Women & Infants named lead center in 14-site study of cytomegalovirus

Women & Infants Hospital of Rhode Island, through its participation in the Maternal-Fetal Medicine Units Network, has been named the lead center in a 14-site, $25 million study of cytomegalovirus (CMV), the most common infection during pregnancy. Researchers want to see whether giving recently infected pregnant women antibodies against CMV lowers the rate of CMV infection in their babies. This study is funded by the National Institute of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Principal investigator is Brenna Anderson, MD, of the Division of Maternal-Fetal Medicine and the Integrated Program for High-Risk Pregnancy at Women & Infants Hospital and assistant professor of obstetrics and gynecology at The Warren Alpert Medical School of Brown University.

Dr. Anderson said, "Each year in the US, CMV infection affects more infants than Down syndrome and spina bifida combined. Yet until recently we have not been able to efficiently screen for it. Now that we can, we are in a position to test promising treatments."

CMV is a common virus spread like a cold or the flu. Approximately 1% of pregnant women will be infected with CMV for the first time, which results in a 40% chance that the fetus will also be infected. Fetuses who are infected with CMV are more likely to be born earlier than expected and develop problems such as hearing loss and learning disabilities.

The study will screen more than 150,000 women for evidence of primary CMV infection and randomize those who are positive to CMV hyperimmune globulin or placebo in an effort to decrease the risk of congenital CMV. This will be among the biggest trials done by the Maternal-Fetal Medicine Units Network in their 20+ year history.

Pregnant women with a single fetus who have not yet reached the 24th week of pregnancy are eligible to participate in this study. A small amount of additional blood will be taken from participants in conjunction with routinely scheduled prenatal blood testing (that is, the screening will minimize needle sticks).

"Screening will show a woman if she has been infected with CMV while pregnant, and she may then be eligible for the randomized treatment trial," said Dr. Anderson.

Source: Women & Infants Hospital