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ISRCTN
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ISRCTN33931714
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ClinicalTrials.gov identifier
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Public title
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Peri-operative fluid warming in elective caesarean section
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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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N0060187568
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Study hypothesis
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Does providing warmed intravenous fluid at elective caesarean section reduce the incidence of hypothermia and improve maternal thermal comfort?
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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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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: Caesarean section
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Participants - inclusion criteria
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Healthy women with uncomplicated single pregnancy of > 37 weeks’ gestation due for elective caesarean section
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Participants - exclusion criteria
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1. Pyrexia
2. Inability to take non-steroidal anti-inflammatory (NSAIDs) medication
3. Pre-eclampsia/eclampsia
4. Drug therapy other than antacids and vitamins/minerals
5. Increased risk of intra-operative haemorrhage (eg placenta praevia or accreta).
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Anticipated start date
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25/10/2006
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Anticipated end date
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01/12/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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75 to be recruited consecutively
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Interventions
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Warmed intravenous fluid vs no warmed intravenous fluid
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Primary outcome measure(s)
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Core body temperature, incidence and severity of shivering and pain (Visual Analogue Scale), thermal comfort score (visual analogue scale), fetal Apgar scores and umbilical cord blood gas measurements (routinely performed at caesarean section)
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Secondary outcome measure(s)
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1. Shivering
2. Self-reported thermal comfort
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Sources of funding
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Chelsea and Westminster Healthcare NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Steve
Yentis
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Address
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Magill Dept of Anaesthesia, Intensive Care & Pain Management
Chelsea and Westminster Hospital
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 8746 8026
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Fax
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+44 (0)20 8746 8801
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Email
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s.yentis@imperial.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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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
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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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28/09/2007
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Last edited
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05/09/2008
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Date ISRCTN assigned
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28/09/2007
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