An interventional study of Fetoscopic repair of spina bifida in Neural Tube Defects, Spina Bifida, Open and Myelomeningocele, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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.
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 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.
47 studies on the registry are indexed under Neural Tube Defects; 9 are open to participants now.
This study's planned enrollment of 50 is close to the median of 47 across 26 interventional studies indexed under Neural Tube Defects.
Browse Neural Tube Defects studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a single arm study, all patients will receive a fetoscopic repair of the spina bifida
Procedure: Fetoscopic repair of spina bifida
Fetoscopic intrauterine repair of open spina bifida
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 frame: Time of procedure (day 0)
Operating time (minutes)
Time between the skin opening and skin closure
Time frame: Time of procedure (day 0)
Fetoscopy time (minutes)
Time between the introduction of the first cannula and the removal of the last cannula
Time frame: Time of procedure (day 0)
Hospital stay (days)
Time between hospital admission and discharge
Time frame: Between procedure and delivery, up to 21 weeks
Post-operative hemoglobin (g/dL)
Hemoglobin level after the procedure
Time frame: 24 hours after procedure
Blood transfusion (yes/no)
Binary variable describing if a transfusion of blood derivates is carried out between the time of procedure and discharge
Time frame: Between procedure and discharge, up to 21 weeks
Gestational age at delivery (weeks and days as x/7)
Gestational age at birth
Time frame: At birth, up to 21 weeks after procedure
Surgery to delivery interval (days)
Interval between surgery and birth
Time frame: At birth, up to 21 weeks after procedure
Premature rupture of membranes (PROM) (yes/no)
Binary variable describing amniotic fluid leakage before the onset of labor
Time frame: Between the procedure and 37 weeks of pregnancy (18 weeks after procedure)
Chorioamnionitis (yes/no)
Binary variable describing the presence of a chorioamnionitis between the procedure and birth
Time frame: Between the procedure and birth, up to 21 weeks after procedure
Oligohydramnios without PROM (yes/no)
Binary variable describing the presence of a oligohydramnios (deepest pool \< 2 cm) without evidence of vaginal amniotic fluid leakage
Time frame: Between the procedure and birth, up to 21 weeks after procedure
Placental abruption (yes/no)
Binary variable describing the presence of a placental abruption
Time frame: Between the procedure and birth, up to 21 weeks after procedure
Mode of delivery (vaginal / cesarean)
Binary variable describing the mode of delivery, vaginal or cesarean section
Time frame: At birth, up to 21 weeks after procedure
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
Time frame: At birth, up to 21 weeks after procedure
Acute Pulmonary edema (yes/no)
Binary variable describing the presence of a maternal pulmonary edema, regardless of the severity, between the procedure and discharge.
Time frame: Between the procedure and birth, up to 21 weeks after procedure
Closure of the spinal defect (yes/no)
Binary variable describing the watertight closure of the defect
Time frame: Between birth and 1 month of life
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
Time frame: 1 month of life
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
Time frame: 1 month of life
Ventriculoperitoneal shunting (yes/no)
Binary variable describing the need of a ventriculoperitoneal shunting
Time frame: Between birth and 12 months
Started Jan 2015 (actual). Primary completion is estimated for Dec 2021, 83 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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