In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM (NCT04770805) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM
France10 participantsStarted 2021-04-16
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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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
What they're measuring
1
Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality
Timeframe: From time of surgery to 8 weeks of life (up to 28 weeks)