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Fetal Endoscopic Surgery for Spina Bifida (FESSB)

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ClinicalTrials.gov Identifier: NCT03315637
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Neural Tube Defects Spina Bifida, Open Myelomeningocele Fetal Disease Hydrocephalus Chiari Malformation Type 2 Congenital Abnormality Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus Procedure: Fetoscopic repair of spina bifida

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fetal Endoscopic Surgery for Spina Bifida
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024


Arms and Interventions

Arm Intervention/treatment
Experimental: Fetoscopic repair of spina bifida
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


Outcome Measures

Primary Outcome Measures :
  1. Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no) [ Time Frame: Time of procedure (day 0) ]
    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


Secondary Outcome Measures :
  1. Operating time (minutes) [ Time Frame: Time of procedure (day 0) ]
    Time between the skin opening and skin closure

  2. Fetoscopy time (minutes) [ Time Frame: Time of procedure (day 0) ]
    Time between the introduction of the first cannula and the removal of the last cannula

  3. Hospital stay (days) [ Time Frame: Between procedure and delivery, up to 21 weeks ]
    Time between hospital admission and discharge


Other Outcome Measures:
  1. Post-operative hemoglobin (g/dL) [ Time Frame: 24 hours after procedure ]
    Hemoglobin level after the procedure

  2. Blood transfusion (yes/no) [ Time Frame: Between procedure and discharge, up to 21 weeks ]
    Binary variable describing if a transfusion of blood derivates is carried out between the time of procedure and discharge

  3. Gestational age at delivery (weeks and days as x/7) [ Time Frame: At birth, up to 21 weeks after procedure ]
    Gestational age at birth

  4. Surgery to delivery interval (days) [ Time Frame: At birth, up to 21 weeks after procedure ]
    Interval between surgery and birth

  5. Premature rupture of membranes (PROM) (yes/no) [ Time Frame: Between the procedure and 37 weeks of pregnancy (18 weeks after procedure) ]
    Binary variable describing amniotic fluid leakage before the onset of labor

  6. Chorioamnionitis (yes/no) [ Time Frame: Between the procedure and birth, up to 21 weeks after procedure ]
    Binary variable describing the presence of a chorioamnionitis between the procedure and birth

  7. Oligohydramnios without PROM (yes/no) [ Time Frame: Between the procedure and birth, up to 21 weeks after procedure ]
    Binary variable describing the presence of a oligohydramnios (deepest pool < 2 cm) without evidence of vaginal amniotic fluid leakage

  8. Placental abruption (yes/no) [ Time Frame: Between the procedure and birth, up to 21 weeks after procedure ]
    Binary variable describing the presence of a placental abruption

  9. Mode of delivery (vaginal / cesarean) [ Time Frame: At birth, up to 21 weeks after procedure ]
    Binary variable describing the mode of delivery, vaginal or cesarean section

  10. Uterine dehiscence (yes/no) [ Time Frame: At birth, up to 21 weeks after procedure ]
    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

  11. Acute Pulmonary edema (yes/no) [ Time Frame: Between the procedure and birth, up to 21 weeks after procedure ]
    Binary variable describing the presence of a maternal pulmonary edema, regardless of the severity, between the procedure and discharge.

  12. Closure of the spinal defect (yes/no) [ Time Frame: Between birth and 1 month of life ]
    Binary variable describing the watertight closure of the defect

  13. Maintenance of the neurological level (Better / same / worse) [ Time Frame: 1 month of life ]
    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

  14. Reversal of Chiari malformation(completely reversed / mild improvement / no improvement) by MRI [ Time Frame: 1 month of life ]
    Categorical variable comparing the postnatal and prenatal MRI assessment of the Chiari malformation

  15. Ventriculoperitoneal shunting (yes/no) [ Time Frame: Between birth and 12 months ]
    Binary variable describing the need of a ventriculoperitoneal shunting


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315637


Contacts
Contact: Elena Carreras, PhD ecarreras@vhebron.net
Contact: Nerea Maiz, PhD nmaiz@vhebron.net

Locations
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Elena Carreras, PhD       ecarreras@vhebron.net   
Contact: Nerea Maiz, PhD       nmaiz@vhebron.net   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
More Information

Publications:
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03315637     History of Changes
Other Study ID Numbers: PR(AMI)152/2015
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Congenital Abnormalities
Hydrocephalus
Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Arnold-Chiari Malformation
Fetal Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nervous System Malformations
Pregnancy Complications