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Tests treatment safety and results for Congenital Diaphragmatic Hernia
Official title Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)
ClinicalTrials.gov ID: NCT07577414
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- FETO Intervention Arm:
- 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
You likely can't join if
- 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...
- History of incompetent cervix with or without cerclage
- Psychosocial ineligibility
See the full eligibility criteria
Who can join
- FETO Intervention Arm:
- 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
- Normal fetal karyotype, Chromosomal Microarray (CMA) with non-pathologic variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable...
- Gestational age at enrollment prior to 29w6d
- Fetal CDH with intrathoracic liver herniation with either:
- Isolated left CDH with Observed/Expected (o/e) Lung to Head Ratio (LHR) \<30% at enrollment (18w0d-29w5d)
- Isolated right CDH with o/e LHR \<45% at enrollment (18w0d-29w5d)
- Cervical length by transvaginal ultrasound \>20 mm within 24hours of FETO procedure
- Meets psychosocial criteria
- Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
- Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with participant for the duration of the pregnancy near Von Voigtlander Women's Hospital
- Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work (work from home approved by Principal Investigator is okay) Expectant Management Arm:
- 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
- Normal fetal karyotype, CMA with non-pathologic variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \>26 weeks. (non-intervention arm can have karyotype or...
- Gestational age at enrollment prior to 29w6d
- Fetal CDH with intrathoracic liver herniation with either:
- Isolated left CDH with o/e LHR \<30% at enrollment (18w0d-29w5d)
- Isolated right CDH with o/e LHR \<45% at enrollment (18w0d-29w5d)
- Meets psychosocial criteria
- Ability to maintain follow up appointments FETO Intervention Arm:
What rules you out
- 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
- History of incompetent cervix with or without cerclage
- Psychosocial ineligibility
- Inability to reside within 30 minutes of Von Voigtlander Women's Hospital or inability to maintain follow up appointments
- Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude participant as a potential candidate...
- Bilateral CDH, isolated Left Congenital Diaphragmatic Hernia (LCDH) with o/e LHR \> 30% (measured at 180 to 295 weeks), isolated Right Congenital Diaphragmatic Hernia (RCDH) with o/e LHR \>45% (measured at 180 to 295...
- No liver herniation into the thoracic cavity.
- Additional fetal anomaly or genetic/chromosomal abnormalities recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, MRI or...
- Maternal contraindications to elective fetoscopic surgery or severe maternal medical condition in pregnancy
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment and/or surgery
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal Human Immunodeficiency Virus (HIV), Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure. If the patient's HIV...
- No safe or technically feasible fetoscopic approach to balloon placement
- Uterine anomalies such as large fibroids or Mullerian duct abnormality
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy Expectant Management Arm: Exclusion Criteria:
- Patient \<18 years of age
- Multi-fetal pregnancy
- Preterm labor, short cervix (\<20mm), or uterine anomaly strongly predisposing to preterm labor, placenta previa
- History of incompetent cervix with or without cerclage
- Psychosocial ineligibility
- Inability to maintain follow up appointments
- Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude participant as a potential candidate.
- Bilateral CDH, isolated LCDH with o/e LHR \> 30% (measured at 180 to 295 weeks), isolated RCDH with o/e LHR \>45% (measured at 180 to 295 weeks), or any isolated CDH without intrathoracic liver herniation as determined...
- Additional fetal anomaly or genetic/chromosomal abnormalities recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, Magnetic...
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.