Clinical Trial: Prenatal Surgical Repair of Fetal Myelomeningocele

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prenatal Surgical Repair of Fetal Myelomeningocele

Brief Summary:

The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥ 10 mm), and get a lower of injury than one corresponding to the anatomical defect (as defined by the last upper normal vertebra before the defect).

The purpose of this study is to introduce in France an innovative technique for prenatal repair of myelomeningocele until now developed only on the American continent.


Detailed Summary:

Spina bifida (SB) represents one of the most severe congenital malformation of the central nervous system and amenable to prenatal diagnosis. In the past 20 years, prenatal repair of SB has become an established technique.

The PRIUM study will include 10 cases of fetuses with prenatal diagnosis of SB and for whom the maternal willing will be to continue the pregnancy. A surgical prenatal repair of the defect will be planed at 19-25+6 weeks gestation following maternal laparotomy and hysterotomy under maternal general anesthesia. The delivery will be planed at 36 weeks'. Postnatal evaluation of the neonates will be scheduled at birth, 1 month and 12 months od age. Those data will be matched to controls who have underwent a conventional postnatal repair of the SB


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome:

  • Arnold Chiari anomaly at birth [ Time Frame: Day 0 ]
    the existence of an Arnold Chiari anomaly at birth
  • Defect [ Time Frame: 3 years ]
    the level difference between the observed level of injury and the anatomical level of the defect (as defined by the last normal upper vertebra before the defect)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: November 7, 2013
Date Started: July 2014
Date Completion: September 2019
Last Updated: July 31, 2016
Last Verified: July 2016