FETO Treatment for Congenital Diaphragmatic Hernia
Safety and Efficacy of FETO in CDH Phase III
- Age
- 18 – 50
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 75 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Other
This trial is looking for pregnant women with specific types of congenital diaphragmatic hernia to participate in a treatment involving tracheal occlusion. Participants will need to be able to consent and meet certain health criteria.
You may be able to join if
- I am a pregnant woman 18 years or older.
- I have a singleton pregnancy.
- I am between 180 to 295 weeks pregnant.
- I have intrathoracic liver herniation.
- I have isolated Left CDH with lung-to-head ratio below 30%.
- I have isolated Right CDH with lung-to-head ratio below 45%.
- I have a normal fetal karyotype confirmed by tests.
- I have a cervical length over 20 mm.
You may not be able to join if
- I am under 18 years of age.
- I have a multi-fetal pregnancy.
- I have a history of natural rubber latex allergy.
- I have preterm labor or a shortened cervix.
- I cannot travel to Cincinnati Children's Hospital Medical Center.
- I have bilateral CDH or specific abnormal lung-to-head ratio thresholds.
- I have additional fetal anomalies or genetic syndromes.
- I have a severe medical condition during pregnancy.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your EligibilityTracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
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