Contact information
Type
Scientific
Primary contact
Dr Steve Yentis
ORCID ID
Contact details
Magill Dept of Anaesthesia
Intensive Care & Pain Management
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 (0)20 8746 8026
s.yentis@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0060187568
Study information
Scientific title
Acronym
Study hypothesis
Does providing warmed intravenous fluid at elective caesarean section reduce the incidence of hypothermia and improve maternal thermal comfort?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pregnancy and Childbirth: Caesarean section
Intervention
Warmed intravenous fluid vs no warmed intravenous fluid
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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)
Secondary outcome measures
1. Shivering
2. Self-reported thermal comfort
Overall trial start date
25/10/2006
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy women with uncomplicated single pregnancy of > 37 weeks gestation due for elective caesarean section
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
75 to be recruited consecutively
Participant exclusion criteria
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).
Recruitment start date
25/10/2006
Recruitment end date
01/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Magill Dept of Anaesthesia, Intensive Care & Pain Management
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chelsea and Westminster Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19665366
Publication citations
-
Results
Woolnough M, Allam J, Hemingway C, Cox M, Yentis SM, Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial., Int J Obstet Anesth, 2009, 18, 4, 346-351, doi: 10.1016/j.ijoa.2009.02.009.