title: A randomized trial of prenatal versus postnatal repair of myelomeningocele.
abstract: 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 was associated with an increased risk of preterm delivery and uterine dehiscence at delivery.
  
  
  CONCLUSIONS
  Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00060606.).
authors.affiliation: Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA. adzick@email.chop.edu
authors.forename: N Scott
authors.initials: NS
authors.lastname: Adzick
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Thom
authors.forename: Catherine Y
authors.initials: CY
authors.lastname: Spong
authors.forename: John W
authors.initials: JW
authors.lastname: Brock
authors.forename: Pamela K
authors.initials: PK
authors.lastname: Burrows
authors.forename: Mark P
authors.initials: MP
authors.lastname: Johnson
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Howell
authors.forename: Jody A
authors.initials: JA
authors.lastname: Farrell
authors.forename: Mary E
authors.initials: ME
authors.lastname: Dabrowiak
authors.forename: Leslie N
authors.initials: LN
authors.lastname: Sutton
authors.forename: Nalin
authors.initials: N
authors.lastname: Gupta
authors.forename: Noel B
authors.initials: NB
authors.lastname: Tulipan
authors.forename: Mary E
authors.initials: ME
authors.lastname: D'Alton
authors.forename: Diana L
authors.initials: DL
authors.lastname: Farmer
mesh_terms: D002557:Cerebrospinal Fluid Shunts; D002675:Child, Preschool; D004677:Encephalocele; D005260:Female; D005313:Fetal Death; D005315:Fetal Diseases / Q000601:surgery*; D046128:Fetal Therapies / Q000379:methods; D005333:Fetus / Q000601:surgery*; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D020883:Hysterotomy; D007223:Infant; D007224:Infant Care; D007226:Infant Mortality; D007231:Infant, Newborn; D007360:Intelligence; D057194:Intention to Treat Analysis; D008297:Male; D008591:Meningomyelocele / Q000150:complications / Q000401:mortality / Q000601:surgery*; D011183:Postoperative Complications; D011247:Pregnancy; D016896:Treatment Outcome; D016138:Walking