Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

Inclusion 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 25 6/7 weeks' gestation as determined by clinical information
and evaluation of first ultrasound.

4. Balanced karyotype 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 remain in the greater Wellington or Pasadena area (within a 30-minute car
ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center
or Huntington Memorial Hospital for postnatal management. The participants must be
willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up
evaluation.

Exclusion Criteria:

1. Multiple gestation

2. Insulin-dependent pregestational diabetes

3. Presence of a fetal anomaly not related to myelomeningocele. 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 35 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 open
spina bifida at our institution primarily or after failed fetoscopic approach.

23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.