EPIFEVER-2

• Research type

  Research Study

• Full title

  EPIdural FEVER-2: Epidural-related maternal fever: personalised genomic medicine to guide labour analgesia.

• IRAS ID

  270480

• Contact name

  Gareth Ackland

• Contact email

  g.ackland@qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• Duration of Study in the UK

  2 years, 4 months, 1 days

• Research summary

  Fever develops in up to 20% of women who request epidurals for pain killing during childbirth. This may occur because the drug used in epidurals to numb nerves and ease pain may also affect a protein called interleukin-1 receptor antagonist that normally helps reduce the chances of developing fever. Lower levels of interleukin-1 receptor antagonist may increase the risk of women developing fever and/or receiving antibiotics during childbirth.

  Interleukin-1 receptor antagonist levels are genetically determined, with around 1 in 5 women having lower levels. In this study, we want to see whether women with genetically programmed lower levels of Interleukin-1 receptor antagonist are more likely to develop fever after having epidural pain relief during childbirth.

  Lay summary of study results:
  Genetically higher levels of the anti-inflammatory cytokine interleukin-1 receptor antagonist (IL-1ra) are not associated with lower Caesarean births after epidural analgesia, in contrast to non-epidural analgesia. We hypothesized that epdiural pain relief increases the risk of needing a Caesarean birth (C-section) by increasing the frequency of epidural fever in women with genetically higher levels of IL-1ra.
  155/624 (24.8%) women (mean age 32y; 45% non-white) developed epidural fever and/or received antibiotics during their labour. 71/155 (48.4%) women with epidural fever/antibiotics required Caesarean birth, compared to 143/469 (30.5%) with no epidural fever/antibiotics (odds ratio (OR):1.93 (95%CI:1.38-2.80); P<0.001). 19/74 (25.7%) women with zero allele score had intrapartum fever/antibiotics, compared with 136/550 (24.7%) women with allele scores ≥1 (OR:1.05 (95%CI:0.60-1.83); P=0.89). Women with allele scores ≥1 and epidural fever/antibiotics had 4.1h (95%CI:2.8-5.3) longer labour. Caesarean births were more frequent in 61/136 (44.9%) women with allele scores ≥1 and epidural fever/antibiotics, compared to 122/414 (29.5%) without epidural fever/antibiotics (OR:1.95 (95%CI:1.31-2.09); P<0.001). For women with zero allele scores, epidural fever/antibiotics were not associated with a higher Caesarean birth rate (OR:0.56 (95%CI:0.19-1.59); P=0.27).
  In women with genetically determined higher IL-1Ra levels, epidural analgesia disrupts IL-1Ra-mediated anti-inflammatory mechanisms, prolongs labour and increases

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  20/LO/1213

• Date of REC Opinion

  17 Nov 2020

• REC opinion

  Favourable Opinion