Fetoscopic Neural Tube Defect Repair

Inclusion Criteria:

• Maternal age 18 years or older

• Capable of consenting for their own participation in the study

• Decision to have fetoscopic repair following counseling of all options

• Open spina bifida with the upper boundary between T1 and S1

• Gestational age between 24 0/7 to 26 6/7 weeks' gestation at the time of surgery

• Normal karyotype and/or normal chromosomal microarray by invasive testing. In thecase of a microdeletion, microduplication, or variant of uncertain significant, thedecision to include or exclude will be at the discretion of the PrincipalInvestigators.

• Absence of major cardiac anomalies confirmed by fetal echocardiogram

• Adequate social support throughout pregnancy

• Parental or guardian willingness to undergo follow-up evaluations of the child afterbirth

Exclusion Criteria:

• Multiple gestation

• Major fetal anomalies unrelated to the neural tube defect

• Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI

• Previous spontaneous singleton preterm birth prior to 37 weeks

• Presence of cervical cerclage at the time of surgery or history of cervicalinsufficiency

• Cervical length less than 20 mm by endovaginal ultrasound

• Placenta previa or evidence of placental abruption

• Technical factors such as large uterine fibroids, uterine anomalies, or fetalmembrane separation for which the risks of surgery are deemed to outweigh thebenefits

• Maternal obesity precluding surgical access with a BMI > 45 or if the PrincipalInvestigator determines the body habitus to be technically challenging

• Alloimmunization in pregnancy including Kell sensitization or a history of neonatalalloimmune thrombocytopenia

• Maternal HIV or Hepatitis B positive status. If the patient's HIV or Hepatitis Bstatus is unknown, the patient must be tested and found to be negative prior tosurgery

• Known Hepatitis C positivity. If the patient's Hepatitis C status is known, they donot need to be screened

• Maternal medical condition which is a contraindication to surgery or generalanesthesia. This includes previous hysterotomy in the active segment of the uterus

• Maternal medical co-morbidities which would significantly increase the risk ofspontaneous or iatrogenic preterm delivery

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

• Patient not meeting psychosocial criteria determined by fetal care social worked tocomply with the medical care and plan for follow ups

• Participation in another interventional study that influences maternal and fetalmorbidity and mortality

• Known history of hypersensitivity to collagen products or chondroitin materials