Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (NCT03281798) | Clinical Trial Compass
RecruitingNot Applicable
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction
United States10 participantsStarted 2018-01-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pregnant women
. Singleton pregnancy
. Maternal age ≥ 18 years
. Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
. Oligohydramnios or Anhydramnios
. 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).
. Absence of chromosomal abnormalities and associated anomalies
. Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
Exclusion criteria
. Fetal anomaly unrelated to LUTO
. Congenital cardiac anomaly
. Female fetus
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants where the procedure was technically performed
Timeframe: Day 1 (Post fetal cystoscopy procedure)
2
Number of participants where the etiology of LUTO was correctly diagnosed
Timeframe: Up to 1 month post delivery
3
Number of participants where the posterior urethral valve were successfully released
Timeframe: Day 1 (Post fetal cystoscopy procedure)
4
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia
Timeframe: Up to 1 month post delivery
5
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment
Timeframe: Up to 24 months post delivery
6
Number of participants whose fetal cystoscopy resulted in maternal complications
. Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
. Contraindications to surgery including previous hysterotomy in active uterine segment
. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy