Note: CTSI's Pediatric Clinical Research Center, managed by the Clinical Research Services program, supported this study with nursing services, sample lab support, and extensive developmental testing of the children by a psychologist.
The Society of Clinical Trials has named UCSF’s Management of Myelomeningocele Study (MOMS), a review of prenatal versus postnatal surgery for myelomengingocele (spina bifida), as its Trial of the Year.
The study earned recognition as an important clinical trial that overcame difficulties and produced remarkable results.
Since 2008, the Society has presented an award to the randomized clinical trial that meets a range of criteria, including providing the basis for substantial, beneficial change in health care to overcoming obstacles for implementation.
Published in The New England Journal of Medicine in March 2011, the MOMS trial was stopped because of superior results with the prenatal surgery after 183 patients enrolled (out of a planned 200). The primary outcome of fetal or neonatal death, or the need for placement of a cerebrospinal shunt by one year of age, occurred in 68% of those undergoing prenatal surgery and 98% of those undergoing postnatal surgery.
According to the Society of Clinical Trials, the MOMS trial faced great difficulties in recruiting women who had recently received a devastating diagnosis, entailing counseling and providing considerable information and resources about options and ethical considerations. Those randomized to prenatal surgery needed to remain close to the participating clinical center. The effort required to overcome the many obstacles in the conduct of this important trail was a key factor in its selection as Trial of the Year.
Learn more about the award, including the selection process and past recipients.