Condition category
Pregnancy and Childbirth
Date applied
21/10/2009
Date assigned
11/11/2009
Last edited
05/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.chelwest.nhs.uk/

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

Publication citations

Additional files

Editorial Notes