Comparing two surgical methods for correcting fetal myelomeningocele

In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study

This study is testing two different surgical methods to see which one works better and is safer for fixing a serious birth defect called fetal myelomeningocele before the baby is born.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: USFetus (Academic / other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT03856034 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of a fetoscopic surgical technique for the antenatal correction of fetal myelomeningocele, a type of neural tube defect. Participants will be assigned to one of two surgical approaches: a percutaneous method for those with a posterior placenta and a laparotomy/uterine exteriorization method for all participants regardless of placental location. The study aims to determine the effectiveness and safety of these interventions in improving outcomes for affected fetuses. The surgical techniques will be assessed based on their feasibility and potential benefits.

Who should consider this trial

Good fit: Ideal candidates include pregnant women aged 18 or older with a diagnosis of myelomeningocele at specific spinal levels and hindbrain herniation, within the appropriate gestational age.

Not a fit: Patients with myelomeningocele outside the specified levels or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical options for correcting myelomeningocele before birth, potentially enhancing neurological outcomes for affected infants.

How similar studies have performed: Other studies have explored similar surgical techniques for myelomeningocele, showing promising results, but this specific approach is still being evaluated for its feasibility.

Eligibility criteria

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 27 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.

Where this trial is running

Los Angeles, California and 1 other locations

• University of Southern California / Huntington Memorial Hospital — Los Angeles, California, United States (Recruiting)
• Wellington Regional Medical Center — Wellington, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Ruben Quintero, MD — Wellington Regional Medical Center
• Study coordinator: Ruben Quintero, MD

Conditions Neural Tube Defects; Spina Bifida; Myelomeningocele; Chiari Malformation; spina bifida; myelomeningocele; neural tube defect; chiari malformation