Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mark Kilby
ORCID ID
Contact details
University of Birmingham
Department of Fetal Medicine
Birmingham Women's Hospital
Metchley Park Road
Birmingham
B15 2TG
United Kingdom
+44 (0)121 627 2778
m.d.kilby@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/01/44; NN3007
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information material can be found at http://www.pluto.bham.ac.uk/trial/Patient.htm.
Condition
Congenital bladder outflow obstruction
Intervention
Fetal vesico-amniotic shunt versus no shunt.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
Not provided at time of registration
Overall trial start date
01/09/2005
Overall trial end date
30/09/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
200
Participant exclusion criteria
Additional major structural or chromosomal anomaly
Recruitment start date
01/09/2005
Recruitment end date
30/09/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
b.l.laverty@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Added on 11/02/2009 (initiated in September 2008):
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Initial funding at time of registration:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wellbeing of Women (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17567421
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23953766
Publication citations
-
Protocol
, Kilby M, Khan K, Morris K, Daniels J, Gray R, Magill L, Martin B, Thompson P, Alfirevic Z, Kenny S, Bower S, Sturgiss S, Anumba D, Mason G, Tydeman G, Soothill P, Brackley K, Loughna P, Cameron A, Kumar S, Bullen P, PLUTO trial protocol: percutaneous shunting for lower urinary tract obstruction randomised controlled trial., BJOG, 2007, 114, 7, 904-5, e1-4, doi: 10.1111/j.1471-0528.2007.01382.x.
-
Results
Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Hemming K, Burke D, Daniels JP, Khan KS, Deeks J, Kilby MD, , Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial., Lancet, 2013, 382, 9903, 1496-1506, doi: 10.1016/S0140-6736(13)60992-7.