NCT03856034 Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
| NCT ID | NCT03856034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | USFetus |
| Condition | Neural Tube Defects |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2018-11-02 |
| Primary Completion | 2020-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2018-11-02 with a primary completion date of 2020-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.
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.
Contact & Investigator
Ruben Quintero, MD
PRINCIPAL INVESTIGATOR
Wellington Regional Medical Center
Frequently Asked Questions
Who can join the NCT03856034 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Neural Tube Defects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03856034 currently recruiting?
Yes, NCT03856034 is actively recruiting participants. Contact the research team at q@the-fetal-institute.com for enrollment information.
Where is the NCT03856034 trial being conducted?
This trial is being conducted at Los Angeles, United States, Wellington, United States.
Who is sponsoring the NCT03856034 clinical trial?
NCT03856034 is sponsored by USFetus. The principal investigator is Ruben Quintero, MD at Wellington Regional Medical Center. The trial plans to enroll 12 participants.