The federally sponsored Management of Myelomeningocele Study (MOMS), co-led by experts at Children’s Hospital of Philadelphia, reported results of a clinical trial of fetal surgery for myelomeningocele, the most severe form of spina bifida.
The randomized, controlled clinical trial was initiated and funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The trial’s results directly compared outcomes of prenatal surgery versus postnatal repair in 183 patients.
The study showed that fetal surgery for spina bifida greatly reduces the need to divert fluid from the brain, improves mobility and improves the chances that a child will be able to walk independently.
Two and a half years after fetal surgery, children with spina bifida were better able to walk, when compared to children who received surgery shortly after birth. Patients who received fetal surgery also scored better on tests of motor function. Within a year after fetal surgery, they were less likely to need a shunt, a surgically implanted tube that drains fluid from the brain.
Specifically, the study found that prenatal repair resulted in:
- Reduced need for ventricular shunting (a procedure in which a thin tube is introduced into the brain’s ventricles to drain fluid and relieve hydrocephalus), as measured at 12 months of age
- Reduced incidence or severity of neurologic effects caused by the spine’s exposure to amniotic fluid, such as impaired motor and sensory function of the legs
- Improved ambulation, as measured at 30 months of age
- Reversal of the hindbrain herniation component of the Chiari II malformation
The trial demonstrated that outcomes after prenatal spina bifida treatment are improved to the degree that the benefits of the surgery outweigh the maternal risks. Study results were published in February 2011 in The New England Journal of Medicine.
For more information:
Follow-up through 2 1/2 years of age for study participants was completed in October 2013.
Prenatal repair of myelomeningocele. Source: N. Scott Adzick, MD et al., “A Randomized Trial of Prenatal versus Postnatal Repair of Myelomeningocele,” N Engl J Med. 2011 Mar 17;364(11):993-1004. Epub 2011 Feb 9.
Phase two of the Management of Myelomeningocele Study (MOMS 2) is underway under the continued coordination of the Biostatics Center of The George Washington University and the sponsorship of Eunice Kennedy Shriver NICHD.