TRICARE Allows Expectant Mothers to Participate in Spina Bifida Study

In a case of spina bifida, the fetus' spine and spinal canal fail to close properly. In minor cases, that's all that's wrong. In more serious cases, the spinal cord's protective sheath, the meninges, herniates. In a case of myelomeningocele (pronounced my-uh-low-muh-NING-uh-seal), the severest form of spina bifida, both the cord and sheath herniate and protrude from the victim's back.

Although mild spina bifida is not usually life-threatening, babies born with myelomeningocele typically experience lifelong and sometimes devastating physical disabilities: weakness or paralysis in their lower limbs, numbness, loss of bladder and bowel control, and hydrocephalus (water on the brain), which causes mental retardation. Some children also have skeletal deformation, sexual dysfunction and mental impairment.

TRICARE, DoD's health care management agency, recently signed an agreement with the National Institute of Child Health and Human Development, which will permit female TRICARE beneficiaries whose pregnancies are complicated by myelomeningocele to participate in a clinical trial designed to study a new approach to treatment of this condition: intrauterine surgery.

"It is intuitively a good thing that we offer beneficiaries the opportunity to participate," said Col.(Dr.) Daniel Cohen, executive medical director, and director, Office of the Chief Medical Officer. "After all, this is a devastating condition which completely changes the life of an entire family forever in ways that most people will fortunately never experience."

About 100,000 babies are born each year to TRICARE beneficiaries. Cohen said statistics show spina bifida appears once in every 5,000 births. During the course of the enrollment period, expected to last 18 months, about 25 to 30 TRICARE beneficiaries may be eligible for enrollment, though there are strict agreement and enrollment criteria. The trial may not be suitable or desirable for all beneficiaries. This is experimental therapy.

The child health institute expects that 200 patients nationally will enroll in the trial during the enrollment period that begins in February. The trials will last a few years, Cohen said, while the infants are followed to assess their motor development, and bowel and bladder functions.

The trials will take place at three medical research centers, the University of California at San Francisco, Vanderbilt University Medical Center in Nashville, Tenn., and Children's Hospital of Philadelphia.

Researchers have found preliminary evidence that shows closing the open defect in the spine through intrauterine fetal surgery -- a procedure done while the baby is still in the womb -- may correct and possibly prevent some nerve damage and eliminate several abnormalities caused by disorder.

Cohen said results can be encouraging, but he warned of possible risks involved with the procedure.

"We hope to learn that the procedure is safe and effective for the baby and safe from the mother's perspective," he said. "The basis of all the research is to establish proof, statistically valid proof, that something really works and, more importantly, is more beneficial than the standard, currently accepted approach. It is conceivable that this intervention is less safe and less effective than the conventional treatment, even though conventional treatment is less than optimal."

Current treatment for the birth defect is to deliver the baby by cesarean section at about 36 weeks of gestation and repair the spinal defect at that time. Often many other surgical procedures are required during the life of affected infants.

The interagency agreement is the second one which the Department of Defense has developed with the National Institutes of Health to enable TRICARE beneficiaries to participate in experimental studies. The cost of DoD participation in the study is expected to be about $1.3 million over the next four years.