Hydrocephalus Clinical Trial
— FESSBOfficial title:
Fetal Endoscopic Surgery for Spina Bifida
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 (>30ยบ) |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Vall d'Hebron | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute |
Spain,
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. — View Citation
Maroto A, Illescas T, Meléndez M, Arévalo S, Rodó C, Peiró 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Post-operative hemoglobin (g/dL) | Hemoglobin level after the procedure | 24 hours after procedure | |
Other | Blood transfusion (yes/no) | Binary variable describing if a transfusion of blood derivates is carried out between the time of procedure and discharge | Between procedure and discharge, up to 21 weeks | |
Other | Gestational age at delivery (weeks and days as x/7) | Gestational age at birth | At birth, up to 21 weeks after procedure | |
Other | Surgery to delivery interval (days) | Interval between surgery and birth | At birth, up to 21 weeks after procedure | |
Other | Premature rupture of membranes (PROM) (yes/no) | Binary variable describing amniotic fluid leakage before the onset of labor | Between the procedure and 37 weeks of pregnancy (18 weeks after procedure) | |
Other | Chorioamnionitis (yes/no) | Binary variable describing the presence of a chorioamnionitis between the procedure and birth | Between the procedure and birth, up to 21 weeks after procedure | |
Other | Oligohydramnios without PROM (yes/no) | Binary variable describing the presence of a oligohydramnios (deepest pool < 2 cm) without evidence of vaginal amniotic fluid leakage | Between the procedure and birth, up to 21 weeks after procedure | |
Other | Placental abruption (yes/no) | Binary variable describing the presence of a placental abruption | Between the procedure and birth, up to 21 weeks after procedure | |
Other | Mode of delivery (vaginal / cesarean) | Binary variable describing the mode of delivery, vaginal or cesarean section | At birth, up to 21 weeks after procedure | |
Other | Uterine dehiscence (yes/no) | Binary variable describing the presence of a uterine dehiscence, regardless of whether it is symptomatic or it is diagnosed at the time of cesarean section | At birth, up to 21 weeks after procedure | |
Other | Acute Pulmonary edema (yes/no) | Binary variable describing the presence of a maternal pulmonary edema, regardless of the severity, between the procedure and discharge. | Between the procedure and birth, up to 21 weeks after procedure | |
Other | Closure of the spinal defect (yes/no) | Binary variable describing the watertight closure of the defect | Between birth and 1 month of life | |
Other | Maintenance of the neurological level (Better / same / worse) | Categorical variable describing if the postnatally assessed neurological level is better / same or worse than the level assessed prenatally before the procedure. It will be assessed by physical examination | 1 month of life | |
Other | Reversal of Chiari malformation(completely reversed / mild improvement / no improvement) by MRI | Categorical variable comparing the postnatal and prenatal MRI assessment of the Chiari malformation | 1 month of life | |
Other | Ventriculoperitoneal shunting (yes/no) | Binary variable describing the need of a ventriculoperitoneal shunting | Between birth and 12 months | |
Primary | Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no) | Binary variable (yes/no) describing if the neural tube defect has been successfully closed, (placode dissected and dropped into the open spinal canal, cystic tissue resected and edges closed to the midline), by fetoscopic surgery, and without conversion to open surgery | Time of procedure (day 0) | |
Secondary | Operating time (minutes) | Time between the skin opening and skin closure | Time of procedure (day 0) | |
Secondary | Fetoscopy time (minutes) | Time between the introduction of the first cannula and the removal of the last cannula | Time of procedure (day 0) | |
Secondary | Hospital stay (days) | Time between hospital admission and discharge | Between procedure and delivery, up to 21 weeks |
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