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New Minimum Criteria for U.S. Fetal Centers Established by Specialty Task Force to Ensure Optimal Patient Outcomes, Safety

New Minimum Criteria for U.S. Fetal Centers Established by Specialty Task Force to Ensure Optimal Patient Outcomes, Safety

HOUSTON (January27, 2014)

In a recently issued opinion, the myelomeningocele (MMC) Maternal-Fetal Management Task Force has established a new set of minimum criteria for centers providing open fetal myelomeningocele, or spina bifida, repair.

Myelomeningocele, the most common and the most severe form of spina bifida, is a birth defect in which the bony spine and spinal canal do not close before birth. According to the American College of Obstetricians and Gynecologists (ACOG), it occurs in approximately one in 1,500 births in the United States. Symptoms may include buildup of fluid inside the skull (hydrocephalus), loss of bladder or bowel control, partial or complete lack of sensation in the lower body, abnormal positioning of the feet, partial or complete paralysis of the legs, and learning or developmental difficulties.

Based on the findings of the Management Of Myelomeningocele Study (MOMS Trial) funded by the National Institute of Child Health and Human Development, the ACOG recently recommended that patients with a fetus with spina bifida, and who meet a specific set of criteria, undergo counseling regarding the risks and benefits of maternal-fetal surgery. In addition, the committee emphasized the importance of only having the surgery performed “at facilities with the expertise, multidisciplinary teams, services, and facilities to provide the intensive care required for these patients.”

The MOMS Trial was an eight-year, multi-center study that researched the difference in outcomes between prenatal and postnatal closure of spina bifida – meaning surgery on the fetus while still in the mother’s womb versus surgery soon after the baby is born. The results of the trial, which were published in early 2011, found an overwhelming benefit to having the surgery performed prenatally. Specifically, babies who received prenatal treatment were half as likely to require a ventricular shunt and twice as likely to walk independently by 30 months as the babies who received the surgery post-birth.

Thanks to the MOMS Trial’s promising findings, it is now anticipated by maternal-fetal medicine experts that an increasing number of affected pregnant patients will be willing to accept the risks associated with prenatal repair and, with that, will soon come an increased number of centers offering this highly skilled, in utero procedure. This task force was created to answer pressing clinical issues such as how to maintain expertise amid the predicted expansion and what the standard should be for centers offering this repair.

“Postnatal repair for spina bifida may still be the most common treatment but an increasing number of patients are electing to proceed with maternal-fetal surgery,” said Anthony Johnson, D.O., Co-Director of the Texas Fetal Center at Children's Memorial Hermann Hospital, Professor of Maternal-Fetal Medicine at UTHealth Medical School, and member of the MMC Maternal-Fetal Management Task Force. “We were the first in Texas to conduct fetal surgery for spina bifida and as this alternative therapy continues to gain popularity with parents, it is paramount that the centers providing this care abide by these recommended standards in order to maintain both patient safety and optimal, quality outcomes.”

Among the new criteria developed by the task force: fetal spina bifida repairs should only be performed in established centers that employ a multidisciplinary team approach; fetal surgery team must have experience working together and individual members must have a level of expertise in their field; the level of expertise demanded requires an adequate, annual volume of cases to maintain competency; new programs must receive guidance and training from established programs; MOMS protocol should be followed in all stages of care with few exceptions; ongoing care should be performed in multidisciplinary spina bifida clinics; counseling should be full disclosure and nondirective in nature, followed by a 24-hour reflective period; outcome data from all centers should be kept in a national registry with periodic review and a collaborative approach to reporting and research should be maintained; and close links between centers and community providers are essential.

“These recommendations are meant to encourage medical and surgical leadership and foster responsibility among the maternal-fetal medicine community,” said Johnson. “By clearly defining these key areas of care, we are able to establish a new, nationwide standard for all fetal centers offering in utero repair for spina bifida – a standard that ensures best practice is being followed to assure maximum benefit with minimum risk to both the mother and developing baby.”

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About the Texas Fetal Center
The Texas Fetal Center is a leader in providing diagnosis, treatment and complete care for mothers with high-risk pregnancies and babies with congenital anomalies or genetic conditions. The multidisciplinary team is the most experienced at providing comprehensive fetal diagnosis and intervention in the Southwest, and its members are world leaders in laser ablation in Twin-Twin Transfusion Syndrome (TTTS) — performing over 300 laser ablation cases — and performed the first fetal spina bifida repair in the region. The team is the first Extracorporeal Membrane Oxygenation (ECMO) center in Texas, and also the first in Texas to perform the Ex-utero Intrapartum Treatment (EXIT) procedure. The center is a national leader in research studies, being one of only eight centers nationally to be included in the NICHD Network. The center, located in the Texas Medical Center, is a collaboration between Children’s Memorial Hermann Hospital and The University of Texas Health Science Center at Houston Medical School. Learn more about the Texas Fetal Center as well as the maternal-fetal surgery for spina bifida.

About Children’s Memorial Hermann Hospital
Children’s Memorial Hermann Hospital is a 278-bed hospital dedicated to pediatric and neonatal care with an additional 68 beds dedicated to women’s services. The hospital’s special compassion and healing expertise has distinguished it as one of the finest children’s hospitals in the nation. In partnership with the University of Texas Health Science Center at Houston Medical School, Children’s Memorial Hermann specialists provide care for more than 120,000 patient visits annually, including the tiniest premature infants, children and adolescents. Memorial Hermann takes a holistic approach to healthcare, offering programs and services that address the physical, social, psychological and spiritual aspects of well-being. An integrated health system, Memorial Hermann is known for world-class clinical expertise, patient-centered care, leading-edge technology and innovation. The system, with its exceptional medical staff and 22,000 employees, serves southeast Texas and the greater Houston community. Learn more about Children’s Memorial Hermann Hospital.