Actively Recruiting
Safety and Efficacy of FETO in CDH Phase III
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-09-22
75
Participants Needed
1
Research Sites
387 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
CONDITIONS
Official Title
Safety and Efficacy of FETO in CDH Phase III
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 years or older who can give consent
- Single pregnancy
- Gestational age less than 29 weeks at enrollment
- Intrathoracic liver herniation detected
- Isolated left CDH with observed-to-expected lung-to-head ratio (o/e LHR) less than 30% at enrollment between 18 and 29.5 weeks, or isolated right CDH with o/e LHR less than 45% at enrollment between 18 and 29.5 weeks
- Normal fetal karyotype confirmed by culture, CMA, WES, WGS, or FISH if over 26 weeks
- Cervical length greater than 20 mm by transvaginal ultrasound within 24 hours before FETO procedure
- Meets psychosocial criteria
- Informed consent understood
You will not qualify if you...
- Younger than 18 years old
- Multiple pregnancies
- History of natural rubber latex allergy
- Preterm labor, cervical length less than 20 mm at enrollment or within 24 hours before FETO balloon insertion, uterine anomalies strongly predisposing to preterm labor, or placenta previa
- Psychosocial issues preventing consent, including inability to live within 30 minutes of Cincinnati Children's Hospital or lack of a support person during pregnancy
- Bilateral CDH, isolated left CDH with o/e LHR 30% or greater, isolated right CDH with o/e LHR greater than 45%
- No liver herniation into thoracic cavity
- Additional fetal anomalies or chromosomal abnormalities affecting prognosis
- Maternal contraindications to fetoscopic surgery or severe maternal medical conditions
- History of incompetent cervix or cerclage
- Known placental abnormalities at enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia
- Maternal HIV, Hepatitis B or C positive status
- Uterine anomalies or fibroids prohibiting safe fetoscopic procedure
- No safe or feasible fetoscopic approach for balloon placement
- Participation in another intervention study affecting maternal or fetal outcomes or prior participation in this trial during a previous pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
F
Foong-Yen Lim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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