Spinal Dysraphism Clinical Trial
Official title:
Myelomeningocele Repair Randomized Trial
Spina bifida (myelomeningocele) is a complex birth defect in which a portion of the spinal cord is not fully developed. The overlying bones and skin are incompletely formed and the underdeveloped area of the spinal cord is exposed on the surface of the back. Spina bifida defects are closed soon after birth to prevent further damage to the spinal cord and nerves. The Management of Myelomeningocele Study (MOMS) is a research study comparing two approaches to the treatment of babies with spina bifida: surgery before birth (prenatal surgery) and the standard closure, surgery after birth (postnatal surgery).
Since 1997, more than 200 fetuses have had in utero closure of myelomeningocele by open
maternal-fetal surgery. Preliminary clinical evidence suggests that this procedure reduces
the incidence of shunt-dependent hydrocephalus and restores the cerebellum and brainstem to
more normal configuration. However, clinical results of prenatal surgery for myelomeningocele
are based on comparisons with historical controls and examine only efficacy, not safety. MOMS
will determine if intrauterine repair of fetal myelomeningocele at 19 to 25 weeks of
gestation improves outcomes as compared to standard postnatal repair. Outcomes assessed
include death, the need for ventricular decompressive shunting by one year of life and
neurologic function at 30 months of age.
One hundred eighty-three women, whose fetuses have spina bifida, were enrolled in the study
and randomized to have either prenatal surgery or postnatal surgery. After a central
screening process which included a medical record review, all women had an extensive baseline
evaluation that included ultrasound, MRI, physical exam, social work evaluation,
psychological screening, and education about spina bifida and prenatal surgery.
For women who were eligible following the central screening process, all screening, surgery
and follow-up visits were performed at one of three MOMS Centers. The mother, if eligible,
and her support person traveled (at the expense of the study) to the MOMS Center for
screening and randomization.
Women assigned to have prenatal surgery were scheduled for surgery within 1 to 3 days after
they were randomized. They stayed near the MOMS Center until they delivered. Women in the
postnatal group traveled back to their assigned MOMS Center to deliver. Both groups delivered
their babies by C-section around the 37th week of their pregnancies. Babies born to women in
the postnatal surgery group had their spina bifida defects closed when they were medically
stable, usually within 48 hours of birth.
Children and their parents returned to their assigned MOMS Center at 1 year and 2 ½ years of
age for follow-up evaluation. Motor function, developmental progress, and bladder, kidney,
and brain development were assessed.
The children were asked to return for an additional follow-up visit (MOMS2) between the ages
of 6-10 years. This follow-up is to determine whether children who received the surgery
before birth have better health and mental outcomes and live more independently and function
more safely and appropriately in daily life than those who received the surgery after birth.
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