Clinical Trial: Fetal Cystoscopy for Lower Urinary Tract Obstruction
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction - a Prospective Trial
Brief Summary: 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.
Detailed Summary:
Patients with severe LUTO will come for clinical evaluation as part of the standard clinical care at the Fetal Center at Texas Children's Hospital. Once the diagnosis of fetal severe LUTO is confirmed and the patient is considered for fetal intervention, patient will be invited to participate in the present study. Fetal cystoscopy will be offered as an optional experimental procedure.
The following information will be obtained in the standard clinical care visit as usual: a. demographics (maternal age, parity); b. gestational age at the diagnosis of LUTO; c. fetal ultrasound findings including documentation of cervical length, gestational age,fetal bladder size, bladder wall thickness, degree of fetal hydronephrosis, amount of amniotic fluid, fetal biometry; d. fetal urinary biochemistry; e. fetal echocardiogram findings.
The standard management options for fetal LUTO include expectant management, fetal vesico-amniotic shunting or termination of pregnancy according to the law. These options will be offered to all patients as the first set of management options and the gold standard. In addition, the investigators group will offer the procedure as an alternative experimental option, with a full explanation of the experimental nature of the procedure, the technical benefits and difficulties, and the risks and potential benefits of the procedure and the limited long-term outcomes information. Those patients who request participation in the present study will be informed that they can, a priori, select a crossover arm if for any reason the fetal cystoscopic procedure is not possible. They can elect that a fetal vesico-amniotic shunting be performed or prenatal expectant management or even termination of pregnancy (as part of the standard management of fetuses with LUTO).
Partic
Sponsor: Baylor College of Medicine
Current Primary Outcome: Postnatal survival at 2 years of life [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Postnatal renal function at 2 years of life [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Baylor College of Medicine
Dates:
Date Received: May 12, 2015
Date Started: December 4, 2014
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017
