The Management of Myelomeningocele Study (MOMS) is a multi-center unblended randomized clinical trial of 200 patients that is underway at three clinical centers, the University of California-San Francisco, The Children's Hospital of Philadelphia, and Vanderbilt University Medical Center, and the George Washington University Biostatistics Center as the Data and Study Coordinating Center. The primary objective of the trial is to determine whether intrauterine repair of fetal myelomeningocele at 190 to 256 weeks gestation improves outcome, as measured by 1) death or the need for ventricular decompressive shunting by one year of life, and 2) a composite neurologic function score at 30 months corrected age. ? ? Only a small percentage of children with spina bifida are born with a normal innervation of their bladder and sphincter muscles, with urologic sequelae that are life-long. The effect of prenatal surgery for myelomeningocele on subsequent urologic function is unknown, but vitally important to determine. This proposal is for a supplement to the MOMS trial to initiate a more rigorous urologic follow-up of the infants in the trial. It is anticipated that 120 infants will receive renal sonography, video urodynamics and urinalysis, culture and sensitivity at three time points during the study: before neonatal discharge following delivery, at 12 months, and 30 months corrected age.
The aim of the supplement is to determine whether in utero treatment of open myelomeningocele affects the outcome with respect to urinary tract infection, and the need for intermittent catheterization. A committee of independent pediatric urologists will review medical records and imaging studies to determine whether infants meet objective criteria for clean intermittent catheterization. ? ? The George Washington University Biostatistics Center will serve as the Data and Study Coordinating Center for this supplement. We will collaborate on study design, revise the protocol and manual of operations, prepare case report forms, arrange publicity, update and maintain the data management system and study internal and external internet sites. We will continue to serve as the central screening and referral site, and we will coordinate the centralized outcome review, as well as the long term follow-up visits conducted at the three centers. ? ?
| Farmer, Diana L; Thom, Elizabeth A; Brock 3rd, John W et al. (2018) The Management of Myelomeningocele Study: full cohort 30-month pediatric outcomes. Am J Obstet Gynecol 218:256.e1-256.e13 |
| Antiel, Ryan M; Adzick, N Scott; Thom, Elizabeth A et al. (2016) Impact on family and parental stress of prenatal vs postnatal repair of myelomeningocele. Am J Obstet Gynecol 215:522.e1-6 |
| Johnson, Mark P; Bennett, Kelly A; Rand, Larry et al. (2016) The Management of Myelomeningocele Study: obstetrical outcomes and risk factors for obstetrical complications following prenatal surgery. Am J Obstet Gynecol 215:778.e1-778.e9 |
| Brock 3rd, John W; Carr, Michael C; Adzick, N Scott et al. (2015) Bladder Function After Fetal Surgery for Myelomeningocele. Pediatrics 136:e906-13 |
| Tulipan, Noel; Wellons 3rd, John C; Thom, Elizabeth A et al. (2015) Prenatal surgery for myelomeningocele and the need for cerebrospinal fluid shunt placement. J Neurosurg Pediatr 16:613-20 |
| Adzick, N Scott; Thom, Elizabeth A; Spong, Catherine Y et al. (2011) A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med 364:993-1004 |
