MMC Study Update
Multi-center Trial of Fetal Myelomeningocele (MMC) Repair: Management of Myelomeningocele Study (MOMS)
Michael Harrison, MD, Principal Investigator
NICHD has sponsored a 5-year multicenter, randomized, controlled trial of 200 patients which will compare the safety and efficacy of fetal surgical repair and traditional postnatal repair of open neural tube defects. Patients carrying a fetus diagnosed with spina bifida will be eligible for the prenatal surgery which will be performed between the 19th and 25th weeks of pregnancy. The study has two primary outcomes: death or the need for ventricular decompressive shunting by one year of life and a composite outcome of two measures, the Bayley Scale of Infant Development and distal somatosensory function and motor sensory assessment of level of lesion as compared to anatomic level. There are many secondary outcomes which look at maternal, neonatal and infant issues such as maternal death, maternal reproductive functioning at 30 months post delivery, neonatal death or stillbirth, prematurity and complications related to it, and appearance of the Chiari II, motor function and total days of hospitalization of the infant through 30 months of age. There are three participating centers, Children's Hospital of Philadelphia, Vanderbilt University Medical Center and the University of California at San Francisco.
The George Washington Biostatistics Center will serve as the Data and Study Coordinating Center. Those interested in finding out more about the study should contact Dr. Catherine Shaer, the Program Manager toll free at 1-866-ASK-MOMS or log onto the MOMS website at spinabifidamoms.com.