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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 : August 2, 2016
Information provided by (Responsible Party):

Study Description
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
Foetus With Myelomeningocele Procedure: prenatal surgical repair of fetal myelomeningocele

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 Design

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
Study Start Date : July 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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)

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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

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

Hopital Armand Trousseau, APHP 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
Principal Investigator: Michel ZERAH, PUPH APHP
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01983345     History of Changes
Other Study ID Numbers: 2013-A00385-40
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016

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

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