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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00768703
Eligibility Criteria:
General subject population: Pregnant women in the second trimester, at least 18 years of age, and of any and all ethnic backgrounds.
Inclusion Criteria:
* Confirmed diagnosis of CDH
* Normal fetal echocardiogram
* Normal karyotype
* Fetal liver herniated into the left hemithorax
* Lung-head ratio (LHR) is 1.0 or less, calculated between 24-26 weeks' gestation
* Fetus is between 26 and 28 weeks' gestation
* Singleton pregnancy
* Mother meets psychosocial criteria
* Pre-authorization from third-party payor for fetal intervention, or ability to self-pay.
Exclusion Criteria:
* Failure to meet all inclusion criteria
* Other congenital anomalies detected on ultrasound
* Contraindication to abdominal surgery or general anesthesia
* Allergy to latex
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
* Family unable or refuses to stay in San Francisco for duration of the tracheal occlusion period and for the duration of the pregnancy as medically necessary.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00768703
Study Brief:
Protocol Section:
NCT00768703