Prenatal Surgical Repair of Fetal Myelomeningocele (PRIUM)
Primary Purpose
Foetus With Myelomeningocele
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prenatal surgical repair of fetal myelomeningocele
Sponsored by
About this trial
This is an interventional treatment trial for Foetus With Myelomeningocele focused on measuring Myelomeningocele, Arnold Chiari malformation, Spina bifida
Eligibility 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)
Sites / Locations
- Hopital Armand Trousseau, APHP
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Case - open surgical repair
Arm Description
No prenatal surgical repair of myelomeningocele
Prenatal surgical repair of fetal myelomeningocele
Outcomes
Primary Outcome Measures
Arnold Chiari anomaly at birth
the existence of an Arnold Chiari anomaly at birth
Defect
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01983345
First Posted
November 7, 2013
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01983345
Brief Title
Prenatal Surgical Repair of Fetal Myelomeningocele
Acronym
PRIUM
Official Title
Prenatal Surgical Repair of Fetal Myelomeningocele
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2014 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
July 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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, 12 months and 36 months of age. Those data will be matched to controls who have underwent a conventional postnatal repair of the SB
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foetus With Myelomeningocele
Keywords
Myelomeningocele, Arnold Chiari malformation, Spina bifida
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No prenatal surgical repair of myelomeningocele
Arm Title
Case - open surgical repair
Arm Type
Experimental
Arm Description
Prenatal surgical repair of fetal myelomeningocele
Intervention Type
Procedure
Intervention Name(s)
prenatal surgical repair of fetal myelomeningocele
Intervention Description
open surgical repair of myelomeningocele before 26 weeks gestational age
Primary Outcome Measure Information:
Title
Arnold Chiari anomaly at birth
Description
the existence of an Arnold Chiari anomaly at birth
Time Frame
Day 0
Title
Defect
Description
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)
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Zerah, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean-Marie Jouannic, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Armand Trousseau, APHP
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
Learn more about this trial
Prenatal Surgical Repair of Fetal Myelomeningocele
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