Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old…. meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.

Inclusion Criteria:

• Isolated CDH with liver up
• Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery
• Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
• Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery
• Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
• Maternal age greater than or equal to 18 years
• Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
• Normal karyotype or FISH
• Normal fetal echocardiogram
• Singleton pregnancy
• Willing to remain in the greater Cincinnati area for remainder of pregnancy
• Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
• Family meets psychosocial criteria

Exclusion Criteria:

• Patient < 18 years old
• Multi-fetal pregnancy
• Rubber latex allergy
• Preterm labor, cervix shortened (<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• Bilateral CDH, isolated left sided CDH with an O/E > 30%
• Additional fetal anomaly by ultrasound, MRI, or echocardiogram
• Chromosomal abnormalities
• Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
• Incompetent cervix with or without a cerclage
• Placental abnormalities known at time of enrollment
• Maternal HIV, Hepatits B, Hepatitis C
• Maternal uterine anomaly
• No safe or technically feasible fetoscopic approach to balloon placement
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy