EPIFEVER: elucidating molecular mechanisms underlying epidural-related maternal fever

ISRCTN ISRCTN11281491
DOI https://doi.org/10.1186/ISRCTN11281491
Secondary identifying numbers Protocol v1.2
Submission date
24/11/2014
Registration date
28/01/2015
Last edited
03/07/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
About a third of women in labour receive pain relief via an epidural. When an epidural is performed by an anaesthetic doctor, the anaesthetist places a small plastic tube into a space in the back through which local anaesthetic is infused. A quarter of women who have an epidural in labour develop a high temperature or fever, known as epidural-related maternal fever, but doctors currently do not understand why the fever occurs. Fever during labour can be a real problem. The high temperature results in a more stressful labour for mother and baby. Midwives and obstetricians looking after mothers in labour with a high temperature are concerned that the fever might be due to infection, and these mothers commonly receive antibiotics. It is clear that many women who have an epidural-related maternal fever do not have infection and so the antibiotic treatment is unnecessary. Finally a fever in labour can sometimes lead to women having a Caesarean section or instrumental deliveries because of concerns about the baby. The aim of this study is to find the cause of epidural-related maternal fever. If we can find the cause, we hope to then be able to develop a way to prevent it from happening, and also avoid the use of unnecessary antibiotics.

Who can participate?
We are approaching pregnant women who may receive an epidural for pain relief in labour or for delivery, and non-pregnant women having an epidural for surgery.

What does the study involve?
It is well known that local anaesthetics not only reduce pain, but may also cause immune cells to release substances into the mother’s bloodstream. We believe that these substances may be the cause of the fever. We will investigate whether the local anaesthetic causes fever by testing its effects on immune cells collected in blood samples. We would like to collect blood from two groups of women in labour: those receiving an epidural for pain relief and those who do not receive an epidural. We will also collect blood samples from non-pregnant women having surgery who also receive an epidural, so we can find out how epidurals may affect immune cells in women who are not pregnant.

What are the possible benefits and risks of participating?
The information we get from this study may help us to better treat future patients undergoing epidurals for pain relief and anaesthesia and to prevent epidural-related maternal fever. Every procedure described is a routine part of your care, so there are no additional risks of taking part. We will try as far as possible to collect the blood samples from your existing drip access, which does not carry any risk. If this not possible and we need to collect a blood sample from a vein in your arm.

Where is the study run from?
University College London Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
October 2014 to March 2016

Who is funding the study?
Obstetrics Anaesthetists' Association (OAA)

Who is the main contact?
Dr Gareth Ackland
g.ackland@ucl.ac.uk

Contact information

Dr Gareth Ackland
Scientific

UCLH
235 Euston Road
London
NW1 2BU
United Kingdom

ORCiD logoORCID ID 0000-0003-0565-5164
Phone +44 (0)2076796683
Email g.ackland@ucl.ac.uk

Study information

Study designObservational single-centre study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEPIFEVER: elucidating molecular mechanisms underlying EPIdural-related maternal FEVER - an observational single-centre study
Study acronymEPIFEVER
Study objectivesInflammatory mechanisms associated with the development of fever following epidural analgesia started in established labour.
Ethics approval(s)NRES Committee South Central - Oxford A Bristol Research Ethics Committee Centre, 18/08/2014, REC ref: 14/SC/1160
Health condition(s) or problem(s) studiedEpidural-related maternal fever (ERMF)
InterventionLocal anaesthetics not only reduce pain but may also damage immune cells, resulting in substances being released into the mother’s bloodstream and causing fever. We will investigate whether the local anaesthetic causes fever through the release of fever-inducing substances by undertaking tests on immune cells obtained from two groups of women: those receiving an epidural for pain relief and those who do not use epidural analgesia. We will also use samples from surgical patients who also receive epidural analgesia. We will insert an IV drip into women/patients which is used routinely as part of their hospital stay, thereby minimizing unnecessary discomfort. While inserting the IV drip a tablespoon of blood will be taken for laboratory tests. 4 hours later another tablespoon of blood will be taken. We will then compare function of immune cells before and after epidural local anaesthetic has been administered. If local anaesthetic is found to affect immune function and be a cause of fever, these results will enable us to identify the cause of fever in individual women in labour and help avoid unnecessary clinical interventions and antibiotic administration in the future.
Intervention typeOther
Primary outcome measureDevelopment of maternal fever; temperature measured pre and 4 hours after onset of epidural analgesia.
Secondary outcome measuresLaboratory-based assays of immune function pre- and 4 hours post-epidural (or otherwise)
Overall study start date01/10/2014
Completion date31/03/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants144
Total final enrolment53
Key inclusion criteria>37 weeks gestation, established labour (≥ 2 cm dilated with contractions) and all babies delivered from these women will have outcomes follow up

For female surgical patients >18 years old, all those who have agreed to receive epidural analgesia decided in conjunction with their attending anaesthetist will be eligible
Key exclusion criteriaObstetric patients:
1. No pre-eclampsia or hypertensive disorder
2. No pre-existing immune dysfunction
3. No known infection
4. Not currently on antibiotics
5. Not received NSAID

Female surgical patients:
1. No known infection
2. Not currently on antibiotics
3. Not received NSAID
4. Not pregnant
Date of first enrolment01/10/2014
Date of final enrolment31/03/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UCLH NHS Trust
235 Euston Road
London
NW1 2BU
United Kingdom

Sponsor information

UCLH NHS Trust
Hospital/treatment centre

Joint Research Office
1st Floor Maple House, Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

Phone +44 (0)20 3447 9995
Email JRO.Communications@uclh.nhs.uk
Website www.ucl.ac.uk/jro
ROR logo "ROR" https://ror.org/042fqyp44

Funders

Funder type

Charity

Obstetrics Anaesthetists' Association (OAA)

No information available

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2019 03/07/2020 Yes No
HRA research summary 26/07/2023 No No

Editorial Notes

03/07/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
15/05/2018: No publications found, verifying study status with principal investigator.