Status:
UNKNOWN
Fetal Endoscopic Surgery for Spina Bifida
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Neural Tube Defects
Spina Bifida, Open
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.
Detailed Description
Introduction: 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 neurodegen...
Eligibility Criteria
Inclusion
- Maternal age \> 18 years old
- 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
- Fetal anomalies non related to neural tube defect (NTD) including chromosomal abnormalities
- Body mass index \> 35 kg/m2
- Maternal disorders contraindicating surgery
- Genetic anomalies with poor prognosis
- Sever kyphosis (\>30º)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03315637
Start Date
January 1 2015
End Date
December 31 2024
Last Update
October 20 2017
Active Locations (1)
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1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035