Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07166172

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

Led by Johns Hopkins University · Updated on 2026-04-23

80

Participants Needed

1

Research Sites

336 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

K

KARL STORZ Endoscopy-America, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.

CONDITIONS

Official Title

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women age 18 years and older
  • Singleton pregnancy
  • Normal karyotype, chromosomal microarray, whole exome or whole genome sequencing with non-pathologic variants; fluorescent in situ hybridization acceptable if >26 weeks gestation
  • Gestational age before 29 weeks + 6 days at enrollment
  • Intrathoracic liver herniation with isolated left CDH and o/e LHR < 30% at enrollment (18wks + 0 days to 29wks + 5 days gestation)
  • Intrathoracic liver herniation with isolated right CDH and o/e LHR ≤ 45% at enrollment (18wks + 0 days to 29wks + 5 days gestation)
  • Cervical length ≥ 20 mm by transvaginal ultrasound within 24 hours before FETO
  • Meets psychosocial criteria
  • Provides informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Multi-fetal pregnancy
  • History of natural rubber latex allergy
  • Preterm labor, cervix shortened (<20 mm at enrollment or within 24 hours of FETO balloon insertion), or uterine anomaly strongly predisposing to preterm labor
  • Placenta previa
  • Psychosocial ineligibility including inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy or no support person available during pregnancy
  • Bilateral CDH, isolated left CDH with o/e LHR ≥ 30%, or isolated right CDH with o/e LHR > 45% at enrollment
  • No liver herniation into thoracic cavity
  • Additional fetal anomalies or chromosomal abnormalities affecting survival prognosis
  • Maternal contraindications to fetoscopic surgery or severe maternal medical conditions in pregnancy
  • History of incompetent cervix with or without cerclage
  • Known placental abnormalities (previa, abruption, accreta) at enrollment
  • Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia
  • Maternal positive HIV, Hepatitis B, or Hepatitis C status or unknown status without negative test before enrollment
  • Uterine anomalies such as large or multiple fibroids or Mullerian duct abnormality
  • No safe or technically feasible fetoscopic approach for balloon placement
  • Participation in another intervention study affecting maternal and fetal outcomes or previous participation in this trial during a prior pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

A

Ahmet Baschat, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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