NCT03281798 Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction
| NCT ID | NCT03281798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rodrigo Ruano |
| Condition | Lower Urinary Tract Obstructive Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2018-01-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).
Eligibility Criteria
Inclusion Criteria: 1. Pregnant women 2. Singleton pregnancy 3. Maternal age ≥ 18 years 4. Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis 5. Oligohydramnios or Anhydramnios 6. Favorable urine analysis defined as urinary sodium is \< 100 milliequivalents per liter (mEq/L), chloride \< 90 mEq/L, and osmolality \< 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy). 7. Absence of chromosomal abnormalities and associated anomalies 8. Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks 9. Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded. 10. Family have considered and declined the option of termination of the pregnancy at less than 24 weeks. 11. Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study. 12. Parents or guardian are willing to provide signed informed consent. Exclusion Criteria: 1. Fetal anomaly unrelated to LUTO 2. Congenital cardiac anomaly 3. Female fetus 4. Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth 5. Placental abnormalities (previa, abruption, accreta) known at time of enrollment 6. Contraindications to surgery including previous hysterotomy in active uterine segment 7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy 8. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy 9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment 10. Maternal medical condition that is a contraindication to surgery or anesthesia 11. Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure. 12. Inability to comply with travel and follow-up requirements of the trial 13. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy 14. Patients declining invasive testing 15. Family does not meet psychosocial criteria including insufficient
Contact & Investigator
Rodrigo Ruano, MD, PhD.
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT03281798 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Lower Urinary Tract Obstructive Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03281798 currently recruiting?
Yes, NCT03281798 is actively recruiting participants. Contact the research team at rodrigo.ruano@miami.edu for enrollment information.
Where is the NCT03281798 trial being conducted?
This trial is being conducted at Miami, United States, Rochester, United States.
Who is sponsoring the NCT03281798 clinical trial?
NCT03281798 is sponsored by Rodrigo Ruano. The principal investigator is Rodrigo Ruano, MD, PhD. at University of Miami. The trial plans to enroll 10 participants.