RecruitingNot ApplicableNCT03281798

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

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

Sponsor

Rodrigo Ruano

Enrollment

10 participants

Start Date

Jan 1, 2018

Study Type

INTERVENTIONAL

Conditions

Bladder Outlet Obstruction Lower Urinary Tract Obstructive Syndrome Lower Urinary Tract Obstruction, Congenital Bladder Outflow Obstruction

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

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.

Exclusion Criteria15

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
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
Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Maternal medical condition that is a contraindication to surgery or anesthesia
Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.
Inability to comply with travel and follow-up requirements of the trial
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Patients declining invasive testing
Family does not meet psychosocial criteria including insufficient

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Interventions

DEVICEFetoscopes

Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.

PROCEDUREFetal Cystoscopy

A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.

Locations(2)

University of Miami

Miami, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

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NCT03281798

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