A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele

作者：N. Scott Adzick, Elizabeth A Thom, Catherine Y. Spong, John W. III Brock, Pamela Katzen Burrows, Mark Paul Johnson, Lori J. Howell, Jody A. Farrell, Mary E. Dabrowiak, Leslie N. Sutton, Nalin M. Gupta, Noel B. Tulipan, Mary E. D'Alton, Diana L. Farmer · 发表于：New England Journal of Medicine · 年份：2011 · DOI：10.1056/nejmoa1014379 · 被引用次数：2265 · 研究领域：Spinal Dysraphism and Malformations、Fetal and Pediatric Neurological Disorders、Congenital gastrointestinal and neural anomalies

BACKGROUND: Prenatal repair of myelomeningocele, the most common form of spina bifida, may result in better neurologic function than repair deferred until after delivery. We compared outcomes of in utero repair with standard postnatal repair. METHODS: We randomly assigned eligible women to undergo either prenatal surgery before 26 weeks of gestation or standard postnatal repair. One primary outcome was a composite of fetal or neonatal death or the need for placement of a cerebrospinal fluid shunt by the age of 12 months. Another primary outcome at 30 months was a composite of mental development and motor function. RESULTS: The trial was stopped for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. This report is based on results in 158 patients whose children were evaluated at 12 months. The first primary outcome occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal-surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P<0.001). Actual rates of shunt placement were 40% in the prenatal-surgery group and 82% in the postnatal-surgery group (relative risk, 0.48; 97.7% CI, 0.36 to 0.64; P<0.001). Prenatal surgery also resulted in improvement in the composite score for mental development and motor function at 30 months (P=0.007) and in improvement in several secondary outcomes, including hindbrain herniation by 12 months and ambulation by 30 months. However, prenatal surgery w...