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Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.

⁃ Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.

⁃ Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.

⁃ Parents or guardian are willing to provide signed informed consent.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Minnesota
Mayo Clinic
TERMINATED
Rochester
Contact Information
Primary
Rodrigo A Ruano, MD, PhD.
rodrigo.ruano@miami.edu
305.243.0769
Time Frame
Start Date: 2018-01-01
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 10
Treatments
Experimental: Fetal Cystoscopy Group
Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.
Related Therapeutic Areas
Sponsors
Leads: Rodrigo Ruano

This content was sourced from clinicaltrials.gov

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