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 range18 Years
SexFEMALE
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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
✕. 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
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