Support Centre
30 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Prenatal treatment of Lower Urinary Tract Obstruction
DOI 10.1186/ISRCTN53328556
ClinicalTrials.gov identifier
EudraCT number
Public title Prenatal treatment of Lower Urinary Tract Obstruction
Scientific title A multi-centre randomised controlled trial comparing intra-uterine vesico-amniotic shunting versus not shunting in the treatment of congenital bladder outflow obstruction
Acronym PLUTO
Serial number at source HTA 07/01/44; NN3007
Study hypothesis Does intra-uterine vesico-amniotic shunting for fetal bladder outflow obstruction improve perinatal morbidity and mortality in fetuses, compared to conservative management?

Protocol in: http://www.hta.ac.uk/protocols/200700010044.pdf
HTA record URL: http://www.hta.ac.uk/1732

Please note that as of 11/02/2009 this record was updated to include an amended anticipated end date. The initial anticipated end date was 30/09/2010.
Lay summary Not provided at time of registration
Ethics approval Added 11/02/2009: Nottingham Research Ethics Committee 2 gave approval in January 2005 (ref: 04/Q2404/89)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Congenital bladder outflow obstruction
Participants - inclusion criteria Mother:
1. Written informed consent given
2. Able to understand information provided (use of interpreter may be required)
3. Singleton pregnancy

1. Evidence of bladder outflow obstruction from ultrasound imaging
2. No major extra genitourinary anomalies present
Participants - exclusion criteria Additional major structural or chromosomal anomaly
Anticipated start date 01/09/2005
Anticipated end date 30/09/2018
Status of trial Ongoing
Patient information material Patient information material can be found at http://www.pluto.bham.ac.uk/trial/Patient.htm.
Target number of participants 200
Interventions Fetal vesico-amniotic shunt versus no shunt.
Primary outcome measure(s) Perinatal mortality rates and renal function at 4 - 6 weeks and 12 months measured via:
1. Serum creatinine
2. Renal ultrasound
3. Need for dialysis/transplant
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Added on 11/02/2009 (initiated in September 2008):
NIHR Health Technology Assessment Programme - HTA (UK)

Initial funding at time of registration:
Wellbeing of Women (UK)
Trial website http://www.pluto.bham.ac.uk/
Publications 2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17567421
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23953766
Contact name Prof  Mark  Kilby
  Address University of Birmingham
Department of Fetal Medicine
Birmingham Women's Hospital
Metchley Park Road
  City/town Birmingham
  Zip/Postcode B15 2TG
  Country United Kingdom
  Tel +44 (0)121 627 2778
  Fax +44 (0)121 415 4837
  Email m.d.kilby@bham.ac.uk
Sponsor University of Birmingham (UK)
  Address Edgbaston
  City/town Birmingham
  Zip/Postcode B15 2TT
  Country United Kingdom
  Email b.l.laverty@bham.ac.uk
  Sponsor website: http://www.bham.ac.uk/
Date applied 28/04/2005
Last edited 22/08/2013
Date ISRCTN assigned 21/09/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.