Clinical Research Directory

Inclusion Criteria: * Women carrying a fetus with isolated CDH eligible for FETO, i.e. with severe or moderate hypoplasia: * Left sided CDH with severe (i.e. quotient of observed-to-expected- lung-to-head ratio under 25%) or moderate pulmonary hypoplasia (observed-to-expected- lung-to-head ratios of 25 to 34.9% (any liver position), or 35 to 44.9% with intrathoracic liver herniation) * Right sided CDH with severe pulmonary hypoplasia (quotient of observed-to-expected- lung-to-head ratio under 50%) * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * Maternal age of 18 years or older * Single pregnancy * Signed informed consent * Consent to have an ultrasound of the uterus after delivery when indicated * Postnatal management center agrees to participate Exclusion Criteria: Participants eligible for this Trial must not meet any of the following criteria: * History of allergy to latex * Contraindication to fetoscopy and FETO (maternal diseases or technical limitations making prenatal surgery hazardous or impossible) * Premature Membrane Rupture (PROM) * Multiple pregnancy * Maternal age less than 18 years * Refusal to stay close to the UZ Leuven until balloon removal * Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol * Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial * Participation in another interventional trial with an investigational medicinal product (IMP) or device