Principal Investigator:
Elizabeth Thom, Sc.D.
he Biostatistics Center serves as the Coordinating Center for MOMS the
'Management of Myelomeningocele Study, a multi-center randomized clinical
trial comparing prenatal closure of myelomeningocele defects with the
standard treatment which is closure after birth (postnatal
closure). Prenatal closure of these defects has been done via hysterotomy
since 1997, but there is little scientific data on the risks and benefits
of the procedure.
here are three participating medical institutions which are designated as
MOMS Centers: Children's Hospital of Philadelphia, Vanderbilt University
Medical Center and the University of California at San Francisco. Two
hundred women carrying a fetus with myelomeningocele will be enrolled with
100 being randomized to each arm; prenatal or postnatal
surgery. Recruitment is expected to start in the summer of
2002. Follow-up is planned for 12 and 30 months of age with the
possibility that a grant extension will be sought for an additional
follow-up evaluation at 5 years of age. Primary outcomes include death or
the need for ventricular decompressive shunting by one year of life and
measures of neurodevelopmental function at 30 months. Funded by NICHD,
1-U01-HD41665-01A1, 2002-2007.
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