Prenatal Endoscopic Repair of Fetal Spina Bifida

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2022-07-06

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Myelomeningocele

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minimally-invasive endoscopic repair

endoscopic repair of myelomeningocele before 26 SA

Group Type EXPERIMENTAL

endoscopic repair of myelomeningocele before 26 SA

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No