Prenatal Endoscopic Repair of Fetal Spina Bifida

Not Applicable

Completed

• Conditions: Myelomeningocele
• Interventions: Procedure: endoscopic repair of myelomeningocele before 26 SA

• Registration Number: NCT02390895
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2015-02-15
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-18
• Study Start: 2017-05-17
• Primary Completion: 2022-07-06
• Study Completion: 2022-07-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally-invasive endoscopic repair	endoscopic repair of myelomeningocele before 26 SA	endoscopic repair of myelomeningocele before 26 SA

Primary Outcome Measures

Name	Time	Method
Successful surgery	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
Motor lower limb improvement outcomes	Within the 6 months after birth
Maternal morbidity	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
Neonatal surgery	Day 0 (birth of neonates)	Need for neonatal surgery
Arnold Chiari anomaly at birth	Day 0 (birth of neonates)	the existence of an Arnold Chiari anomaly at birth
Ventriculo-peritoneal shunt	Within the 6 months after birth	Ventriculo-peritoneal shunt within the 6 months after birth
Level of injury	Within the 6 months after birth
Foetal morbidity	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

Name	Time	Method
Neurological development	Within the 12 months after birth	Composite criteria: Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France