Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic 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 ≤45 kg/m2 (pre-pregnancy)
• No preterm birth risk factors (short cervix <20 mm or a 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 a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance [fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks].

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 > 45 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
• Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery
• 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 and fetal 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