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Completed

NCT Number: NCT02390895

Prenatal Endoscopic Repair of Fetal Spina Bifida

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic repair of myelomeningocele before 26 SA

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

Primary outcomes

  1. Successful surgery

    Time frame: Before 26 gestational weeks

    Composite criteria:

    • dissection of the placode
    • primary coverage or use of a patch
    • 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 outcomes

  1. Neurological development

    Time frame: Within the 12 months after birth

    Composite criteria:

    Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: ENDOSPIN

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2015
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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