Prenatal Endoscopic Repair of Fetal Spina Bifida

Myelomeningocele Clinical Trial

— ENDOSPIN  

Official title:

Prenatal Endoscopic Repair of Fetal Spina Bifida

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390895
• Other study ID #: P141202
• Secondary ID: 2014-A01948-39
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: July 6, 2022

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 6, 2022
• Est. primary completion date: July 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meningomyelocele
• Myelomeningocele
• Spinal Dysraphism

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Neonatal surgery	Need for neonatal surgery	Day 0 (birth of neonates)
Primary	Arnold Chiari anomaly at birth	the existence of an Arnold Chiari anomaly at birth	Day 0 (birth of neonates)
Primary	Ventriculo-peritoneal shunt	Ventriculo-peritoneal shunt within the 6 months after birth	Within the 6 months after birth
Primary	Level of injury		Within the 6 months after birth
Primary	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
Primary	Motor lower limb improvement outcomes		Within the 6 months after birth
Primary	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	Neurological development	Composite criteria: Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter	Within the 12 months after birth