, for the MOMS Investigators abstract BACKGROUND: A substudy of the Management of Myelomeningocele Study evaluating urological outcomes was conducted.METHODS: Pregnant women diagnosed with fetal myelomeningocele were randomly assigned to either prenatal or standard postnatal surgical repair. The substudy included patients randomly assigned after April 18, 2005. The primary outcome was defined in their children as death or the need for clean intermittent catheterization (CIC) by 30 months of age characterized by prespecified criteria. Secondary outcomes included bladder and kidney abnormalities observed by urodynamics and renal/bladder ultrasound at 12 and 30 months, which were analyzed as repeated measures. WHAT'S KNOWN ON THIS SUBJECT: Urologic outcomes of prenatal myelomeningocele closure have previously been reported. This study, however, represents a large, prospectively followed cohort of these patients and presents detailed findings of urologic outcomes. To our knowledge, this is the largest study of this type.
WHAT THIS STUDY ADDS:Our study is the only trial to compare urologic outcomes in children with myelomeningocele having undergone prenatal closure with those who had postnatal repair in a prospective and systematic manner. We report our findings at 12 and 30 months. Dr Brock participated in the conception of the study design and protocol development, and contributed to critical aspects of the conduct of this research including monitoring study implementation, progress, and data quality; promotion of patient recruitment; acquisition of data; supervision of clinical centers; and data analysis. Dr Brock provided significant intellectual contribution to the drafting and revision of this manuscript with regard to scientific content and form; Drs Carr and Adzick participated in study design and protocol development, and contributed to critical aspects of the conduct of this research including assessment of patient recruitment; monitoring center performance; oversight of data quality; and evaluation and analysis of data. Dr Carr provided significant intellectual contribution to the drafting and revision of this manuscript with regard to scientific content and form;