Prenatal Endoscopic Repair of Fetal Spina Bifida

NCT02390895 | Completed DMC

• 2 other identifiers: P1412022014-A01948-39
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Myelomeningocele

Keywords

Minimally-invasive endoscopic repair; fetal surgery; outcome; Foetus

Outcome Measures

Primary Outcomes (8)

• Successful surgery

  Composite criteria: 1. dissection of the placode 2. primary coverage or use of a patch 3. 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 Outcomes (1)

• Neurological development

  Within the 12 months after birth

Study Arms (1)

Minimally-invasive endoscopic repair

EXPERIMENTAL

endoscopic repair of myelomeningocele before 26 SA

Procedure: endoscopic repair of myelomeningocele before 26 SA

Interventions

endoscopic repair of myelomeningocele before 26 SA PROCEDURE

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

Minimally-invasive endoscopic repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (5)

• Arthuis C, James S, Bussieres L, Hovhannisyan S, Corroenne R, Ville Y, Stirnemann JJ. Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France. Fetal Diagn Ther. 2022;49(9-10):377-384. doi: 10.1159/000525552. Epub 2022 Aug 31.

  PMID: 36044834 BACKGROUND

• Kohl T. Percutaneous minimally invasive fetoscopic surgery for spina bifida aperta. Part I: surgical technique and perioperative outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):515-24. doi: 10.1002/uog.13430.

  PMID: 24891102 BACKGROUND

• Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.

  PMID: 21306277 BACKGROUND

• Degenhardt J, Schurg R, Winarno A, Oehmke F, Khaleeva A, Kawecki A, Enzensberger C, Tinneberg HR, Faas D, Ehrhardt H, Axt-Fliedner R, Kohl T. Percutaneous minimal-access fetoscopic surgery for spina bifida aperta. Part II: maternal management and outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):525-31. doi: 10.1002/uog.13389.

  PMID: 24753062 BACKGROUND

• Verbeek RJ, Heep A, Maurits NM, Cremer R, Hoving EW, Brouwer OF, van der Hoeven JH, Sival DA. Fetal endoscopic myelomeningocele closure preserves segmental neurological function. Dev Med Child Neurol. 2012 Jan;54(1):15-22. doi: 10.1111/j.1469-8749.2011.04148.x. Epub 2011 Nov 29.

  PMID: 22126123 BACKGROUND

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yves Ville, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Julien Stirnemann, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2015
• First Posted: March 18, 2015
• Study Start: May 17, 2017
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)