Clinical Trial: Prenatal Endoscopic Repair of Fetal Spina Bifida

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Prenatal Endoscopic Repair of Fetal Spina Bifida

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

Detailed Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome:

  • 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
  • Neonatal surgery [ Time Frame: Day 0 (birth of neonates) ]
    Need for neonatal surgery
  • Arnold Chiari anomaly at birth [ Time Frame: Day 0 (birth of neonates) ]
    the existence of an Arnold Chiari anomaly at birth
  • Ventriculo-peritoneal shunt [ Time Frame: Within the 6 months after birth ]
    Ventriculo-peritoneal shunt within the 6 months after birth
  • Level of injury [ Time Frame: Within the 6 months after birth ]
  • 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

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

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Neurological development [ Time Frame: 36 months ]

      Composite criteria:

      Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter

    • WPPSI-III (Wechsler Preschool and Primary Scale of Intelligence) :evaluation of intellectual quotient [ Time Frame: 36 months ]
      Neurodevelopment outcome
    • Brunet-Lezine Psychomotor Development Scale [ Time Frame: 36 months ]
      Psychomotor and Development outcome


    Original Secondary Outcome: Same as current

    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: February 15, 2015
    Date Started: October 2016
    Date Completion: September 2022
    Last Updated: July 31, 2016
    Last Verified: July 2016