Prenatal Endoscopic Repair of Fetal Spina Bifida

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Prenatal Endoscopic Repair of Fetal Spina Bifida

Conditions
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Myelomeningocele

Intervention / Treatment
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* Procedure: endoscopic repair of myelomeningocele before 26 SA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient > 18 years old, with an assumption by health insurance, understanding and speaking French A term < or = 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally-invasive endoscopic repair<br>endoscopic repair of myelomeningocele before 26 SA | Procedure: endoscopic repair of myelomeningocele before 26 SA<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful surgery | Composite criteria: dissection of the placode primary coverage or use of a patch using only endoscopy with two trocars | Before 26 gestational weeks | 
| Neonatal surgery | Need for neonatal surgery | Day 0 (birth of neonates) | 
| Arnold Chiari anomaly at birth | the existence of an Arnold Chiari anomaly at birth | Day 0 (birth of neonates) | 
| Ventriculo-peritoneal shunt | Ventriculo-peritoneal shunt within the 6 months after birth | Within the 6 months after birth | 
| Level of injury |  | Within the 6 months after birth | 
| Foetal morbidity | Composite criteria: Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events | From surgery to delivery | 
| Motor lower limb improvement outcomes |  | Within the 6 months after birth | 
| Maternal morbidity | Composite criteria: Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events | From surgery to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological development | Composite criteria: Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter | Within the 12 months after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally-invasive endoscopic repair, fetal surgery, outcome, Foetus