Trial record 2 of 6 for:    "Myelomeningocele"

Prenatal Surgical Repair of Fetal Myelomeningocele (PRIUM)

This study is not yet open for participant recruitment.
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01983345
First received: November 7, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Foetus With Myelomeningocele
Procedure: prenatal surgical repair of fetal myelomeningocele

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prenatal Surgical Repair of Fetal Myelomeningocele

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Arnold Chiari anomaly at birth [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    the existence of an Arnold Chiari anomaly at birth

  • Defect [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no surgery
Experimental: open surgical repair
open surgical repair of myelomeningocele before 26 SA
Procedure: prenatal surgical repair of fetal myelomeningocele
open surgical repair of myelomeningocele before 26 weeks gestational age

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient of majority age, with an assumption by health insurance, understanding and speaking French
  • A term between 19 and 25 +6 weeks gestational age
  • Single-Pregnancy
  • Normal fetal karyotype
  • Myelomeningocele with higher-level defect between S1 and T1
  • Placenta not low-inserted or not covering
  • Fault-isolated ultrasound reference

Exclusion Criteria:

  • Age under 18 years
  • Patient foreigner who understands not French
  • Multiple Pregnancy
  • Low Placenta inserted or covering
  • Severe kyphosis
  • Placental abruption
  • Fetal malformation unrelated to the existence of myelomeningocele (the existence of a malposition of one or both feet do not represent an exclusion criterion)
  • Increased risk of preterm birth: a history of preterm delivery before 37 weeks gestational age, cervical length <26 mm before 26 weeks gestational age
  • Bleeding active between 20 and 26 weeks gestational age
  • Maternal obesity with BMI> 35
  • History of uterine surgery involving the anterior surface of the uterus
  • Maternal contradiction in surgery or general anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01983345

Contacts
Contact: Jean-Marie Jouannic, PUPH 0033144735228 laurence.lecomte@nck.aphp.fr
Contact: Laurence Lecomte, PhD 0033158413545 laurence.lecomte@nck.aphp.fr

Locations
France
Hopital Armand Trousseau, APHP Not yet recruiting
Paris, France, 75012
Contact: Jean-Marie JOUANNIC, PUPH    0033144735228    jean-marie.jouannic@trs.aphp.fr   
Contact: Laurence lecomte, PhD    0033158413545    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Michel ZERAH, PUPH APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01983345     History of Changes
Other Study ID Numbers: 2013-A00385-40
Study First Received: November 7, 2013
Last Updated: November 7, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Myelomeningocele
Arnold Chiari malformation
Spina bifida

Additional relevant MeSH terms:
Meningomyelocele
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014