Sponsor study identifier
Secondary identifiers
OTHER · CAPPesq
interventional
60
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
There are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the effectiveness of these treatment, specially comparing both techniques. The present study aims to investigate the effectiveness of these treatments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 9, 2012
Actual (reported)March 13, 2012
Actual (reported)June 2015
Date type not reportedThis date has not been verified as actual or estimated.
May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Perinatal survival rate
The primary outcome is survival from the treatment to the neonatal period (up to 28 days of life). Therefore, the objective is to evaluate the safety and effectiveness of both therapeutic options.
from fetal period to neonatal perid (up to 28 days after birth)
Neonatal renal function
Renal function will be evaluated by serum creatine and urinalysis in the neonates, as well as by micturating cystourethrography and postnatal cystoscopy after birth up to 28 days of life.
up to 28 days of life
Survival rate at 6 months
Up to 6 months of life
Renal function at 6 months of life
6 months of life
Survival rate at 1 year of age
1 year of age
Renal function at 1 year of age
1 year of age
In this arm, patients will be randomly selected to undergo vesico-amniotic shunting.
In this arm, all patients will be randomly selected for fetal cystoscopy.
Fetal cystoscopy will be performed by introducing a 2.2mm sheath with 1.0mm fetoscope into fetal bladder under ultrasound guidance. The fetoscope will be advanced and the posterior urethral valves will be coagulated by ND:YAG laser. If urethra atresia was diagnosed, a vesico-amniotic shunting will be placed. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-010, Brazil
Ruano R, Pimenta EJ, Duarte S, Zugaib M. Four-dimensional ultrasonographic imaging of fetal lower urinary tract obstruction and guidance of percutaneous cystoscopy. Ultrasound Obstet Gynecol. 2009 Feb;33(2):250-2. doi: 10.1002/uog.6292. No abstract available.
Ruano R, Duarte S, Bunduki V, Giron AM, Srougi M, Zugaib M. Fetal cystoscopy for severe lower urinary tract obstruction--initial experience of a single center. Prenat Diagn. 2010 Jan;30(1):30-9. doi: 10.1002/pd.2418.
Rodrigo Ruano, MD, PhD
Faculdade de Medicina da Universidade de Sao Paulo
First Submitted
March 9, 2012
First Posted
March 13, 2012
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Estimated (date passed)In this arm, all patients randomly selected for this treatment will undergo vesico-amniotic shunting under ultrasound guidance. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Ruano R, Yoshisaki CT, Salustiano EM, Giron AM, Srougi M, Zugaib M. Early fetal cystoscopy for first-trimester severe megacystis. Ultrasound Obstet Gynecol. 2011 Jun;37(6):696-701. doi: 10.1002/uog.8963.
Morris RK, Ruano R, Kilby MD. Effectiveness of fetal cystoscopy as a diagnostic and therapeutic intervention for lower urinary tract obstruction: a systematic review. Ultrasound Obstet Gynecol. 2011 Jun;37(6):629-37. doi: 10.1002/uog.8981. Epub 2011 May 16.
Ruano R. Fetal surgery for severe lower urinary tract obstruction. Prenat Diagn. 2011 Jul;31(7):667-74. doi: 10.1002/pd.2736. Epub 2011 Mar 17.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 12, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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