MOMS Trial - MOMS Trial

MOMS Trial

In February 2003, the National Institutes of Health began the Management of Myelomeningocele Study (MOMS). Three centers (Vanderbilt University, Children's Hospital of Philadelphia and the University of California at San Francisco) were chosen to participate in the study of 183 fetuses which were randomized, 91 for fetal repair and 92 for postnatal repair. The study took 8 years to complete at a cost of $22.5 million. Of the 1,087 fetuses and mothers initially screened for the study, 183 met all the inclusion criteria. The Children’s Hospital of Philadelphia treated 77 patients, University of California at San Francisco treated 54 and Vanderbilt University treated 52.

Prenatal surgery was done at the assigned center between 19 and 25 weeks of pregnancy. Deliveries for both groups were performed by C-section at the assigned MOMS Center at approximately 37 weeks of pregnancy. The infants in the postnatal surgery group had their spina bifida closed at the MOMS Center as soon as possible after delivery, usually within 48 hours.

Medical information on the mothers and babies were gathered throughout the study and follow-up of their progress continued until the child reached at least two and a half years of age. Two outcomes were considered. The first, at 12 months, was death or need for a ventricular shunt. The second, measured at 30 months, was a composite score of standardized tests for mental and motor development.