title: PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.
abstract: OBJECTIVE
  The primary objective is to determine whether intrauterine vesicoamniotic shunting for fetal bladder outflow obstruction, compared with conservative, noninterventional care, improves prenatal and perinatal mortality and renal function. The secondary objectives are to determine if shunting for fetal bladder outflow obstruction improves perinatal morbidity, to determine if improvement in outcomes is related to prognostic assessment at diagnosis and, if possible, derive a prognostic risk index and to determine the safety and long-term efficacy of shunting.
  
  
  METHODS
  A multicentre randomised controlled trial (RCT).
  
  
  METHODS
  Fetal medicine units.
  
  
  METHODS
  Pregnant women with singleton, male fetus with isolated lower urinary tract obstruction (LUTO).
  
  
  METHODS
  Following ultrasound diagnosis of LUTO in a male fetus and exclusion of other structural and chromosomal anomalies, participation in the trial will be discussed with the mother and written information given. Consent for participation in the trial will be taken and the mother randomised via the internet to either insertion of a vesicoamniotic shunt or expectant management. During pregnancy, both groups will be followed with regular ultrasound scans looking at viability, renal measurements and amniotic fluid volume. Following delivery, babies will be followed up by paediatric nephrologists/urologists at 4-6 weeks, 12 months and 3 and 5 years to assess renal function via serum creatinine, renal ultrasound and need for dialysis/transplant.
  
  
  METHODS
  The main outcome measures will be perinatal mortality rates and renal function at 4-6 weeks and 12 months measured via serum creatinine, renal ultrasound and need for dialysis/transplant.
  
  
  BACKGROUND
  Wellbeing of Women. ESTIMATED COMPLETION DATE: September 2010. TRIAL ALGORITHM: [flowchart: see text].
authors.forename: Mark
authors.initials: M
authors.lastname: Kilby
authors.forename: Khalid
authors.initials: K
authors.lastname: Khan
authors.forename: Katie
authors.initials: K
authors.lastname: Morris
authors.forename: Jane
authors.initials: J
authors.lastname: Daniels
authors.forename: Richard
authors.initials: R
authors.lastname: Gray
authors.forename: Laura
authors.initials: L
authors.lastname: Magill
authors.forename: Bill
authors.initials: B
authors.lastname: Martin
authors.forename: Peter
authors.initials: P
authors.lastname: Thompson
authors.forename: Zarko
authors.initials: Z
authors.lastname: Alfirevic
authors.forename: Simon
authors.initials: S
authors.lastname: Kenny
authors.forename: Sarah
authors.initials: S
authors.lastname: Bower
authors.forename: Stephen
authors.initials: S
authors.lastname: Sturgiss
authors.forename: Dilly
authors.initials: D
authors.lastname: Anumba
authors.forename: Gerald
authors.initials: G
authors.lastname: Mason
authors.forename: Graham
authors.initials: G
authors.lastname: Tydeman
authors.forename: Peter
authors.initials: P
authors.lastname: Soothill
authors.forename: Karen
authors.initials: K
authors.lastname: Brackley
authors.forename: Pamela
authors.initials: P
authors.lastname: Loughna
authors.forename: Alan
authors.initials: A
authors.lastname: Cameron
authors.forename: Sailesh
authors.initials: S
authors.lastname: Kumar
authors.forename: Phil
authors.initials: P
authors.lastname: Bullen
mesh_terms: D005260:Female; D005315:Fetal Diseases / Q000601:surgery*; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D007674:Kidney Diseases / Q000209:etiology; D008297:Male; D011247:Pregnancy; D011295:Prenatal Care / Q000379:methods*; D016896:Treatment Outcome; D001748:Urinary Bladder Neck Obstruction / Q000196:embryology / Q000601:surgery*