Clinical Trials

Inclusion Criteria

• Pregnant women age 18 years and older.
• Singleton pregnancy.
• Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26weeks.
• Isolated Left CDH with liver up.
• Gestation age at enrollment is less than or equal to 31 weeks plus 6 days as determined by clinical information (LMP) and evaluation of first ultrasound.
• In this study we will classify potential participants as either Extremely Severe CDH; Severe CDH; or CDH based on the O/E LHR:
  • Extremely Severe CDH is defined as O/E LHR of <20%measured at 180 to 296 weeks;
  • Severe CDH is defined as O/E LHR of 20% to <25% (measured at 180 to 296 weeks);
  • CDH for the purposes of this study is defined as O/E LHR of 25% to <30% (measured at 18 to 31 weeks).
  • Gestational age at FETO procedure will be
  • at 22 weeks 0 days to 29 weeks 6 days for fetuses with O/E LHR <20%
  • at 27 weeks 0 days to 29 weeks 6 days for fetuses with O/E LHR <25%
  • at 30 weeks 0 days to 31 weeks 6 days for fetuses with O/E LHR between 25% and <30%
• Patient meets psychosocial criteria.
• Informed consent.

Exclusion Criteria

• Pregnant women < 18 years.
• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.
• Technical limitations precluding fetoscopic surgery.
• History of natural rubber latex allergy.
• Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa.
• Psychosocial ineligibility, precluding consent.
• Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.
• Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care.