Prenatal Endoscopic Repair of Fetal Spina Bifida (ENDOSPIN)

• ClinicalTrials.gov Identifier: NCT02390895
• Recruitment Status: Completed
• First Posted: March 18, 2015
• Last Update Posted: October 12, 2022
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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

Condition or disease	Intervention/treatment	Phase
Myelomeningocele	Procedure: endoscopic repair of myelomeningocele before 26 SA	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prenatal Endoscopic Repair of Fetal Spina Bifida
• Actual Study Start Date: May 17, 2017
• Actual Primary Completion Date: July 6, 2022
• Actual Study Completion Date: July 6, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Minimally-invasive endoscopic repair; endoscopic repair of myelomeningocele before 26 SA	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

Outcome Measures

Primary Outcome Measures :

1. 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
2. Neonatal surgery [ Time Frame: Day 0 (birth of neonates) ]
   Need for neonatal surgery
3. Arnold Chiari anomaly at birth [ Time Frame: Day 0 (birth of neonates) ]
   the existence of an Arnold Chiari anomaly at birth
4. Ventriculo-peritoneal shunt [ Time Frame: Within the 6 months after birth ]
   Ventriculo-peritoneal shunt within the 6 months after birth
5. Level of injury [ Time Frame: Within the 6 months after birth ]
6. Foetal morbidity [ 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

7. Motor lower limb improvement outcomes [ Time Frame: Within the 6 months after birth ]
8. Maternal morbidity [ 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

Secondary Outcome Measures :

1. Neurological development [ Time Frame: Within the 12 months after birth ]

   Composite criteria:

   Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

Hôpital Necker Enfants Malades

Paris, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Yves Ville, MD, PhD; Assistance Publique - Hôpitaux de Paris
• Study Director: Julien Stirnemann, MD, PhD; Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02390895
• Other Study ID Numbers: P141202; 2014-A01948-39 ( Other Identifier: ANSM )
• First Posted: March 18, 2015
• Last Update Posted: October 12, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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

Additional relevant MeSH terms:

Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities