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New treatment option for Congenital Diaphragmatic Hernia
Official title Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
ClinicalTrials.gov ID: NCT02986087
What this study is testing
- What it's testing
- Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- Isolated CDH with liver up
- Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery
- Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
- Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery
- Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
You likely can't join if
- Patient \< 18 years old
- Multi-fetal pregnancy
- Rubber latex allergy
- Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Bilateral CDH, isolated left sided CDH with an O/E \> 30%
- Additional fetal anomaly by ultrasound, MRI, or echocardiogram
See the full eligibility criteria
- Isolated CDH with liver up
- Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery
- Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
- Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery
- Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
- Maternal age greater than or equal to 18 years
- Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
- Normal karyotype or FISH
- Normal fetal echocardiogram
- Singleton pregnancy
- Willing to remain in the greater Cincinnati area for remainder of pregnancy
- Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
- Family meets psychosocial criteria
- Patient \< 18 years old
- Multi-fetal pregnancy
- Rubber latex allergy
- Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Bilateral CDH, isolated left sided CDH with an O/E \> 30%
- Additional fetal anomaly by ultrasound, MRI, or echocardiogram
- Chromosomal abnormalities
- Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
- Incompetent cervix with or without a cerclage
- Placental abnormalities known at time of enrollment
- Maternal HIV, Hepatits B, Hepatitis C
- Maternal uterine anomaly
- No safe or technically feasible fetoscopic approach to balloon placement
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.