Extrait

Background and study aims Fetal bladder outflow obstruction is a rare condition where an unborn baby (fetus) is unable to pass urine due to a blockage of the tube called the urethra. This may cause permanent damage to the baby's kidneys and can lead to poor lung development and physical deformities such as clubfoot. About half of the babies diagnosed with this problem before birth will die either before birth or in the newborn period. For several years, vesico-amniotic shunting has been offered as a treatment to relieve the obstruction. A vesico–amniotic shunt is a tube that it is inserted into the unborn baby’s bladder to drain the excess fluid. However, there is only weak evidence that it improves survival and kidney function in those treated. The aim of this study is to find out whether vesico-amniotic shunting improves outcomes for fetal bladder outflow obstruction. Who can participate? Fetuses with bladder outflow obstruction What does the study involve? Following an ultrasound diagnosis of fetal bladder outflow obstruction, the fetuses are randomly allocated to either receive a vesico-amniotic shunt or continue with conservative treatment without a shunt. Termination and miscarriage rates, survival, and bladder and kidney function are assessed at 4 - 6 weeks and 12 months, and continence is assessed at 5 years. What are the possible benefits and risks of participating? This study is a crucial step in establishing whether this procedure has a place in future fetal medicine practice. Where is the study run from? University of Birmingham (UK) When is the study starting and how long is it expected to run for? September 2005 to September 2018 Who is funding the study? NIHR Health Technology Assessment Programme (UK) Who is the main contact? Prof. Mark Kilby [email protected]

Critère d'inclusion

• Congenital bladder outflow obstruction

Liens

• ictrp
• isrctn