impacts of congenital CMV, the best approach to preventing, diagnosing and treating CMV in pregnant women and infants remains uncertain. Assays used to detect CMV in pregnancy are imperfect. False negative results lead to missed opportunities for evaluation and treatment, while false positive results lead to unnecessary procedures—including amniocentesis and pregnancy termination—as well as substantial anguish for patients and families. Once CMV is diagnosed in pregnant women or infants, promising therapies are under investigation, but their efficacies are unknown, and each carries risks of toxicity to women and infants.

Congenital CMV is a rapidly evolving field—researchers are evaluating new diagnostic tests, therapies and vaccine candidates, all with the potential to dramatically reduce severe morbidity and costs of care. More research is needed to deploy these technologies in a way that makes the best use of limited health care resources, prioritizes equity, and avoids unnecessary procedures and complications. Many of these questions cannot be answered using traditional clinical trials or study designs.

Our team in the Medical Practice Evaluation Center uses innovative simulation modeling methods to link maternal and infant outcomes in order to understand the clinical and economic value of strategies to care for pregnant women and their infants. Our work in HIV has directly informed national and international guidelines. The MGH Research Scholar award will support the expansion of this research into the critically important and rapidly evolving field of congenital CMV.