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:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT02390895
Eligibility Criteria:
Inclusion Criteria:
* Patient \> 18 years old, with an assumption by health insurance, understanding and speaking French
* A term \< or = 26 +0 weeks gestational age
* Single-Pregnancy
* Myelomeningocele with higher-level defect between S1 and T1
* Arnold Chiari anomaly
* No associated anomaly or chromosic anomaly
Exclusion Criteria:
* severe foetal kyphoscoliosis associated
* Increased risk of preterm birth: cervical length \<15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane
* placenta previa, accreta or placental abruption
* Maternal obesity with BMI\> 35
* Uterine anomalies : large interstitial uterine fibroid, uterine malformation
* maternal infection with a foetal transmission risk: HIV, HBV, HCV
* Maternal contradiction in surgery or anesthesia
* poor social status and/or social isolation
* impossible post-surgery follow-up
* want to have a medical pregnancy termination
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02390895
Study Brief:
Protocol Section:
NCT02390895