Prenatal Endoscopic Repair of Fetal Spina Bifida (ENDOSPIN)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Myelomeningocele

Treatments

Procedure: endoscopic repair of myelomeningocele before 26 SA

Study type

Interventional

Funder types

Other

Identifiers

NCT02390895

2014-A01948-39 (Other Identifier)

P141202

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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