Management of Myelomeningocele Study (MOMS) (MOMS)
Meningomyelocele, Spinal Dysraphism
About this trial
This is an interventional treatment trial for Meningomyelocele focused on measuring Maternal fetal surgery, Fetal diagnosis, Myelomeningocele, Meningomyelocele, Open neural tube defect, ONTD, Spina bifida
Eligibility Criteria
Inclusion Criteria Pregnant women carrying a fetus diagnosed with myelomeningocele Myelomeningocele lesion that starts no higher than T1 and no lower than S1 with hindbrain herniation present Gestational age at randomization of 19 weeks 0 days to 25 weeks 6 days Normal karyotype Singleton pregnancy United States resident Able to travel to study site for study evaluation, procedures, and visits (if randomized to prenatal surgery, must stay near center until delivery) Support person to travel and stay with participant Exclusion Criteria Maternal insulin-dependent pregestational diabetes Short or incompetent cervix or cervical cerclage Placenta previa Body mass index of 35 or more Previous spontaneous delivery prior to 37 weeks Maternal HIV, Hepatitis-B or Hepatitis-C status positive Uterine anomaly Maternal medical condition which is a contraindication to surgery or general anesthesia Other fetal anomaly
Sites / Locations
- University of California at San Francisco
- The Children's Hospital of Philadelphia
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Prenatal Surgery Group
Postnatal Surgery Group
Fetal surgery to close spina bifida defect prior to 26 weeks of gestation with delivery by C-Section at approximately 37 weeks of gestation.
Standard postnatal closure of the spina bifida defect when the baby is medically stable, usually within 48 hours of birth by C-section.