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Management of Myelomeningocele (MOMS) Study
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An Introduction to MOMS
The MOMS study results are in -- prenatal surgical repair has now been shown to significantly reduce neurological damage caused by spina bifida. Learn more about the Birth of a Breakthrough »
MOMS is a national clinical trial comparing two treatment approaches to spina bifida -- prenatal surgical repair versus postnatal surgical repair. This playlist provides an overview of the study and the patient experience by members of the MOMS steering committee and clinicians in the participating centers.
Transcript: An Introduction to MOMS
Mary E. D'Alton, MD: MOMS is a short name for Management of Myelomeningocele Study. And the overarching goal of this study is to determine the role of maternal fetal surgery for therapy of children with myelomeningocele.
Elizabeth A. Thom, PhD: Comparing the standard of care which is postnatal surgery with this new treatment, which is prenatal surgery.
Diana Farmer, MD: The MOMS study began initially as the outgrowth of work that had been done in animals.
N. Scott Adzick, MD: There was evidence that there was ongoing damage to the spinal cord before birth.
Edmund Y. Yang, MD: So then the next question was, "could we cover that up and prevent that progressive damage?"
N. Scott Adzick, MD: So after a lot of thinking and peer review, several groups -- the group at Vanderbilt and the group at The Children's Hospital of Philadelphia and the group at The University of California San Francisco -- began to do myelomeningocele repairs in human fetuses before birth.
Diana Farmer, MD: And our initial experiences with human patients were, in fact, a little different than the expected outcome that we saw from our initial animal studies. Some things weren't as good as we anticipated and some things were better.
Mary E. D'Alton, MD: But there were many problems with that in that we were not able to evaluate for certain whether this type of surgery improved the survival and the outcome for these children. Dr. Alexander who was director of NICHD had the vision to bring the research community together in 2000 to review the state of the medical and surgical experience at that time. It then became clear that a randomized clinical trial was necessary.
N. Scott Adzick, MD: So it was time to put the concept to the test to compare fetal repair of myelomeningocele side-by-side with conventional standard myelomeningocele repair after birth and look at outcomes.
Elizabeth A. Thom, PhD: For this trial, we have two separate primary outcomes. One is measured at 1 year of age and it's whether a child needs a shunt or not. And the other one is measured at 2.5 years of age and it looks at the neurodevelopmental status of the child as well as whether the child can walk better than expected or do other functional things better than expected given where the spina bifida lesion is on the spine.
N. Scott Adzick, MD: There are a whole variety of secondary research questions. One is to evaluate the issue of hindbrain herniation; whether it completely resolves with fetal repair, for instance, as judged by postnatal MRI. There are a whole variety of neurologic parameters that are being tested in the children, particularly at the one year and two-and-a-half year follow-up times. And also some important questions with regard to the parents in terms of psychological well-being with fetal surgery, in terms of the future reproductive potential of the mothers who undergo fetal myelomeningocele repair compared to conventional care.
Mary E. D'Alton, MD: The Center for Biostatistics at George Washington University has had an enormous amount of experience and credibility in dealing with trials of pregnant women.
Elizabeth A. Thom, PhD: It's important to have an independent group, people who aren't doing the procedures who don't have any vested interest in whether it's better or not, doing the data analysis.
Diana Farmer, MD: They collect all of the data. They keep track of all the data. They coordinate the panel of experts that reviews all of the X-rays, all of the ultrasounds, all of the MRIs.
Edmund Y. Yang, MD: They screen the patients preliminarily to make sure that they would meet criteria to enter the trial and then they refer them to the other three centers for evaluations.
Mary E. D'Alton, MD: The three clinical centers have been at the forefront of fetal therapy in the United States for the last two decades. So they are enormously qualified to perform this kind of investigation.
Diana Farmer, MD: It wouldn't be possible, of course, without the support of the NIH through the NICHD.
Mary E. D'Alton, MD: The National Institute of Child Health brings enormous credibility to the trial. They have the infrastructure. They have the data safety monitoring systems in place that are so established for many other trials that they are conducting. So it has provided the vision, the leadership, the funding, and the oversight to do this as safely and as quickly as possible for families here in the United States.
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