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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT06907732
Eligibility Criteria:
Inclusion Criteria:
* Isolated open fetal spina bifida
* Healthy pregnant patient without risk factors for preterm delivery
* Candidate for open fetal spina bifida surgery.
* Maternal age 18 years or more and able to consent
* Provision of written informed consent to participate in this study
* Gestational age allowing for fetal surgery prior to 26 weeks gestation.
Exclusion Criteria:
* Contraindication for surgery or safe anesthesia due to a severe maternal medical condition, including morbid obesity (BMI \>40 kg/m2)
* History of preterm birth, short cervical length, cervical cerclage
* Placenta or vasa previa, invasive placentation
* Inaccessibility of the uterus due to severe maternal obesity, uterine fibroids, bowel or placental superposition
* Major fetal structural or genetic anomalies unrelated to spina bifida, requiring surgery or potentially leading to infant death or severe handicap
* Neural tube defects other than open spina bifida
* Absence of Chiari II malformation on ultrasound or MRI
* Severe fetal kyphosis (\>30 degrees)
* Upper lesion level lower than sacral vertebra S1.
* Multiple gestation
* Fetal bleeding disorder (eg. Fetal/neonatal allo-immune thrombocytopenia)
* Maternal infectious disorder which could result in materno-fetal transmission (eg HIV with high viral load)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06907732
Study Brief:
Protocol Section:
NCT06907732