ELIGIBILITY

• Written informed consent given
• Able to understand information provided (use of interpreter may be required)
• Singleton pregnancy
• Evidence of bladder outflow obstruction from ultrasound imaging
• Randomisation is based largely on the “uncertainty principle”.  That is, if there is a definite indication for or contraindication against shunting then the fetus is not eligible for randomisation.  If, however, there is substantial uncertainty as to whether or not shunting is indicated, the fetus is eligible to be randomised.

TELEPHONE RANDOMISATION

• Obtain mother's consent for randomisation or registration
• Prepare for telephone questions using the randomisation/ registry notepad - all questions will need to be answered
• Go to web page or telephone the randomisation service on 0800 953 0274
• When all the relevant questions on the randomisation notepad have been answered, a treatment allocation will be given for randomised fetuses. The PLUTO trial number will also be allocated.

TREATMENT

• If allocated to shunt, this should be inserted as soon as possible
• The fetus should continue to be monitored every 4 weeks and important prognostic data collected on the Prenatal Assessment Form

FOLLOW-UP

• The outcome of the pregnancy and any adverse events are collected spontaneously
• Perinatal mortality and renal function are the primary outcome measures
• Follow-up at 12 months will be undertaken by a paediatric nephrologist

FOR RANDOMISATION

Go to www.trials.bham.ac.uk/PLUTO or call 0800 953 0274 or fax 0121 414 9136

 For administrative queries and trial supplies, please contact:

PLUTO Trial Office,
Tel: 0121 414 9011  Email: pluto-trial@contacts.bham.ac.uk