Prenatal Surgical Repair of Fetal Myelomeningocele

NCT ID: NCT01983345

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-10
• Study Completion Date: 2021-07-28

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

Conditions

Foetus With Myelomeningocele

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

No prenatal surgical repair of myelomeningocele

Group Type: NO_INTERVENTION

No interventions assigned to this group

Case - open surgical repair

Prenatal surgical repair of fetal myelomeningocele

Group Type: EXPERIMENTAL

prenatal surgical repair of fetal myelomeningocele

Intervention Type: PROCEDURE

open surgical repair of myelomeningocele before 26 weeks gestational age

Interventions

prenatal surgical repair of fetal myelomeningocele

open surgical repair of myelomeningocele before 26 weeks gestational age

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Zerah, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Jean-Marie Jouannic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital Armand Trousseau, APHP

Paris, PARIS, France

Countries

France

References

Friszer S, Dhombres F, Di Rocco F, Rigouzzo A, Garel C, Guilbaud L, Forin V, Moutard ML, Zerah M, Jouannic JM. [Preliminary results from the French study on prenatal repair for fetal myelomeningoceles (the PRIUM study)]. J Gynecol Obstet Biol Reprod (Paris). 2016 Sep;45(7):738-44. doi: 10.1016/j.jgyn.2015.09.002. Epub 2015 Nov 10. French.

Reference Type: BACKGROUND

PMID: 26566108 (View on PubMed)

Guilbaud L, Maurice P, Lallemant P, De Saint-Denis T, Maisonneuve E, Dhombres F, Friszer S, Di Rocco F, Garel C, Moutard ML, Lachtar MA, Rigouzzo A, Forin V, Zerah M, Jouannic JM. Open fetal surgery for myelomeningocele repair in France. J Gynecol Obstet Hum Reprod. 2021 Nov;50(9):102155. doi: 10.1016/j.jogoh.2021.102155. Epub 2021 Apr 26.

Reference Type: BACKGROUND

PMID: 33915336 (View on PubMed)

Other Identifiers

2013-A00385-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

P121103

Identifier Type: -

Identifier Source: org_study_id