Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2015-01-31
2024-12-31
Brief Summary
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Detailed Description
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Spina bifida is a congenital malformation characterized by a failure in neural tube closure. Unprotected fetal neural tissue at the spine level undergoes not only progressive neurodegeneration in spinal cord, but also the impairment in brain development, hindbrain herniation or Chiari II malformation probably due to pressure disturbances resulting from a continuous leakage of cerebrospinal fluid through the defect. The neurological consequences at birth are irreversible and sometimes devastating, including paraplegia, sphincter urinary and fecal incontinence, hydrocephalus, cranial nerve disturbances, respiratory problems and death due to spinal cord injury and brain maldevelopment.
Intrauterine fetal open repair of the defect has proved to improve hindbrain herniation and decrease the need of cerebrospinal shunting.
Hypothesis:
The investigators hypothesize that minimally invasive surgery of spina bifida is feasible and may minimize surgical aggression and obstetrical complications, with similar neonatal and neurological results.
Intervention:
In this study the investigators propose a fetoscopic skin closure technique. After a maternal laparotomy the uterus is exteriorized, the amniotic cavity is accessed by fetoscopic approach. The placode is dissected from the surrounding tissue and dropped into the opened spinal canal, untethered. Part of the cystic tissue is resected. The edges are then closed to the midline.
Follow up:
After surgery patients are followed up at the Fetal Medicine Unit every one or two weeks.
The mode of delivery is decided according to obstetric criteria. Neonates will be examined at birth, and followed up regularly at least until 30 months. Patients are lifetime followed up by our Multidisciplinary myelomeningocele (MMC) Committee that comprises professionals from the Spina Bifida Unit, Neonatologists, Pediatric Surgeons, Pediatric Urologist, Pediatric Orthopedic Surgeons, Radiologists, Rehabilitation, Pathologists, Pediatric Neurosurgeons, Obstetricians and Fetal Therapists.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fetoscopic repair of spina bifida
This is a single arm study, all patients will receive a fetoscopic repair of the spina bifida
Fetoscopic repair of spina bifida
Fetoscopic intrauterine repair of open spina bifida
Interventions
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Fetoscopic repair of spina bifida
Fetoscopic intrauterine repair of open spina bifida
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Gestational age between 18 0/7 weeks and 26 6/7 weeks
* Isolated neural tube defect between T1 and S1
* Cerebellar herniation (Chiari type II)
Exclusion Criteria
* Body mass index \> 35 kg/m2
* Maternal disorders contraindicating surgery
* Genetic anomalies with poor prognosis
* Sever kyphosis (\>30ยบ)
18 Years
50 Years
FEMALE
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Elena Carreras, PhD
Role: primary
Nerea Maiz, PhD
Role: backup
References
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Maroto A, Illescas T, Melendez M, Arevalo S, Rodo C, Peiro JL, Belfort M, Cuxart A, Carreras E. Ultrasound functional evaluation of fetuses with myelomeningocele: study of the interpretation of results. J Matern Fetal Neonatal Med. 2017 Oct;30(19):2301-2305. doi: 10.1080/14767058.2016.1247262. Epub 2017 Jan 16.
Belfort MA, Whitehead WE, Shamshirsaz AA, Bateni ZH, Olutoye OO, Olutoye OA, Mann DG, Espinoza J, Williams E, Lee TC, Keswani SG, Ayres N, Cassady CI, Mehollin-Ray AR, Sanz Cortes M, Carreras E, Peiro JL, Ruano R, Cass DL. Fetoscopic Open Neural Tube Defect Repair: Development and Refinement of a Two-Port, Carbon Dioxide Insufflation Technique. Obstet Gynecol. 2017 Apr;129(4):734-743. doi: 10.1097/AOG.0000000000001941.
Other Identifiers
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PR(AMI)152/2015
Identifier Type: -
Identifier Source: org_study_id