To view the original video and read the News Release, please go to http://www.nichd.nih.gov/news/releases/Pages/030911-MOMS-video.aspx
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TITLE SLIDE: NICHD logo Management of Myelomeningocele Study (MOMS) Interview Catherine Y. Spong, M.D. |
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GRAPHICS SLIDE : Why was the study undertaken? |
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Dr. Spong on camera |
Dr. Catherine Y. Spong: The National Institutes of Health held a workshop looking at fetal surgery, at the state of fetal surgery as well as fetal surgery for conditions where the condition that was being treated with the surgery was not lethal. Meaning, the baby would survive the pregnancy, such as is the case with spina bifida. At that time, there were a number of sites that were doing this surgery and offering this surgery to pregnant women, but there wasn't clear data that it was beneficial to the baby. And there was certainly risk—risk of preterm birth, risk of uterine rupture to the mother. So, the culmination of this NIH-sponsored workshop was that a trial needed to be undertaken to evaluate whether or not prenatal surgery for spina bifida was beneficial compared to the standard postnatal repair. |
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GRAPHICS SLIDE : What is spina bifida? |
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Dr. Spong on camera |
Dr. Spong: So spina bifida is simply an open spinal cord, and myelomeningocele is the most severe form of spina bifida. |
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GRAPHICS SLIDE : Myelomeningocele of the spinal cord: |
Dr. Spong: In myelomeningocele, the spinal defect causes the nerves to come out of the spinal cord, and often you'll have something called "hindbrain herniation," where the base part of the brain is actually pulled into the spinal column. |
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Dr. Spong on camera |
Dr. Spong: This can cause an increase in pressure in the baby's head. |
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GRAPHICS SLIDE : MOMS began in 2003 and recruitment ended in 2010 (follow-up is ongoing), enrolling pregnant women carrying a child with myelomeningocele at three locations nationwide. Participants were enrolled on a rolling basis, however, enrollment was stopped early. |
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Dr. Spong on camera |
Dr. Spong: The study was stopped early after 183 of the typically planned 200 patients were randomized. And this was because of a dramatic improvement of outcome for both primary outcomes at 12 months and at 30 months in the babies who had the surgery during pregnancy. |
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GRAPHICS SLIDE : What did the study find? |
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Dr. Spong on camera |
Dr. Spong: What the study found for the 12 month outcome was that there was a significant decline in death or the need for a shunt. Where that only occurred in about 68% of the babies who had the prenatal surgery, compared to 98% of the babies who had the postnatal repair. So about one-third reduction. At 30 months, there was a significant improvement in the score of both the mental and motor development. In addition, there was significant improvement in the baby's ability to walk independently, where 42% of the babies who had the prenatal surgery could walk independently or without devices, compared to only 21% in the babies with the standard postnatal repair. At 30 months of age, when looking at hindbrain herniation, about one-third of the babies who had the prenatal repair no longer had evidence of hindbrain herniation compared to only 4% in the postnatal repair group. So the hindbrain herniation was essentially gone for about a third of those patients. |
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GRAPHICS SLIDE : What makes MOMS unique? |
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Dr. Spong on camera |
Dr. Spong: This is the first time a fetal surgery has been undertaken for a condition that was not life-threatening. Meaning the baby typically survives the pregnancy, and the repair is done afterwards. |
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GRAPHICS SLIDE : Are there risks to fetal surgery for spina bifida? |
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Dr. Spong on camera |
Dr. Spong: I think it's important to remember that this is a major surgical procedure that's being carried out on the pregnant mother, and there certainly are risks and the study does show that. I believe that it's...although the results are very promising for the fetal outcomes, there were significant risks. |
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GRAPHICS SLIDE : What should pregnant women carrying a child with myelomeningocele consider? |
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Dr. Spong on camera |
Dr. Spong: Fetal surgery requires close monitoring of both the mom and the baby, both during the procedure itself, as well as after the procedure and throughout the duration of the pregnancy. It shouldonly be undertaken by experienced centers that have the multi-disciplinary teams necessary to really care best for both the mom and the baby and the experienced surgeons who know how to undertake these very delicate procedures. |
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GRAPHICS SLIDE : NICHD logo If you are a member of the media 301-496-5133 |
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