Fetal Endoscopic Surgery for Spina Bifida

Hydrocephalus Clinical Trial

— FESSB  

Official title:

Fetal Endoscopic Surgery for Spina Bifida

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03315637
• Other study ID #: PR(AMI)152/2015
• 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
• 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 (>30º)

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation Type 2
• Congenital Abnormalities
• Congenital Abnormality
• Fetal Disease
• Hydrocephalus
• Meningomyelocele
• Myelomeningocele
• Neural Tube Defects
• Spina Bifida, Open
• Spinal Dysraphism
• Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus

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