Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Exclusion Criteria

• •1. Multi-fetal pregnancy
• •2. History of latex allergy
• •3. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
• •4. Psychosocial ineligibility
• •* Inability to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) or inability to maintain follow up appointments
• •* Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
• •5. Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
• •6. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
• •7. Maternal contraindications to elective fetoscopic surgery
• •8. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
• •9. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
• •10. No safe or feasible fetoscopic approach to balloon placement
• •11. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
• •12. Participation in another intervention study that influences maternal and fetal morbidity and mortality.