GW Researchers Coordinate Study of Fetal Surgery to Reduce Complications of Spina Bifida
WASHINGTON – Researchers at The George Washington University Medical Center played a key role in a National Institutes of Health (NIH) study of a surgical procedure to repair a common birth defect of the spine, which if undertaken while a baby is still in the uterus, greatly reduces the need to divert, or shunt, fluid away from the brain. The study was published online in the New England Journal of Medicine on February 9, 2011.
The multi-center clinical trial, called the Management of Myelomeningocele Study (MOMS), was coordinated by researchers at The George Washington University Biostatistics Center. Their work included study design, setting up the study website and randomization system, screening and evaluating patients, creating case report forms and manuals of procedures, quality control and management of the data, statistical analysis of the data, and organization of outcome reviews and follow-up teams.
"GW’s role was to make sure the study was conducted to the highest standards possible, the data were as accurate as possible, and the analysis was conducted in the most appropriate manner,” said Elizabeth Thom, Ph.D., Principal Investigator for the Data and Study Coordinating Center of MOMS and Associate Director of The George Washington University Biostatistics Center. “The goal was to ensure that the study results can inform future clinical practice.”
The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The Children’s Hospital of Philadelphia (CHOP), the University of California San Francisco (UCSF) and Vanderbilt University Medical Center in Nashville served as the clinical centers for the study.