作者: Noel Tulipan , John C. Wellons , Elizabeth A. Thom , Nalin Gupta , Leslie N. Sutton
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摘要: OBJECT The Management of Myelomeningocele Study (MOMS) was a multicenter randomized trial comparing the safety and efficacy prenatal postnatal closure myelomeningocele. stopped early because demonstrated surgery, outcomes on 158 183 pregnancies were reported. Here, authors update 1-year for complete trial, analyze primary related outcomes, evaluate whether specific prerandomization risk factors are associated with surgery benefit. METHODS outcome composite fetal loss or any following: infant death, CSF shunt placement, meeting prespecified criteria placement. Primary outcome, actual revision rates versus repair compared. reassessed to determine which most concordant practice, new created from by replacing original placement revised criteria. used logistic regression estimate there interactions between type known (lesion level, gestational age, degree hindbrain herniation, ventricle size) shunting among those infants who underwent surgery. RESULTS Ninety-one women 92 repair. occurred in 73% group 98% (p < 0.0001). Actual only 44% 84% 2 groups, respectively commonly met criterion require overt clinical signs increased intracranial pressure, defined as split sutures, bulging fontanelle, sunsetting eyes, addition increasing head circumference hydrocephalus. Using these modified criteria, 3 patients each but did not receive shunt. For difference groups: 49.5% 87.0% There also significant reduction number children had placed then required 1 year age (15.4% vs 40.2%, relative 0.38 [95% CI 0.22-0.66]). In group, 20% size 10 mm at initial screening, 45.2% up 15 mm, 79.0% ≥ received shunt, whereas 79.4%, 86.0%, 87.5%, respectively, = 0.02). Lesion level herniation appeared have no effect eventual need 0.19 p 0.13, respectively). Similar results obtained outcome. CONCLUSIONS Larger ventricles screening an undergoing During counseling, care should be exercised recommending when larger does appear improve this group. may useful guidelines treating hydrocephalus