Status:
NO_LONGER_AVAILABLE
Percutaneous Endoscopic Tracheal Plug/Unplug for CDH (Congenital Diaphragmatic Hernia)
Lead Sponsor:
University of California, San Francisco
Conditions:
Severe Congenital Diaphragmatic Hernia
Eligibility:
FEMALE
18+ years
Brief Summary
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera...
Eligibility Criteria
Inclusion
- General subject population: Pregnant women in the second trimester, at least 18 years of age, and of any and all ethnic backgrounds.
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00768703
Last Update
March 27 2019
Active Locations (1)
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1
University of California, San Francisco Fetal Treatment Center
San Francisco, California, United States, 94143