In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM

NCT04770805 | Active Not Recruiting DMC

• 2 other identifiers: APHP191101N° IDRCB: 2020-A01413-36
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital (Paris, France).

Conditions

Sacral Myelomeningocele; Neural Tube Defects; Spina Bifida

Keywords

Sacral Myelomeningocele; MyeLDM; Fetal surgery; Fetoscopic Repair Program; Neural Tube Defect; Spina bifida

Outcome Measures

Primary Outcomes (1)

• Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality

  Successful complete closure of the defect using the fetoscopic technique AND birth after 32 weeks without severe perinatal morbidity and mortality including grade III-IV intra ventricular hemorrhage, severe, cerebral parenchyma hemorrhage, periventricular leukomalacia, grade III ulcero-necrotizing enterocolitis, severe bronchodysplasia)

  From time of surgery to 8 weeks of life (up to 28 weeks)

Secondary Outcomes (22)

• Adverse Maternal outcome

  during the surgery

• Maternal obstetric outcome as evidenced by preterm labor leading to delivery at less than 37 weeks of gestation

  From time of surgery until 37 weeks of gestation

• Maternal obstetric outcome as evidenced by preterm premature rupture of membranes

  From time of surgery until 37 weeks of gestation

• Maternal obstetric outcome as evidenced by chorioamnionitis

  From time of surgery until 37 weeks of gestation

• Maternal obstetric outcome as evidenced by antenatal betamethasone treatment

  From time of surgery until 34 weeks of gestation

Study Arms (1)

Fetoscopic repair

EXPERIMENTAL

Sacral Myelomeningocele and Mye-LDM Fetoscopic repair

Procedure: Fetoscopy

Interventions

Fetoscopy PROCEDURE

After an exteriorization of the uterus through a laparotomy, humidified and warmed gas will be insufflated with low pressure (6 to 8mmHg mmHg). Fetoscopic repair surgery will consist in a dissection of the placode, its reintegration into the spinal canal and the closure of the lesion, through a three ports access. After fetal surgery, the gas will be exsufflated and the trocar ports will be closed. The uterus will be reintegrated before suturing the maternal abdominal wall.

Fetoscopic repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women age 18 years and older who are able to consent
• Singleton pregnancy before 26 weeks of gestation,
• Sacral MMC (upper level S1 or below) or MyeLDM diagnosed on ultrasound and MRI, 4. Absence of associated malformation apart from the anomalies usually observed in cases of open dysraphisms (i.e. feet malpositions, associated cerebral signs) or chromosomal anomaly if verification of the karyotype was desired by the couple
• Affiliated to health insurance, understanding and speaking French
• Written consent of the patient for the surgery and representatives of the parental authority for the postnatal follow-up of the child
• Patient who made the choice to continue the pregnancy

You may not qualify if:

• Abnormal angulation of the fetal spine,
• Placenta praevia,
• BMI greater than 35 kg / m2,
• Abnormality of the uterus: large fibroid, uterine malformation, history of uterine body surgery
• Maternal infection at risk of maternal-fetal transmission: HIV, HBV, HCV,
• Surgical or anesthetic contraindication.
• Participation in another interventional research protocol,
• Patients under legal protection (guardianship, curatorship).
• Allergies to drugs used in the research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service médecine foetale-Hôpital Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Neural Tube Defects; Spinal Dysraphism

Interventions

Fetoscopy

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Fetal Therapies; Therapeutics; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures

Study Officials

• Lucie GUILBAUD, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm clinical study. All participants will undergo laparotomy with exteriorization of the uterus followed by fetoscopic repair of the fetal MMC/MyeLDM lesion.

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 25, 2021
• Study Start: April 16, 2021
• Primary Completion: November 24, 2024
• Study Completion: December 8, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

FR (1)