In-Utero Endoscopic Correction of Spina Bifida

  • STATUS
    Recruiting
  • End date
    Dec 31, 2029
  • participants needed
    33
  • sponsor
    University of Southern California
Updated on 29 May 2022
myelomeningocele
fetal spina bifida
Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.

Details
Condition Neural Tube Defects, Spina Bifida, Myelomeningocele
Treatment In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique, In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique
Clinical Study IdentifierNCT04362592
SponsorUniversity of Southern California
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography
Maternal age ≥18 years
Gestational age of 19 to 27 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound
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
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
Positive evaluation from pediatric neurology consult
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

Exclusion Criteria

Multiple gestation
Insulin-dependent pregestational diabetes
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
Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI
Presence of uterine cervical cerclage or history of incompetent cervix
Placenta previa or placental abruption
Short cervix < 25 mm measured by cervical ultrasound
Obesity as defined by body mass index (BMI) of 40 or greater
History of previous spontaneous singleton delivery prior to 37 weeks
Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia
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
Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened
Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality
Other maternal medical condition which is a contraindication to surgery or anesthesia
Patient does not have a support person (e.g., husband, partner, parents)
Inability to comply with the travel and follow-up requirements of the study
Patient does not meet psychosocial criteria as determined by the social worker evaluation
Participation in another intervention study that influences maternal and fetal morbidity and mortality
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)
Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery
Nickel allergy
Maternal request to undergo open fetal surgery for the antenatal correction of OSB at our institution primarily or after failed fetoscopic approach
Known maternal hypersensitivity to bovine collagen or chondroitin materials
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