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Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03856034
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
Wellington Hospital
University of Southern California
Information provided by (Responsible Party):
USFetus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neural Tube Defects Spina Bifida Myelomeningocele Chiari Malformation Device: Fetoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study
Actual Study Start Date : November 2, 2018
Estimated Primary Completion Date : November 2, 2020
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fetoscopic repair Device: Fetoscopy
Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).


Outcome Measures
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Primary Outcome Measures :
  1. Rate of successful in-utero fetoscopic myelomeningocele closures using either laparotomy or percutaneous techniques [ Time Frame: At time of surgery until delivery, up to 21 weeks ]
    Successful fetoscopic closure of the spinal defect and reversal of hindbrain herniation as assessed by ultrasound and MRI prior to delivery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856034


Contacts
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Contact: Ruben Quintero, MD 720-753-3825 q@the-fetal-institute.com
Contact: Ramen Chmait, MD 626-356-3360 chmait@usc.edu

Locations
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United States, California
University of Southern California / Huntington Memorial Hospital Recruiting
Los Angeles, California, United States, 91105
Contact: Ramen Chmait, MD    626-356-3360    chmait@usc.edu   
Contact: Arlyn Llanes, RN    626-356-3360    arlyn.llanes@med.usc.edu   
United States, Florida
Wellington Regional Medical Center Recruiting
Wellington, Florida, United States, 33141
Contact: Ruben Quintero, MD    720-753-3825    q@the-fetal-institute.com   
Contact: Eftichia Kontopoulos, MD    720-753-3825    k@the-fetal-institute.com   
Sponsors and Collaborators
USFetus
Wellington Hospital
University of Southern California
Investigators
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Principal Investigator: Ruben Quintero, MD Wellington Regional Medical Center
Principal Investigator: Ramen Chmait, MD University of Southern California/ Huntington Memorial Hospital
More Information
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Responsible Party: USFetus
ClinicalTrials.gov Identifier: NCT03856034    
Other Study ID Numbers: 1249628
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by USFetus:
spina bifida
myelomeningocele
neural tube defect
chiari malformation
 fetoscopy
percutaneous
fetus
Additional relevant MeSH terms:
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Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
 Arnold-Chiari Malformation
Congenital Abnormalities
Nervous System Malformations
Nervous System Diseases