Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
United States10 participantsStarted 2024-05-01
Plain-language summary
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Singleton pregnancy
* Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks.
* Isolated Left CDH with liver up
* Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) \< 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to \<30% (measured at 300 to 316 weeks) at time of surgery.
* Gestational age at FETO procedure with O/E LHR \<25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to \<30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
* Patient meets psychosocial criteria
Exclusion Criteria:
* Multi-fetal pregnancy
* 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:
* Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
* Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
* Right sided CDH or bilateral CDH, isolated left sided with…
What they're measuring
1
Number of successfully completed FETO procedures
Timeframe: Up to 34 weeks gestation
2
Operative time
Timeframe: Up to 34 weeks gestation
3
Frequency of unplanned balloon removal
Timeframe: Up to 34 weeks gestation
4
Number of incidences of maternal complications
Timeframe: Up to 41 weeks gestation
5
Number of participants with maternal complications