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Prenatal Endoscopic Repair of Fetal Spina Bifida (ENDOSPIN)

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ClinicalTrials.gov Identifier: NCT02390895
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

Condition or disease Intervention/treatment Phase
Myelomeningocele Procedure: endoscopic repair of myelomeningocele before 26 SA Procedure: Postnatal Myelomeningocele Repair Surgery Not Applicable

Detailed Description:

Compared with an open approach involving laparotomy and hysterotomy, an endoscopic approach for the prenatal surgery of myelomeningocele offers at least two potential advantages: i) it may reduce the maternal and obstetric morbidity related to the hysterotomy; ii) it may be performed earlier in gestation than open surgery, therefore potentially further reducing exposition of the spinal chord to the intraamniotic environment and thus improving the overall prognosis of the malformation. This study aims to evaluate the feasibility and potential benefits of a minimally invasive endoscopic procedure for the prenatal treatment of myelomeningocele in a single-center trial.

Technically the procedure will be performed through 2 intra-amniotic ports, under fetoscopic visualization and intra-amniotic carbon dioxide insufflation. The defect will be dissected and the cord replaced in the canal. Closure will be performed by suturing paravertebral muscles using a barbed running suture. A Duragen patch will be sutured when primary closure is deemed impossible.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prenatal Endoscopic Repair of Fetal Spina Bifida
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 16, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minimally-invasive endoscopic repair
endoscopic repair of myelomeningocele before 26 SA
Procedure: endoscopic repair of myelomeningocele before 26 SA
prenatal minimally-invasive fetoscopic closure with iii) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation iv) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

surgery at birth
Non eligible pregnant women because of foetal or maternal reasons or women refusing the prenatal surgery
Procedure: Postnatal Myelomeningocele Repair Surgery
repair of myleomeningocele after birth




Primary Outcome Measures :
  1. successful surgery [ Time Frame: Before 26 gestational weeks ]

    Composite criteria:

    1. dissection of the placode
    2. primary coverage or use of a patch
    3. using only endoscopy with two trocars

  2. Neonatal surgery [ Time Frame: Day 0 (birth of neonates) ]
    Need for neonatal surgery

  3. Arnold Chiari anomaly at birth [ Time Frame: Day 0 (birth of neonates) ]
    the existence of an Arnold Chiari anomaly at birth

  4. Ventriculo-peritoneal shunt [ Time Frame: Within the 6 months after birth ]
    Ventriculo-peritoneal shunt within the 6 months after birth

  5. Level of injury [ Time Frame: Within the 6 months after birth ]
  6. Foetal [ Time Frame: From surgery to delivery ]

    Composite criteria:

    Stillbirth Premature Rupture of Membranes Preterm birth Chorioamnionitis Hemorrhagic complications during the peri-operative period Other serious adverse events


  7. motor lower limb improvement outcomes [ Time Frame: Within the 6 months after birth ]
  8. maternal morbidity [ Time Frame: From surgery to delivery ]

    Composite criteria:

    Stillbirth Premature Rupture of Membranes Preterm birth Chorioamnionitis Hemorrhagic complications during the peri-operative period Other serious adverse events



Secondary Outcome Measures :
  1. Neurological development [ Time Frame: 36 months ]

    Composite criteria:

    Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter


  2. WPPSI-III (Wechsler Preschool and Primary Scale of Intelligence) :evaluation of intellectual quotient [ Time Frame: 36 months ]
    Neurodevelopment outcome

  3. Brunet-Lezine Psychomotor Development Scale [ Time Frame: 36 months ]
    Psychomotor and Development outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient > 18 years old, with an assumption by health insurance, understanding and speaking French
  • A term before 26 +0 weeks gestational age
  • Single-Pregnancy
  • Myelomeningocele with higher-level defect between S1 and T1
  • Arnold Chiari anomaly
  • No associated anomaly or chromosic anomaly
  • Normal fetal karyotype or FISH

Exclusion Criteria:

  • severe foetal kyphoscoliosis associated
  • Increased risk of preterm birth: cervical length <15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane
  • placenta previa, accreta or placental abruption
  • Maternal obesity with BMI> 35
  • Uterine anomalies : large interstitial uterine fibroid, uterine malformation
  • maternal infection with a foetal transmission risk: HIV, HBV, HCV Maternal contradiction in surgery or anesthesia
  • poor social status and/or social isolation
  • impossible post-surgery follow-up
  • want to have a medical pregnancy termination

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): NCT02390895


Contacts
Contact: Yves Ville, PUPH 01 71 39 65 13 ville.yves@gmail.com
Contact: Nelly Briand, PhD +33 1 44 38 18 62 nelly.briand@nck.aphp.fr

Locations
France
Hôpital Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: Yves Ville, PUPH    01 71 39 65 13    ville.yves@gmail.com   
Contact: Laurence Lecomte, PhD    +33 1 71 19 64 94    laurence.lecomte@nck.aphp.fr   
Sub-Investigator: Julien STIRNEMANN, MD-PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves Ville, PUPH APHP

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02390895     History of Changes
Other Study ID Numbers: P141202
2014-A01948-39 ( Other Identifier: ANSM )
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Minimally-invasive endoscopic repair
fetal surgery
outcome
Foetus

Additional relevant MeSH terms:
Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities