Update on the Management of Myelomeningocele Study (MOMS): the first 16 months

The Management of Myelomeningocele Study (MOMS) is a five-year multicenter randomized trial funded by the National Institute of Child Health and Human Development, a part of the National Instutuites of Health. This study is designed to compare the safety and efficacy of prental and postnatal closure of open neural tube defects. This is felt to be a critical study in the United States where several centers began performing the procedure in 1997 but for which there is very little scientific data to support it as a valid intervention. The protocol specifies that 200 women be enrolled in the trial, with 100 in each group. The Management of Myelo-meningocele Study began recruiting patients in mid February of 2003 and enrollment is slower than projected because of several unanticipted issues. The challenges inherent in performing this type of study are significant and are magnified because the study requires that patients randomized to prenatal surgery stay at the MOMS Center performing the procedure until they deliver their child. Many unanticipated problems have been encountered which affect enrollemnt and these will be discussed as will the solutions which have been found. In addition, baseline data will be presented on the patients screened as well as those enrolled to date.