Prenatal Surgical Repair of Fetal Myelomeningocele (PRIUM)

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.

Study Overview

• Status: Completed
• Conditions: Foetus With Myelomeningocele
• Intervention / Treatment: 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, 12 months and 36 months of age. Those data will be matched to controls who have underwent a conventional postnatal repair of the SB

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Hopital Armand Trousseau, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arnold Chiari anomaly at birth	the existence of an Arnold Chiari anomaly at birth	Day 0
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)	3 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2014
• Primary Completion (Actual): July 28, 2021
• Study Completion (Actual): July 28, 2021

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Myelomeningocele; Spina bifida; Arnold Chiari malformation
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica
• Other Study ID Numbers: P121103; 2013-A00385-40 (Registry Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No