Extended Criteria for fetal myelomeningocele (MMC) repair
The Management of Myelomeningocele Study (MOMS) was a clinical trial that demonstrated that fetal surgery for spina bifida was beneficial to the outcome of the baby, however, it had a very strict inclusion and exclusion criteria. This was done to minimize the risk associated with the new treatment. Recently, this strict inclusion/exclusion criteria under the MOMS trial has been questioned. Typically, using criteria established by the Management of Myelomeningocele Study (MOMS), fetal repair of spina bifida defects would be limited to mothers whose BMIs are less than 35 kg/m2, do not have diabetes, did not have a previous preterm birth, do not have a condition known as maternal-fetal Rh alloimmunization, and to babies with additional structural abnormalities. This incorporation was to minimize risk, and to rule out additional complications that may have been associated with the new therapy. However, risk-benefit evaluations for these additional patient populations in the context of fetal surgery for MMC is unknown. In this observational pilot trial, the Fetal Center offers MMC fetal repair to patients utilizing the MOMS criteria with a BMI extension of less than or equal to 40, to babies with some minor structural abnormalities, to patients with controlled diabetes, to patients having specific types of alloimmunization, and to patients that delivered a baby at full-term following a pre-term spontaneous delivery of one baby. This study will allow us to document and analyze retrospective and prospective longitudinal data on all maternal-fetal pairs diagnosed with myelomeningocele with extended MOMS criteria. It will allow us to better counsel families, and to develop a larger, definitive, multi-center trial. For more information about the study, please contact the study’s Principal Investigator, Kuojen Tsao, MD, at firstname.lastname@example.org or 713-500-7300, or The Fetal Center at 832-325-7520.