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Prenatal Surgical Repair of Fetal Myelomeningocele (PRIUM)

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ClinicalTrials.gov Identifier: NCT01983345
Recruitment Status : Recruiting
First Posted : November 14, 2013
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Foetus With Myelomeningocele Procedure: prenatal surgical repair of fetal myelomeningocele Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prenatal Surgical Repair of Fetal Myelomeningocele
Actual Study Start Date : July 10, 2014
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
No Intervention: Control
No prenatal surgical repair of myelomeningocele
Experimental: Case - open surgical repair
Prenatal surgical repair of fetal myelomeningocele
Procedure: prenatal surgical repair of fetal myelomeningocele
open surgical repair of myelomeningocele before 26 weeks gestational age




Primary Outcome Measures :
  1. Arnold Chiari anomaly at birth [ Time Frame: Day 0 ]
    the existence of an Arnold Chiari anomaly at birth

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 (not for control)
  • 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 (not for control)
  • Bleeding active between 20 and 26 weeks gestational age (not for control)
  • Maternal obesity with BMI> 35 (not for control)
  • History of uterine surgery involving the anterior surface of the uterus (not for control)
  • Maternal contradiction in surgery or general anesthesia (not for control)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983345


Contacts
Contact: Jean-Marie Jouannic, MD, PhD 0033144735228 laurence.lecomte@nck.aphp.fr
Contact: Nelly Briand, PhD 0033144381862 nelly.briand@aphp.fr

Locations
France
Hopital Armand Trousseau, APHP Recruiting
Paris, France, 75012
Contact: Jean-Marie JOUANNIC, PUPH    0033144735228    jean-marie.jouannic@trs.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Michel Zerah, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Jean-Marie Jouannic, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01983345     History of Changes
Other Study ID Numbers: P121103
2013-A00385-40 ( Registry Identifier: ID-RCB )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Spinal Dysraphism