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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT03090633
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women age 18 years and older who are able to consent
* Singleton pregnancy
* Normal fetal karyotype
* Isolated fetal spina bifida with the upper lesion level between T1-S1
* Gestational age between 19+0 to 25+6 weeks gestation
Exclusion Criteria:
* Pregnant women less than 18 years of age
* Multiple gestation
* Fetal anomaly unrelated to spina bifida
* Maternal contraindication to fetoscopic surgery
* Severe maternal medical condition in pregnancy
* Technical limitations preluding fetoscopic surgery
* Preterm labor
* Cervical length \< 25mm
* Placenta previa
* Psychosocial ineligibility precluding consent
* Maternal Beck Depression Inventory score ≥ 17
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03090633
Study Brief:
Protocol Section:
NCT03090633