Since 1997, 180 fetuses have had in utero closure of myelomeningocele (MMC) by open fetal surgery. Preliminary clinical evidence suggests that this procedure reduces the incidenceof shunt-dependent hydrocephalus and restores the cerebellum and brainstem to more normalconfiguration. However, clinical results of fetal surgery for MMC are based on comparisons with historical controlsand examineonly efficacy and not safety. The Myelomeningocele Repair RandomizedTrial is a multi-center unblindedrandomized clinical trial of 200 patients that will be conducted at three Fetal SurgeryUnits (FSU), the University of California-San Francisco, Children's Hospital of Philadelphia, and Vanderbilt University Medical Center, along with an independent Data and Study Coordinating Center, the George Washington UniversityBiostatisticsCenter. The primary objective of the trial is to determine if inrrauterine repair of fetal myelomeningocele at 18' to 25' weeks gestation improves outcome, as measured by 1)death or the need for ventricular decompressive shunting by one year of life and 2) death or Bayley Mental Development Index, as compared to standard postnatalrepair Consenting patients who satisfy eligibilitycriteria will be centrallyrandomizedto either intrauterineor standardpostnatal repair of the MMC. Patientsassigned to the fetal surgery group will be discharged to nearby accommodationfollowing surgery, unless infeasible, in which case they will return to their assigned FSU at 32^ weeks gestation fordelivery at 3?0 weeks gestation by cesarean section. Patients assigned to the postnatal surgery group will return homeand at 37^ weeks, return to their assigned FSU for deliveryby cesarean section. Magnetic Resonance Imaging will beconducted at enrollment,discharge or term gestation, and one year of age to determine if intrauterine repair improves thedegree of the Chiari II malformation. Neonatal morbidity will be recorded as will the number of surgical procedures forconditions related to the MMC, musclestrength,ambulation status and urinary and fecal continence. Infants will makefollowup visits at twelve and thirty monthscorrected age for detailed neurbmotor function analysis, cognitive testing andevaluation of neurodevelopmental status. In addition, the long term psychosocial and reproductive consequences inmothers will be evaluated. In summary, the proposed trial will be able to demonstrate whether fetal intervention offers improved outcome with areasonable quality of life for spina bifida children.
| 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 |
