PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial

Objectives 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. Design A multicentre randomised controlled trial (RCT). Setting Fetal medicine units. Population 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. Main outcome measures 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. Funding Wellbeing of Women. Estimated completion date September 2010. Trial algorithm Principal investigators from PLUTO trial sites with Local Research Ethics Committee and Research and Development approval to be named as co‐authors The PLUTO trial management group includes Prof Mark Kilby (chief investigator), Prof Khalid Khan, Dr Katie Morris, Jane Daniels, Prof Richard Gray and Laura Magill.At the time of submitting this protocol, the following clinicians have obtained approval for randomisation: Prof Mark Kilby, Prof Khalid Khan, Mr Bill Martin and Mr Peter Thompson—Birmingham Women’s Hospital NHS Trust;Prof Zarko Alfirevic—Liverpool Women’s Hospital NHS Trust;Mr Simon Kenny—Royal Liverpool Children’s NHS Trust;Dr Sarah Bower—King’s College Hospi