Clinical trial NCT03315637: Fetal Endoscopic Surgery for Spina Bifida
Official title: Fetal Endoscopic Surgery for Spina Bifida
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neural Tube Defects
Spina Bifida, Open
Myelomeningocele
Fetal Disease
Hydrocephalus
Chiari Malformation Type 2
Congenital Abnormality
Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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 (\>30º)

Primary outcomes:
measure: Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)
timeFrame: Time of procedure (day 0)
Secondary outcomes:
measure: Operating time (minutes)
timeFrame: Time of procedure (day 0)
measure: Fetoscopy time (minutes)
timeFrame: Time of procedure (day 0)
measure: Hospital stay (days)
timeFrame: Between procedure and delivery, up to 21 weeks
Other outcomes:
measure: Post-operative hemoglobin (g/dL)
timeFrame: 24 hours after procedure
measure: Blood transfusion (yes/no)
timeFrame: Between procedure and discharge, up to 21 weeks
measure: Gestational age at delivery (weeks and days as x/7)
timeFrame: At birth, up to 21 weeks after procedure
measure: Surgery to delivery interval (days)
timeFrame: At birth, up to 21 weeks after procedure
measure: Premature rupture of membranes (PROM) (yes/no)
timeFrame: Between the procedure and 37 weeks of pregnancy (18 weeks after procedure)
measure: Chorioamnionitis (yes/no)
timeFrame: Between the procedure and birth, up to 21 weeks after procedure
measure: Oligohydramnios without PROM (yes/no)
timeFrame: Between the procedure and birth, up to 21 weeks after procedure
measure: Placental abruption (yes/no)
timeFrame: Between the procedure and birth, up to 21 weeks after procedure
measure: Mode of delivery (vaginal / cesarean)
timeFrame: At birth, up to 21 weeks after procedure
measure: Uterine dehiscence (yes/no)
timeFrame: At birth, up to 21 weeks after procedure
measure: Acute Pulmonary edema (yes/no)
timeFrame: Between the procedure and birth, up to 21 weeks after procedure
measure: Closure of the spinal defect (yes/no)
timeFrame: Between birth and 1 month of life
measure: Maintenance of the neurological level (Better / same / worse)
timeFrame: 1 month of life
measure: Reversal of Chiari malformation(completely reversed / mild improvement / no improvement) by MRI
timeFrame: 1 month of life
measure: Ventriculoperitoneal shunting (yes/no)
timeFrame: Between birth and 12 months
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
References:
citation: 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.
citation: 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.