Clinical trial NCT02390895: Prenatal Endoscopic Repair of Fetal Spina Bifida
Official title: Prenatal Endoscopic Repair of Fetal Spina Bifida
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelomeningocele
Keywords: Minimally-invasive endoscopic repair
fetal surgery
outcome
Foetus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Successful surgery
timeFrame: Before 26 gestational weeks
measure: Neonatal surgery
timeFrame: Day 0 (birth of neonates)
measure: Arnold Chiari anomaly at birth
timeFrame: Day 0 (birth of neonates)
measure: Ventriculo-peritoneal shunt
timeFrame: Within the 6 months after birth
measure: Level of injury
timeFrame: Within the 6 months after birth
measure: Foetal morbidity
timeFrame: From surgery to delivery
measure: Motor lower limb improvement outcomes
timeFrame: Within the 6 months after birth
measure: Maternal morbidity
timeFrame: From surgery to delivery
Secondary outcomes:
measure: Neurological development
timeFrame: Within the 12 months after birth
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yves Ville, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Julien Stirnemann, MD, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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: 10.1159/000525552. Epub 2022 Aug 31.