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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT00060606
Eligibility Criteria:
Inclusion Criteria
* Pregnant women carrying a fetus diagnosed with myelomeningocele
* Myelomeningocele lesion that starts no higher than T1 and no lower than S1 with hindbrain herniation present
* Gestational age at randomization of 19 weeks 0 days to 25 weeks 6 days
* Normal karyotype
* Singleton pregnancy
* United States resident
* Able to travel to study site for study evaluation, procedures, and visits (if randomized to prenatal surgery, must stay near center until delivery)
* Support person to travel and stay with participant
Exclusion Criteria
* Maternal insulin-dependent pregestational diabetes
* Short or incompetent cervix or cervical cerclage
* Placenta previa
* Body mass index of 35 or more
* Previous spontaneous delivery prior to 37 weeks
* Maternal HIV, Hepatitis-B or Hepatitis-C status positive
* Uterine anomaly
* Maternal medical condition which is a contraindication to surgery or general anesthesia
* Other fetal anomaly
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00060606
Study Brief:
Protocol Section:
NCT00060606