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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02390895
Other study ID # P141202
Secondary ID 2014-A01948-39
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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