Status:
ACTIVE_NOT_RECRUITING
In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Sacral Myelomeningocele
Neural Tube Defects
Eligibility:
FEMALE
18+ years
Phase:
NA
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 repai...
Detailed Description
Myelomeningocele and Myelic limited dorsal myeloschisis (MyeLDM) correspond to neural tube defects which lead to lifelong disabilities including lower extremity paralysis, sphincters deficiency, and c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04770805
Start Date
April 16 2021
End Date
December 8 2025
Last Update
August 14 2025
Active Locations (1)
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1
Service médecine foetale-Hôpital Trousseau
Paris, France, 75012