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Clinical Trials in France / NCT04770805
Active, not recruiting Not applicable

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

NCT04770805 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2021-04-16
Last updated
2025-08-14

Condition(s) studied

Sacral MyelomeningoceleNeural Tube DefectsSpina Bifida

Investigational drug(s) / intervention(s)

Fetoscopy

Fetoscopy: 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.

Study 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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Inclusion Criteria : * 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 Exclusion Criteria: * Abnormal angulation of the fetal spine, * risk factors for prematurity: cervical length less \< 15mm, history of late miscarriage before 22 weeks, pre-existing rupture of the membranes at inclusion, * 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

Primary outcome measure(s)

  • Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality — From time of surgery to 8 weeks of life (up to 28 weeks)
    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)

Trial sites (1)

FacilityCityRegionStatus
Service médecine foetale-Hôpital Trousseau Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04770805 on ClinicalTrials.gov ↗ ← All trials in France