Sunday, December 31, 2017

The management of myelomeningocele study

Farmer DL, Thom EA, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Gupta N, Adzick NS; MOMS Investigators. The Management of Myelomeningocele Study: Full cohort 30 month pediatric outcomes. Am J Obstet Gynecol. 2017 Dec 12.  pii: S0002-9378(17)32475-4. doi: 10.1016/j.ajog.2017.12.001. [Epub ahead of print]

Previous reports from the Management of Myelomeningocele Study (MOMS) demonstrated that prenatal repair of myelomeningocele reduces hindbrain herniation, the need for cerebrospinal fluid shunting, and improves motor function in children with myelomeningocele. The trial was stopped for efficacy after 183 patients had been randomized, but 30-month outcomes were only available at the time of initial publication in 134 mother-child dyads. Data from the complete cohort for the 30-month outcomes are presented here. Maternal and 12-month neurodevelopmental outcomes for the full cohort have been reported previously.

The purpose of this study is to report the 30 month outcomes for the full cohort of patients randomized to either prenatal or postnatal repair of myelomeningocele in the original Management of Myelomeningocele Study (MOMS).

Eligible women were randomly assigned to undergo standard postnatal repair or prenatal repair before 26 weeks gestation. We evaluated a composite of mental development and motor function outcome at 30 months for all enrolled patients as well as independent ambulation and the Bayley II Scales of Infant Development (BSID-II). We assessed whether there was a differential effect of prenatal surgery in subgroups defined by: fetal leg movements, ventricle size, presence of hindbrain herniation, gender, and location of the myelomeningocele lesion. Within the prenatal surgery group only, we evaluated these and other baseline parameters as predictors of 30-month motor and cognitive outcomes. We evaluated whether presence or absence of a shunt at 1 year was associated with 30-month motor outcomes.

The data for the full cohort of 183 patients corroborates the original findings of MOMS, confirming that prenatal repair improves the primary outcome composite score of mental development and motor function (199.4 ± 80.5 versus 166.7 ± 76.7, p=0.004). Prenatal surgery also resulted in improvement in the secondary outcomes of independent ambulation (44.8% versus 23.9%, p = 0.004), WeeFim® Self-Care score (20.8 versus 19.0, p=0.006), functional level at least 2 better than anatomic level (26.4% versus 11.4%, p=0.02), and mean Bayley II Psychomotor Development Index (17.3% versus 15.1%, p=0.03), but does not affect cognitive development at 30 months. On subgroup analysis, there was a nominally significant interaction between gender and surgery, with boys demonstrating better improvement in functional level and PDI. For patients receiving prenatal surgery, the presence of in utero ankle, knee, and hip movement, absence of a sac over the lesion and a myelomeningocele lesion of L3 or lower were significantly associated with independent ambulation. Postnatal motor function showed no correlation with either prenatal ventricular size or postnatal shunt placement.

The full cohort data of 30-month cognitive development and motor function outcomes validate in utero surgical repair as an effective treatment for fetuses with myelomeningocele. Current data suggest that outcomes related to the need for shunting should be counseled separately from the outcomes related to distal neurologic functioning.

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