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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00881660
Eligibility Criteria:
INCLUSION CRITERIA:
* Patient is a pregnant woman between 18 and 45 years of age
* Singleton pregnancy
* Confirmed diagnosis of severe or extremely severe left, right or bilateral CDH of the fetus
Severe CDH: -Fetal liver herniated into the hemithorax -Lung-head ratio (LHR) is less than or equal to 1.0 calculated between 27+0/7 and 29+6/7 weeks' gestation
Extremely Severe CDH: -At least 1/3rd of the liver parenchyma herniated into the thoracic cavity -Lung-head ratio (LHR) is \< 0.71 calculated between 22+0/7 and 29+6/7 weeks' gestation
* Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
* Normal fetal karyotype
* The mother must be healthy enough to have surgery
* Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
* Patient willing to remain in Houston for the duration following the balloon placement until delivery
* Signed informed consent
EXCLUSION CRITERIA:
* Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
* Allergy to latex
* Allergy or previous adverse reaction to a study medication specified in this protocol
* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
* Fetal aneuploidy, known structural genomic variants, other major fetal anomalies, or known syndromic mutation
* Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
* Maternal BMI \>40
* High risk for fetal hemophilia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00881660
Study Brief:
Protocol Section:
NCT00881660