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Back to Pulmonary Hypertension
Phase 3 Pulmonary Hypertension Trial, Recruiting
NCT07187206
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Pregnant women aged 18 or older who are able to give informed consent
- Those carrying a single baby (not twins or more)
- Those enrolled before 29 weeks and 6 days of pregnancy
- The baby has part of the liver moved up into the chest cavity
- The baby has a left-sided diaphragmatic hernia (a gap in the left side of the diaphragm) with a specific lung measurement below 30%, measured between 18 and 29 weeks and 5 days of pregnancy
- The baby has a right-sided diaphragmatic hernia (a gap in the right side of the diaphragm) with a specific lung measurement below 45%, measured between 18 and 29 weeks and 5 days of pregnancy
- The baby's chromosomes have been tested and confirmed to be normal through an approved genetic test
- A cervical length measurement taken by internal ultrasound within 24 hours before the procedure shows the cervix is longer than 20mm
- Psychosocial criteria set by the trial site have been met
- Full understanding of the consent process has been confirmed
Who may not be able to join:
- Women under 18 years of age
- Those carrying more than one baby
- Those with a known allergy to natural rubber latex
- Those experiencing early labour, a cervix shorter than 20mm, a uterus shape that strongly increases the risk of early labour, or a placenta blocking the birth canal
- Those unable to live within 30 minutes of Cincinnati Children's Hospital Medical Center, or unable to meet the travel requirements for follow-up visits during the trial
- Those who do not have a support person (such as a partner, spouse, or parent) able to stay with them for the duration of the pregnancy at Cincinnati Children's Hospital Medical Center
- The baby has diaphragmatic hernias on both sides, or lung measurements that fall at or above the thresholds listed in the inclusion criteria
- The baby's liver has not moved into the chest cavity
- The baby has additional physical differences, heart conditions, or a diagnosed genetic syndrome that is known to affect survival chances
- There is a medical reason the mother cannot safely have the type of surgical procedure used in this trial
- There is a history of cervical weakness, with or without a cervical stitch
- Known placenta problems (such as placenta previa, abruption, or accreta) at the time of joining
- Certain blood incompatibility conditions between mother and baby affecting the current pregnancy
- A confirmed positive test for HIV, Hepatitis B, or Hepatitis C (if HIV status is unknown, a negative test result must be confirmed before joining the trial)
- A positive Hepatitis B surface antigen or Hepatitis C detected in the mother's blood, or a uterus shape or fibroid growths that would make the procedure unsafe
- No safe or technically possible approach exists for placing the balloon used in the procedure
- Current participation in another study that could affect outcomes for mother or baby, or previous participation in this same trial in an earlier pregnancy
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Phone: (513) 636-6259
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
30 September 2025
Est. completion
1 December 2032
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Change lung growth on prenatal imaging
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.