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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT06056635
Eligibility Criteria:
Inclusion Criteria:
* Pregnant patient with a condition requiring in-utero surgery
* Patient must be eligible for anesthesia
* Patient and father of the fetus (if available) are able to provide signed informed consent
Exclusion Criteria:
* Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
* Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
* Pre-pregnancy maternal BMI greater than 40
* High risk for fetal hemophilia
* Fetal aneuploidy or variants of known significance if an amniocentesis was performed
* Contraindication to abdominal surgery or fetoscopic surgery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06056635
Study Brief:
Protocol Section:
NCT06056635