Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT04770805
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04770805
Study Brief:
Protocol Section:
NCT04770805