In-Utero Endoscopic Correction of Spina Bifida

Eligibility Criteria

• 1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.
• 2. Maternal age ≥18 years.
• 3. Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.
• 4. Balanced karyotype and/or normal mircoarray with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.
• 5. Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.
• 6. Positive evaluation from pediatric neurology consult.
• 7. Willing to return to our center, or to a multi-disciplinary spina bifida clinic closer to their home for the 6, 12, 24, 30, 48, and 60 months follow-up evaluations.
• 1. Multiple gestation
• 2. Insulin-dependent pregestational diabetes
• 3. Presence of a fetal anomaly not related to Chiari II Malformation. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.
• 4. Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.
• 5. Presence of uterine cervical cerclage or history of incompetent cervix.
• 6. Placenta previa or placental abruption.
• 7. Short cervix \< 25 mm measured by cervical ultrasound.
• 8. Obesity as defined by body mass index (BMI) of 40 or greater.
• 9. History of previous spontaneous singleton delivery prior to 37 weeks.
• 10. Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.
• 11. Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.
• 12. Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.
• 13. Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.
• 14. Other maternal medical condition which is a contraindication to surgery or anesthesia.
• 15. Patient does not have a support person (e.g., husband, partner, parents).
• 16. Inability to comply with the travel and follow-up requirements of the study.
• 17. Patient does not meet psychosocial criteria as determined by the social worker evaluation.
• 18. Participation in another intervention study that influences maternal and fetal morbidity and mortality.
• 19. Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
• 20. Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.
• 21. Nickel allergy.
• 22. Maternal request to undergo open fetal surgery for the antenatal correction of OSB at our institution primarily or after failed fetoscopic approach.
• 23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.