Clin2
NCT07187206Possibly a fitRecruiting

Fetoscopic surgery for severe diaphragmatic hernia

Congenital Diaphragmatic HerniaPulmonary HypoplasiaPulmonary Hypertension

Part of Genetic & congenital, Heart & circulation, Lungs & breathing clinical trials.

This trial tests if a special surgery (FETO) done while the baby is still in the womb can improve survival for babies with a severe form of congenital diaphragmatic hernia (CDH). The surgery places a small balloon in the baby's windpipe to help the lungs grow. We are looking for pregnant women whose baby has a left-sided CDH with a lung-to-head ratio (LHR) less than 30%, or a right-sided CDH with LHR less than 45%, and whose liver is herniated into the chest.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
75 people
Ages
18 years to 50 years
Study type
Interventional

Who can take part

  • You are at least 18 years old and pregnant with one baby.
  • Your baby has a severe left or right diaphragmatic hernia (a hole in the muscle that separates the chest and belly).
  • The baby's liver is pushed up into the chest (liver herniation).
  • You must be less than 29 weeks and 6 days pregnant when you join the trial.
  • You are able to stay near the hospital (within 30 minutes) for the rest of your pregnancy and have a support person with you.
  • You do not have any condition that makes the surgery unsafe, like a short cervix, placenta problems, or certain infections (HIV, hepatitis B or C).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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