The National Institute of Child Health and Human Development (NICHD) will conduct a large study to determine whether a new surgery to correct spina bifida in the womb is safer and more effective than the traditional surgery to correct the disorder, which takes place a few days after birth.
Spina bifida is a complex, often severe birth defect of the spinal cord that affects one of every 1000 pregnancies in the United States. In this condition, the spinal cord and the bones of the spinal column may fail to develop normally. With the most severe form of spina bifida, myelomeningocele, the spinal cord may be exposed through an opening in the bones of the spinal column. This may result in partial or complete paralysis of the area below the spinal opening. The paralysis may be so severe that an affected individual may be unable to walk and may experience incontinence of the urine and stool. Also, in many individuals affected by spina bifida, the brain may be positioned further down into the upper spinal column than it should be. This may result in a blockage of the cerebrospinal fluid, the fluid that bathes the brain and spinal cord. This blockage leads to a build up of fluid that could damage the brain. The blockage is treated by surgically implanting a hollow tube, or shunt in the child's brain to drain the excess fluid into the abdominal cavity.
"This lifelong disability exacts a terrible physical, emotional and financial toll," said Duane Alexander, M.D., Director of the NICHD. "This study will test whether a new treatment can improve on an existing technique."
The study, called the Management of Myelomeningocele Study, or MOMS, will recruit 200 pregnant women carrying fetuses with myelomeningocele. The women will be assigned at random to one of the two treatment groups. One treatment is the traditional therapy where the children born will have the spinal column closed surgically, after birth. The other treatment will be performed between the 19th and 25th weeks of pregnancy. A surgeon taking part in the study will make an incision in the woman's uterus, and surgically close the spinal defect of the fetus she is carrying. The women in both groups will undergo a cesarean section at the 37th week of pregnancy. For the women in the prenatal surgery group, cesarean delivery is necessary to prevent injury to the uterus, which had been opened surgically. Cesarean delivery is required for the second group as well, to prevent the stresses of the birth process from damaging the infant's spinal column. All infants born to women in the study will be evaluated at 12 and 30 months of age and the study scientists will carefully observe the development of the two groups of children, looking specifically at whether a shunt is needed, and at bladder and motor function. The impact of the prenatal surgery on the women will also be evaluated.
To determine whether they are eligible for the study, women who wish to volunteer will undergo a preliminary evaluation by the George Washington University Biostatistics Center, which will coordinate the study. Women who are eligible for the study will be referred to one of the three participating MOMS Centers for further screening and evaluation: The Children's Hospital of Philadelphia, Vanderbilt University Medical Center, and the University of California at San Francisco.
The three institutions participating in the study have undertaken preliminary studies of the new technique on more than 230 patients. It remains unknown, however, whether this surgical technique is more effective than the traditional therapy to close the spinal column after birth.
Since January 1998, the U.S. Food and Drug Administration has required food manufacturers to fortify certain grain products with the vitamin folic acid, to reduce the risk of spina bifida and related conditions, known collectively as neural tube defects. Also in 1998, the Institute of Medicine recommended that all women of childbearing age receive 400 micrograms of folic acid each day. The naturally occurring form of folic acid-folate-occurs in beans, leafy green vegetables, and citrus fruits. Although consuming adequate amounts of the vitamin greatly reduces the risk that a woman will conceive a child with a neural tube defect, the vitamin does not eliminate the risk completely.
The study is currently recruiting. Further information about the study is available at 1-866-ASK-MOMS and online at fetus.ucsf.edu/research/spina-bifida-moms-trial .
The NICHD is part of the National Institutes of Health (NIH), the biomedical research arm of the federal government. NIH is part of the U.S. Department of Health and Human Services. The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. NICHD publications, as well as information about the Institute, are available from the NICHD Web site, http://www.nichd.nih.gov, or from the NICHD Information Resource Center, 1-800-370-2943; e-mail NICHDIRC@mail.nih.gov.