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Prenatal treatment of Lower Urinary Tract Obstruction
ISRCTN ISRCTN53328556
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

Foetus:
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
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