Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The baby has been diagnosed with an isolated congenital diaphragmatic hernia (a hole in the diaphragm) with the liver pushed up into the chest cavity.
• Ultrasound measurements show the baby's lungs are severely underdeveloped (a specific measurement called O/E LHR is below 25%), and the planned procedure would take place between 27 weeks and 29 weeks and 6 days of pregnancy.
• Ultrasound measurements show the baby's lungs are moderately underdeveloped (O/E LHR below 30%, with liver up), and the planned procedure would take place between 30 weeks and 31 weeks and 6 days of pregnancy.
• The pregnant person is 18 years of age or older.
• Enrollment happens before 29 weeks and 6 days of pregnancy (or before 31 weeks and 6 days for the moderate category).
• The baby has a normal chromosome result confirmed by standard genetic testing.
• The baby has a normal heart scan (echocardiogram).
• It is a single (not multiple) pregnancy.
• The family is willing to stay in the greater Cincinnati area for the rest of the pregnancy.
• The family has considered and declined the option of ending the pregnancy before 24 weeks.
• The family meets certain emotional and social support criteria assessed by the trial team.

Who may not be able to join:

• The pregnant person is under 18 years old.
• It is a pregnancy with more than one baby (e.g., twins or more).
• There is a known allergy to rubber latex.
• There are signs of early labour, a short cervix (less than 15 mm), a uterine shape that strongly increases the risk of early labour, or the placenta is covering the cervix (placenta previa).
• The baby has the hernia on both sides, or has a left-sided hernia with a lung measurement above 30%.
• The baby has any additional abnormality found on ultrasound, MRI, or heart scan.
• The baby has a chromosomal abnormality.
• There are medical reasons why the pregnant person cannot safely have a fetoscopic (keyhole) procedure, or there is a serious pregnancy-related health condition.
• The cervix is weakened (incompetent), with or without a surgical stitch already in place.
• There are known problems with the placenta at the time of enrollment.
• The pregnant person has HIV, Hepatitis B, or Hepatitis C.
• The pregnant person has an abnormally shaped uterus.
• There is no safe or technically possible way to perform the balloon placement procedure.
• The person is already taking part in another study that could affect the health outcomes of the pregnant person or baby, or has taken part in this same trial in a previous pregnancy.

Important: Always verify eligibility with the trial site directly before applying.