Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fetoscopic repair of spina bifida | Experimental | This is a single arm study, all patients will receive a fetoscopic repair of the spina bifida |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopic repair of spina bifida | Procedure | Fetoscopic intrauterine repair of open spina bifida |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time (minutes) | Time between the skin opening and skin closure | Time of procedure (day 0) |
| Fetoscopy time (minutes) | Time between the introduction of the first cannula and the removal of the last cannula |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative hemoglobin (g/dL) | Hemoglobin level after the procedure | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Carreras, PhD | Contact | ecarreras@vhebron.net | ||
| Nerea Maiz, PhD | Contact | nmaiz@vhebron.net |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27997256 | Background | 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. | |
| 28277363 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time of procedure (day 0) |
| Hospital stay (days) | Time between hospital admission and discharge | Between procedure and delivery, up to 21 weeks |
| Between procedure and discharge, up to 21 weeks |
| Gestational age at delivery (weeks and days as x/7) | Gestational age at birth | At birth, up to 21 weeks after procedure |
| Surgery to delivery interval (days) | Interval between surgery and birth | 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 | 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 | 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 | Between the procedure and birth, up to 21 weeks after procedure |
| Placental abruption (yes/no) | Binary variable describing the presence of a placental abruption | 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 | 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 | 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. | 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 | 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 | 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 | 1 month of life |
| Ventriculoperitoneal shunting (yes/no) | Binary variable describing the need of a ventriculoperitoneal shunting | Between birth and 12 months |
| 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. |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D016137 | Spina Bifida Cystica |
| D008591 | Meningomyelocele |
| D005315 | Fetal Diseases |
| D006849 | Hydrocephalus |
| D001139 | Arnold-Chiari Malformation |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016135 | Spinal Dysraphism |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided