MOMS Trial
Encyclopedia
The MOMS Trial is a Eunice Kennedy Shriver National Institute of Child Health and
Human Development (NICHD) sponsored study of prenatal and postnatal closure of myelomeningocele; a collaboration of The Children's Hospital of Philadelphia, the University of California at San Francisco, Vanderbilt University Medical Center in Nashville and the George Washington University in Washington, D.C.
For decades the standard treatment has been to close the spinal defect soon after the baby is born. This is called postnatal surgery. Recently doctors have developed an experimental operation performed while the baby is still in the mother’s womb. This is called prenatal surgery. Prenatal surgery may improve the outcome of babies born with spina bifida.
Human Development(NICHD), a part of the National Institutes of Health (NIH), has sponsored this cooperative study between The Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania, the University of California at San Francisco in San Francisco, California, and Vanderbilt University Medical Center in Nashville, Tennessee. Each of these hospitals has experience in prenatal surgery and is a designated MOMS Center.
Two hundred (200) women carrying a baby with spina bifida were to be enrolled in the study. Half would be enrolled in the group to have prenatal surgery and half in the group to have postnatal surgery. This was a randomized trial, which means that neither the doctors involved in the study nor the women participating in the study were able to choose who had prenatal and who had postnatal surgery.
Women were assigned to a particular MOMS Center based on geographic location and the need to divide the study participants evenly among the three centers. Prenatal surgery was done at the assigned center between 19 and 25 weeks of pregnancy. Deliveries for both groups were performed by C-section at the assigned MOMS Center at approximately 37 weeks of pregnancy. The infants in the postnatal surgery group had their spina bifida closed at the MOMS Center as soon as possible after delivery, usually within 48 hours.
Medical information on the mothers and babies were gathered throughout the study and follow-up of their progress continued until the child reached at least two and a half years of age. Analysis of this information helped scientists determine if the prenatal or postnatal surgery is better for infants with spina bifida.
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. Results were reported in the New England Journal of Medicine by Adzick et al.
Specifically, the study found that prenatal repair resulted in:
Based on these outcomes, fetal repair of spina bifida is now considered a standard of care. However, prenatal repair is a complex and challenging procedure, requiring the most expert, comprehensive care for both mother and fetus. The surgical team’s level of experience in all aspects of care surrounding the operation are of paramount importance.
Human Development (NICHD) sponsored study of prenatal and postnatal closure of myelomeningocele; a collaboration of The Children's Hospital of Philadelphia, the University of California at San Francisco, Vanderbilt University Medical Center in Nashville and the George Washington University in Washington, D.C.
Introduction
Myelomeningocele, also known as spina bifida, is a birth defect for which the causes are not well understood. Doctors believe that both genetic and environmental factors play a role. During the first 28 days of a pregnancy, the brain and spinal cord form in the developing baby. When normal development of the spinal cord is interrupted, spina bifida results. The majority of babies with spina bifida have a variety of medical problems including some amount of paralysis of the lower part of their body (this ranges from very mild to quite severe), loss of control of their bowels and bladder, and abnormalities of the brain.For decades the standard treatment has been to close the spinal defect soon after the baby is born. This is called postnatal surgery. Recently doctors have developed an experimental operation performed while the baby is still in the mother’s womb. This is called prenatal surgery. Prenatal surgery may improve the outcome of babies born with spina bifida.
MOMS
The MOMS (Management of Myelomeningocele Study) was a special type of research study called a clinical trial. It was designed to compare prenatal with postnatal surgery in an effort to find out if either treatment is better. At the time the study began, doctors did not know which type of surgery was best. The Eunice Kennedy Shriver National Institute of Child Health andHuman Development(NICHD), a part of the National Institutes of Health (NIH), has sponsored this cooperative study between The Children’s Hospital of Philadelphia in Philadelphia, Pennsylvania, the University of California at San Francisco in San Francisco, California, and Vanderbilt University Medical Center in Nashville, Tennessee. Each of these hospitals has experience in prenatal surgery and is a designated MOMS Center.
Two hundred (200) women carrying a baby with spina bifida were to be enrolled in the study. Half would be enrolled in the group to have prenatal surgery and half in the group to have postnatal surgery. This was a randomized trial, which means that neither the doctors involved in the study nor the women participating in the study were able to choose who had prenatal and who had postnatal surgery.
Women were assigned to a particular MOMS Center based on geographic location and the need to divide the study participants evenly among the three centers. Prenatal surgery was done at the assigned center between 19 and 25 weeks of pregnancy. Deliveries for both groups were performed by C-section at the assigned MOMS Center at approximately 37 weeks of pregnancy. The infants in the postnatal surgery group had their spina bifida closed at the MOMS Center as soon as possible after delivery, usually within 48 hours.
Medical information on the mothers and babies were gathered throughout the study and follow-up of their progress continued until the child reached at least two and a half years of age. Analysis of this information helped scientists determine if the prenatal or postnatal surgery is better for infants with spina bifida.
Outcomes of the Trial
The MOMS trial was closed for efficacy in December 2010 based on comparing outcomes after prenatal and postnatal repair in 183 patients.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. Results were reported in the New England Journal of Medicine by Adzick et al.
Specifically, the study found that prenatal repair resulted in:
- Reversal of the hindbrain herniation component of the Chiari II malformation
- 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)
- Reduced incidence or severity of potentially devastating neurologic effects caused by the spine’s exposure to amniotic fluid, such as impaired motor function
Based on these outcomes, fetal repair of spina bifida is now considered a standard of care. However, prenatal repair is a complex and challenging procedure, requiring the most expert, comprehensive care for both mother and fetus. The surgical team’s level of experience in all aspects of care surrounding the operation are of paramount importance.
External links
- Official MOMS Trial website
- The Children's Hospital of Philadelphia
- Children's Hospital at Vanderbilt
- University of California, San Francisco
- MOMS Summary on Clinicaltrials.gov
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Eligibility Guidelines for Fetal Surgery for Spina Bifida Center for Fetal Diagnosis and Treatment | The Children's Hospital of Philadelphia