Plain English Summary
Background and study aims
Epidural anaesthesia, often referred to as an epidural, is an injection in the lower back that numbs the nerves and stops mothers from feeling pain during childbirth. It has been known for 25 years that the use of epidural anaesthesia during labour greatly increases the likelihood of a woman developing a high temperature (pyrexia). Pyrexia in labour is associated with brain conditions including neonatal encephalopathy, and in the long term, cerebral palsy. In addition, it is known to increase the proportion of babies admitted to neonatal units for sepsis workup and antibiotic treatment. However, few admissions turn out to be due to infection. Our current theory is that the mother feels cold in the lower half of her body which is anaesthetised, and this causes part of the brain called the hypothalamus to increase her temperature. Studies have suggested that warming the blood going to the hypothalamus by wearing a neck warmer helps to prevent this increase in temperature. The aim of this study is to test whether wearing a neck warmer reduces the maternal temperature rise associated with epidural analgesia in labour.
Who can participate?
Women treated with epidurals for analgesia in labour.
What does the study involve?
Participating women will be randomly allocated to wear a neck collar that is either warmed or left at room temperature. Their temperature will be taken every 4 hours, and the outcome of the labour will be recorded.
What are the possible benefits and risks of participating?
The potential benefit is that mothers allocated to wear a neck warmer may not develop pyrexia, thus avoiding complications for her and her baby. There are no known risks of wearing the neck collar of itself, and when warmed, the neck collar is only 41°C, so there are no anticipated harmful effects.
Where is the study run from?
Chelsea and Westminster Hospital (UK).
When is the study starting and how long is it expected to run for?
The study ran from June 2009 to August 2011.
Who is funding the study?
Chelsea and Westminster Hospital (UK).
Who is the main contact?
Prof Philip Steer
p.steer@imperial.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Philip Steer
ORCID ID
Contact details
Academic Obstetric Department
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 (0)2088467892
p.steer@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WOG09002CN
Study information
Scientific title
A randomised clinical trial of the paradoxical cooling effect of a neck warmer in the prevention of maternal pyrexia after insertion and management of low dose epidurals in labour
Acronym
Study hypothesis
Wearing a neck warmer will paradoxically reduce the maternal temperature rise associated with epidural analgesia in labour.
Ethics approval
Riverside Research Ethics Committee, Charing Cross Hospital, 05/12/2008, ref: 08/H0706/105
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Fever in women with epidural analgesia during labour
Intervention
Intervention group: Neck warmer worn during labour
Control group: No intervention
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Maternal temperature rise during labour
Secondary outcome measures
1. Neonatal temperature at 15 minutes post delivery
2. Change in baseline foetal heart rate on cardiotocography (CTG) from the time that the epidural was sited until delivery
3. Apgar scores at 1 and 5 minutes
4. Percentage of neonates admitted to the Neonatal Intensive Care Unit
5. Number of hours of maternal shivering during labour
6. Percentage of women given paracetamol for fever in labour
7. Mode of delivery
8. Rise in inflammatory markers (IL-6 and C-reactive protein [CRP])
Overall trial start date
08/06/2009
Overall trial end date
01/08/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women (no age limit) with epidurals for analgesia in labour
2. Nulliparous women (more likely to have labours >6 hours)
3. Cervical dilatation no more than 4 cm (more likely to have labours >6 hours)
4. First labour (more likely to have labours >6 hours)
5. Gestation >36 weeks (more likely to have labours > 6 hours)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Participant exclusion criteria
1. Pre-existing fever >37.5 degrees C (fever caused by something other than the epidural)
2. Concurrent maternal disease, including pre-eclampsia (pro-inflammatory state)
3. Multiple pregnancy (physiology of labour exaggerated)
4. Patients receiving steroids or non-steroidal anti-inflammatory drugs within 6 hours (may influence the temperature and interleukin 6 [IL-6])
Recruitment start date
08/06/2009
Recruitment end date
01/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Obstetric Department
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Chelsea and Westminster NHS Foundation Trust (UK)
Sponsor details
Chelsea and Westminster R&D Department
369 Fulham Road
London
SW10 9NH
United Kingdom
-
christopher.braime@chelwest.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Joint Research Committee grant, Chelsea & Westminster Hospital (UK) (ref: 08/09 SG 015)
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
Results - basic reporting
Publication summary