Fetal Tracheal Occlusion for Congenital Diaphragmatic Hernia
Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
Recruiting
N/A
Interventional Study
Congenital Diaphragmatic Hernia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Michael A Belfort · Other
Who this trial is looking for
This trial is looking for pregnant women with fetuses diagnosed with severe congenital diaphragmatic hernia (CDH). Participants will receive a procedure to help develop the fetus's lungs and must stay in Houston until delivery.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a pregnant woman aged 18 to 45.
- I have a singleton pregnancy.
- My fetus is between 28 and 31 weeks of gestation.
- My fetus has been diagnosed with severe CDH.
- My fetus has a normal heart or a minor heart issue that won't affect outcomes.
- My fetus has a normal genetic makeup.
- I am healthy enough for surgery.
- I agree to stay in Houston after the procedure until delivery.
You may not be able to join if
- I cannot have abdominal surgery or general anesthesia.
- I am allergic to latex.
- I have had an allergic reaction to a study medication.
- I am experiencing preterm labor or preeclampsia.
- My fetus has a known genetic disorder or major anomaly.
- There is a suspicion my fetus has a recognized syndrome.
- My BMI is over 40.
- I am at high risk for fetal hemophilia.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* Patient is a pregnant woman between 18 and 45 years of age
* Singleton pregnancy
* The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age
* Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.3…
Contacts