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RecruitingNCT03281798

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

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Trial Parameters

ConditionLower Urinary Tract Obstructive Syndrome
SponsorRodrigo Ruano
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment10
SexFEMALE
Min Age18 Years
Max AgeN/A
Start Date2018-01-01
Completion2028-08-01
Interventions
FetoscopesFetal Cystoscopy

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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 s

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