The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
Patient <18 years of age
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, short cervix (<20mm within 24 hours of FETO balloon insertion procedure), or uterine anomaly strongly predisposing to preterm labor, placenta previa
Dr Erin Perrone
Lead sponsor
University of Michigan
Sponsor institution