MANAGEMENT OF MYELOMENINGOCELE (MOMS)
Principal Investigator: Elizabeth Thom, Ph.D.
Co-Investigator: Pamela Katzen Burrows, M.S.
The Biostatistics Center serves as the Coordinating Center for MOMS the 'Management of Myelomeningocele Study, a multi-center randomized clinical trial comparing prenatal closure of myelomeningocele defects with the standard treatment which is closure after birth (postnatal closure). Recruitment started in February 2003.
There are three participating medical institutions which are designated as MOMS Centers: Children's Hospital of Philadelphia, Vanderbilt University Medical Center and the University of California at San Francisco. One hundred eighty-three women carrying a fetus with myelomeningocele were enrolled with equal randomization to each arm; prenatal or postnatal surgery. Follow-up takes place at 12 and 30 months of age and will continue through 2013. Primary outcomes include death or the need for ventricular decompressive shunting by one year of life and measures of neurodevelopmental function at 30 months. The study was stopped early for efficacy in December 2010. Preliminary results were reported in the New England Journal of Medicine in February 2011. Funded by NICHD, U01-HD041665, 2002-2012.)