Fetal Cystoscopy for Lower Urinary Tract Obstruction

Stopped early · Not applicable

Conditions studied: Urethral Obstruction

In brief

This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and to compare to the investigators clinical experience with fetal vesicoamniotic shunting.

Key facts

Study ID

NCT02446184

Run by

Baylor College of Medicine

People needed

8

Starts

2014-12-04

Expected to finish

2016-08-23

Last updated by the study team

2017-02-13

Who can join

Age: 0 and older, up to 1. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
• Oligohydramnios or Anhydramnios after 18 weeks
• "Favorable urine analysis after 18 weeks (urinary sodium is < 100mEq/L, chloride < 90mEq/L, osmolarity <200mOsm/L and β2-microglobulin <6mg/L 7)
• Absence of chromosomal abnormalities and associated anomalies (Normal karyotype by invasive testing (amniocentesis or CVS))
• Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks

You may not qualify if…

• Fetal anomaly unrelated to LUTO
• Congenital cardiac anomaly
• 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 - A body-mass index ≥ 35
• 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 a support person (ie. Spouse, partner, mother) available to support the patient for the duration of the pregnancy at Texas Children's Hospital/Ronald McDonald House
• Patient does not have healthy insurance to cover routine clinical care at Texas Children's Hospital 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 the 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.

Where it is running

• Texas Children's Hospital Pavilion for Women — Houston, Texas, United States

Full record on ClinicalTrials.gov

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