Fetoscopic NEOX Cord 1K® Spina Bifida Repair

Inclusion Criteria: Maternal inclusion criteria: * Singleton pregnancy * Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks * Maternal age: 18 years and older * Body mass index \< 40 kg/m2 * No preterm birth risk factors (short cervix, history of previous preterm delivery) * No previous uterine incision in the active uterine segment * Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful Fetal inclusion criteria: * Spina bifida defect between T1 to S1 vertebral levels * Chiari II malformation * No evidence of kyphosis (curved spine) * No major life-threatening fetal anomaly unrelated to spina bifida * Normal karyotype, or normal Chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance Exclusion Criteria: Maternal exclusion criteria: * Non-resident of the United States * Multifetal pregnancy * Poorly controlled insulin-dependent pregestational diabetes * Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes * Current or planned cerclage or documented history of an incompetent cervix * Placenta previa or placental abruption * Short cervix of \< 20 mm * Obesity as defined by a body mass index of \> 40 kg/m2 * Previous spontaneous singleton delivery prior to 37 weeks * Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia * HIV or Hepatitis-B positive status * Known Hepatitis-C positivity * U…