PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial.
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].
Kilby
Mark
M
Khan
Khalid
K
Morris
Katie
K
Daniels
Jane
J
Gray
Richard
R
Magill
Laura
L
Martin
Bill
B
Thompson
Peter
P
Alfirevic
Zarko
Z
Kenny
Simon
S
Bower
Sarah
S
Sturgiss
Stephen
S
Anumba
Dilly
D
Mason
Gerald
G
Tydeman
Graham
G
Soothill
Peter
P
Brackley
Karen
K
Loughna
Pamela
P
Cameron
Alan
A
Kumar
Sailesh
S
Bullen
Phil
P
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*