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.)

Cirurgia fetal no contexto atual

“…Por essas razões, o "National Institutes of Health (NIH)", nos EUA, patrocinou um estudo multicêntrico, prospectivo e randomizado comparando os desfechos entre as cirurgias pré-natal e pós-natal, que ficou conhecido como MOMS 33 . O estudo teve início em 2003 e foi interrompido em 2010, após recrutamento de 183 pacientes, devido à eficácia superior da cirurgia pré-natal em análise inicial.…”

Neuropathic bladders: Investigation and treatment through their lifetime

“…Although controversial, in-utero closure of the open neural tube defect may offer some advantages to the child, but the risks of preterm labor (13% delivered at less than 30 weeks gestation) and maternal health remain significant concerns. [7][8][9] An ambitious randomized trial of 183 patients has demonstrated decreased need for ventriculoperitoneal (VP) shunts, 7 as well as improved mental and motor development, decreased hind brain herniation, and improved ambulation by 30 months. 9 Urological outcomes were not part of the initial assessment, but a 2015 review of the Management of Myelomeningocele Study (MOMS) demonstrated no difference in the need for clean intermittent catheterization (CIC), but patients appeared to have less bladder trabeculation and fewer open bladder necks.…”

“…[7][8][9] An ambitious randomized trial of 183 patients has demonstrated decreased need for ventriculoperitoneal (VP) shunts, 7 as well as improved mental and motor development, decreased hind brain herniation, and improved ambulation by 30 months. 9 Urological outcomes were not part of the initial assessment, but a 2015 review of the Management of Myelomeningocele Study (MOMS) demonstrated no difference in the need for clean intermittent catheterization (CIC), but patients appeared to have less bladder trabeculation and fewer open bladder necks. 10 The long-term implications of this are unknown, but after a review of their results, the Children's Hospital of Philadelphia declared that 18.5% of children were toilet-trained, although they did not elaborate on controls.…”

Nuevos desafíos en cirugía fetal

“…Existe la hipótesis propuesta de los "dos golpes" para explicar la fisiopatología del MMC 19 . El primero estaría dado por la falla en el cierre del tubo neural con la consecuente Figura 1.…”

“…También demostró una mejoría importante en la función neuromotora, resultando en un 42% de independencia para caminar de los pacientes del grupo de cirugía fetal, comparado con 21% del grupo control. Además demostró una ausencia de herniación del cerebro posterior en 36% en el grupo de cirugía prenatal comparado con 4% en el grupo control 19 .…”