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.
This research study is funded by the NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development.
For more information, call (401) 274-1122, extension 8523 or visit womenandinfants.org.
About Women & Infants Hospital
Women & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation's leading specialty hospitals for women and newborns.A U.S.News Best Hospital in Gynecology and Best Children's Hospital in Neonatology, Women & Infants was ranked number one in the Providence metro area and a top-performer in cancer, and has achieved a 5-star rating in Maternity Care for 2011 from HealthGrades.The primary teaching affiliate of The Warren Alpert Medical School of Brown University for obstetrics, gynecology and newborn pediatrics, as well as a number of specialized programs in women's medicine, Women & Infants is the eighth largest stand-alone obstetrical service in the country with nearly 8,400 deliveries per year.In 2009, Women & Infants opened the country's largest, single-family room neonatal intensive care unit.
New England's premier hospital for women and newborns, Women & Infants and Brown offer fellowship programs in gynecologic oncology, maternal-fetal medicine, urogynecology and reconstructive pelvic surgery, neonatal-perinatal medicine, pediatric and perinatal pathology, gynecologic pathology and cytopathology, and reproductive endocrinology and infertility.It is home to the nation's only mother-baby perinatal psychiatric partial hospital, as well as the nation's only fellowship program in obstetric medicine.
Women & Infants has been designated as a Breast Center of Excellence from the American College of Radiography; a Center for In Vitro Maturation Excellence by SAGE In Vitro Fertilization; a Center of Biomedical Research Excellence by the National Institutes of Health; and a Neonatal Resource Services Center of Excellence.It is one of the largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics in the nation, and is a member of the National Cancer Institute's Gynecologic Oncology Group and the National Institutes of Health's Pelvic Floor Disorders Network.
See story on WJAR-TV10.