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ISRCTN
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ISRCTN33477809
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ClinicalTrials.gov identifier
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Public title
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Epidural related maternal temperature and neonatal outcome: a randomised controlled study
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0060148249
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Study hypothesis
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Maintaining normothermia during labour (including prevention of hyperthermia) will improve outcome in relation to:
1. Short term outcome:
1.1. Obstetric interventions - FBS, emergency caesarean section, instrumental delivery
1.2. Neonatal outcome - neonatal tone and neurobehaviour, neonatal encephalopathy, neonatal sepsis work up and antibiotic treatment, free oxygen radical induced cellular injury
2. Long term outcome - score on Griffiths mental developmental scales at 1 year
Please note that as of 27/06/2008, this record was updated to reflect that this trial was proposed but never started.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Single blind interventional randomised controlled trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Pregnancy and Childbirth: Labour
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Participants - inclusion criteria
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400 women in each group
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2003
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Anticipated end date
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01/11/2004
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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800
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Interventions
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Maintaining normothermia during labour versus care as usual.
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Primary outcome measure(s)
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Differences in mean NACS score at 24 +/- 6 hours between the intervention and control group
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Secondary outcome measure(s)
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1. Differences in emergency caesarean and instrumental deliveries
2. Foetal intervention - FBS
3. Neonatal adverse outcomes - resuscitation requirements, Apgar score at 1 and 5 minutes, cord gases, feeding difficulties, encephalopathy
4. Neonatal intervention rate with sepsis evaluation and antibiotic treatment
5. Measurement of free oxygen radical metabolites (e.g. malonildehyde) as marker of lipid peroxidation in cord blood
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Sources of funding
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1. Chelsea and Westminster Healthcare NHS Trust (UK)
2. NHS R&D Support Funding (UK)
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Trial website
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Publications
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Contact name
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Prof
Philip
Steer
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Address
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Dept of Obstetrics & Gynaecology
Chelsea & Westminster Hospial
369 Fulham Road
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City/town
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London
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Zip/Postcode
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SW10 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 8846 7892
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Fax
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+44 (0)20 8846 7880
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Email
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p.steer@imperial.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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21/04/2011
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Date ISRCTN assigned
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30/09/2005
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