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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03315637
Other study ID # PR(AMI)152/2015
Secondary ID
Status Recruiting
Phase N/A
First received October 3, 2017
Last updated October 16, 2017
Start date January 2015
Est. completion date December 31, 2024

Study information

Verified date October 2017
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Elena Carreras, PhD
Email ecarreras@vhebron.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Intervention

Procedure:
Fetoscopic repair of spina bifida
Fetoscopic intrauterine repair of open spina bifida

Locations

Country Name City State
Spain Hospital Universitari Vall d'Hebron Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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

Outcome

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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