Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT03281798

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Led by Rodrigo Ruano · Updated on 2026-02-24

10

Participants Needed

2

Research Sites

552 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women
  • Singleton pregnancy
  • Maternal age 18 years or older
  • Male fetus with LUTO, dilated bladder, keyhole sign, and bilateral hydronephrosis
  • Presence of oligohydramnios or anhydramnios
  • Favorable fetal urine analysis after 20 weeks: urinary sodium < 100 mEq/L, chloride < 90 mEq/L, osmolality < 200 mOsm/kg
  • No previous in utero intervention for LUTO
  • Absence of chromosomal abnormalities and other anomalies
  • Gestational age between 16 0/7 and 25 6/7 weeks at time of procedure
  • Normal karyotype confirmed by invasive testing (amniocentesis or CVS); patients refusing invasive testing are excluded
  • Family has considered and declined pregnancy termination before 24 weeks
  • Family meets psychosocial criteria including social support and understanding of study
  • Parents or guardian willing to provide signed informed consent
Not Eligible

You will not qualify if you...

  • Fetal anomalies unrelated to LUTO
  • Congenital cardiac anomalies
  • Female fetus
  • Increased risk for preterm labor such as short cervical length (<1.5 cm), history of incompetent cervix, or previous preterm birth
  • Known placental abnormalities (previa, abruption, accreta) at enrollment
  • Contraindications to surgery including prior hysterotomy in active uterine segment
  • Technical limitations preventing fetoscopic surgery (e.g., uterine fibroids, membrane separation, incompatible uterine anomalies)
  • Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting current pregnancy
  • Positive maternal HIV, Hepatitis B, or Hepatitis C status; unknown status requires negative test before enrollment
  • Maternal medical conditions contraindicating surgery or anesthesia
  • Lack of health insurance covering routine prenatal care and related procedures (except fetal cystoscopy)
  • Inability to comply with travel and follow-up requirements
  • Participation in another intervention study affecting maternal or fetal outcomes or prior participation in this trial during a previous pregnancy
  • Declining invasive testing
  • Family not meeting psychosocial criteria including insufficient support

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

Terminated

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Research Team

R

Rodrigo A Ruano, MD, PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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