Plain English Summary

Not provided at time of registration

Trial website

http://www.pluto.bham.ac.uk/

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

http://www.bham.ac.uk/

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

  1. 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.

  2. 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.

Editorial Notes