Investigating how genetic differences relate to the risk of maternal fever due to epidural pain relief in mothers during labour
| ISRCTN | ISRCTN99641204 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99641204 |
| IRAS number | 270480 |
| Secondary identifying numbers | IRAS 270480, version 1.0 |
- Submission date
- 26/04/2021
- Registration date
- 29/04/2021
- Last edited
- 09/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The project aims to identify women who may be genetically programmed to be more likely to have a fever if they choose epidural (an injection into the back) during labour. By identifying this group of women, we may be able to make their labours more comfortable and less stressful by knowing that they have a higher chance of developing a fever.
Who can participate?
Pregnant women aged over 18 years who request an epidural for labour pain relief
What does the study involve?
Participants will consent to providing a small, single blood sample (as part of the routine blood draw required at the time of the epidural) for genetic analysis. The relationship between one gene that may increase the risk of fever after epidurals and the development of fever and/or prescription of antibiotics plus the outcome of the baby will be recorded.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participating in this study.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
From March 2020 to December 2023
Who is funding the study?
The National Institute for Academic Anaesthesia (UK) and the Obstetric Anaesthetists' Association (UK)
Who is the main contact?
Prof Gareth Ackland
g.ackland@qmul.ac.uk
Contact information
Scientific
Translational Medicine & Therapeutics (218A)
William Harvey Research Institute
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
John Vane Science Centre
Charterhouse Square
London
EC1M 6BQ
United Kingdom
 ORCID ID |
0000-0003-0565-5164 |
|---|---|
| Phone | +44 (0)2078822100 |
| g.ackland@qmul.ac.uk |
Study information
| Study design | Mendelian randomization study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Available from http://qmul.ac.uk/ccpmg/ |
| Scientific title | EPIFEVER-2: Mendelian randomisation study of polymorphisms in interleukin-1 receptor antagonist and epidural-related maternal fever. |
| Study acronym | EPIFEVER-2 |
| Study objectives | Polymorphisms in the interleukin-1 receptor antagonist gene promote fever in labouring women receiving epidural analgesia. |
| Ethics approval(s) | Approved 25/01/2021, London – Bloomsbury Research Ethics Committee (MSE Meeting Rooms, Tottenham Court Road, London, W1T 1BB; +44 (0)207 104 8063; bloomsbury.rec@hra.nhs.uk), ref: 20/LO/1213 |
| Health condition(s) or problem(s) studied | Epidural-related maternal fever in active labour |
| Intervention | Women are enrolled either in antenatal clinic or on admission to labour ward. A single blood sample is obtained around the time of epidural insertion. Clinical outcomes are collected for the duration of their hospital stay. |
| Intervention type | Other |
| Primary outcome measure | The incidence of one or both of the following: 1. Maternal temperature >38°C (triggered by RCOG guidelines for two temperatures >37.5°C) recorded as part of their standard care from patient notes at least 4h after epidural analgesia is commenced 2. Prescription of antibiotics during labour before delivery measured from patient notes before delivery |
| Secondary outcome measures | Clinical outcomes for mother and baby measured from patient notes during their hospital stay |
| Overall study start date | 01/03/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 637 |
| Total final enrolment | 632 |
| Key inclusion criteria | 1. Aged ≥18 years old 2. Singleton or twin pregnancy 3. Any gestational age 4. Requesting an epidural for labour analgesia |
| Key exclusion criteria | 1. Unwilling or unable to give consent 2. Refusal of consent for competent participants 3. Inability to understand written and/ or verbal English 4. Immune/genetic syndromes/mutations 5. Microbiologically proven infection prior to epidural insertion 6. Established pyrexia 7. Intrauterine death |
| Date of first enrolment | 28/04/2021 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
E1 1FR
United Kingdom
London
E9 6SR
United Kingdom
London
NW1 2BU
United Kingdom
Sheffield
S5 7AU
United Kingdom
Sponsor information
University/education
Empire House
67-75 New Road
London
E1 1HH
England
United Kingdom
| Phone | +44 (020) 7882 7275 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.qmul.ac.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Research organisation
Private sector organisation / Universities (academic only)
- Alternative name(s)
- NIAA
- Location
- United Kingdom
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- OAA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol and statistical analysis plan will be made publicly accessible on the Queen Mary University of London website http://www.qmul.ac.uk/. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 01/05/2022 | 12/08/2024 | Yes | No | |
| Results article | 14/05/2025 | 09/06/2025 | Yes | No |
Editorial Notes
12/08/2024: Publication reference and total final enrolment were added.
12/05/2021: Internal review.
29/04/2021: Trial’s existence confirmed by HRA and Health and Care Research Wales (HCRW).
