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 withvariants 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 neonatalalloimmune thrombocytopenia

• HIV or Hepatitis-B positive status

• Known Hepatitis-C positivity

• Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormalitythat is diagnosed via imaging prior to surgery, which that are unavoidable duringsurgery

• Other medical conditions which are contraindication to surgery or general anesthesia

• Patient does not have a support person

• Inability to comply with the travel and follow-up requirements of the trial

• Patient does not meet psychosocial standardized assessment criteria

• Participation in this or another intervention study that influences maternal andfetal morbidity and mortality

• Maternal hypertension

• Zika virus positivity

• Allergy/history of drug reaction to Amphotericin B

Fetal exclusion criteria:

• Major fetal anomaly not related to spina bifida

• Kyphosis in the fetus of 30 degrees or more

• Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints