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Prevention and management of hypothermia and shivering

Caesarean birth

Evidence review C

NICE Guideline, No. 192

Authors

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London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4052-3
Copyright © NICE 2021.

Hypothermia and shivering

Review question

What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

Introduction

Hypothermia and shivering may be seen in people undergoing surgery and may be due to physical causes, such as exposure of skin in a cool operating theatre, the effects of certain anaesthetic agents, and to the release of stress hormones such as adrenaline. Shivering increases oxygen consumption and therefore may increase the risk of cardiac complications, while hypothermia may adversely affect blood clotting and wound healing. In addition, shivering also has practical consequences, as it makes it difficult to monitor blood pressure using non-invasive methods such as oscillometric blood pressure monitors.

Complications due to hypothermia are more of a problem for the elderly, and people with pre-existing cardiac disease, while the majority of the population of women having a caesarean birth are young and healthy. There is little evidence of adverse morbidity for mothers and babies due to hypothermia and shivering, but it is known to be unpleasant and may reduce the quality of the birth experience.

The aim of this review is to identify what procedures can be used to prevent and manage hypothermia and shivering in women having a caesarean birth.

Summary of the protocol

Please see Table 1 for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.

For further details, see the review protocol in appendix A.

Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual (2014). Methods specific to this review question are described in the review protocol in appendix A.

Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).

Clinical evidence
Included studies

Twenty-three studies were included in this review. Twenty-one studies were patient level RCTs, and 2 were cluster RCTs (Duryea 2016, Grant 2015). Cluster RCTs were downgraded once for imprecision as they provided insufficient information available for design effect adjustment. One study examined management of shivering (only intervening with women who were shivering, Casey 1988), and 22 studies assessed prevention of shivering, with measures administered before or during caesarean birth (CB), whether women were shivering or not.

Data were grouped by the comparison of interest, and the intervention type:

ACTIVE WARMING MEASURES (TRANSFER HEAT TO PATIENT) versus CONTROL
1. Warmed IV fluids versus controlChan 1989; Chung 2012; Jorgensen 2000; Paris 2014; Smith 2000; Woolnough 2009; Workhoven 1986; Yokoyama 2009
2. FAW versus controlButwick 2007; Chebbout 2017; Chung 2012; Fallis 2006; Horn 2002; Horn 2014; Munday 2018
3. FAW + warmed IV fluids versus controlCobb 2016
4. Mattress warming versus controlChakladar 2014; Chebbout 2017; Paris 2014
ACTIVE WARMING MEASURES versus OTHER ACTIVE WARMING
5. FAW versus warmed IV fluidsChung 2012
6. FAW versus mattress warmingChebbout 2017
7. Mattress warming versus other warmingGrant 2015; Paris 2014
THERMAL INSULATION MEASURES
8. Higher (23oC) versus lower (20oC) ambient temperatureDuryea 2016
PHARMACOLOGICAL THERAPY
9. 5-HT3 antagonist versus controlBrowning 2013
10. Pethidine versus morphine (opioid versus opioid)Hong 2005
11a. Opioid versus control (prevention)Hong 2005; Roy 2004; Sutherland 1991
11b. Opioid versus control (management)Casey 1988

FAW: forced air warming; IV: intravenous

Studies were performed in women with a scheduled/elective/non-emergency caesarean birth, or included any caesarean birth:

See the literature search strategy in appendix B and study selection flow chart in appendix C.

Excluded studies

Studies not included in this review with reasons for their exclusions are provided in appendix K.

Summary of clinical studies included in the evidence review

A summary of the studies that were included in this review are presented in Table 2.

See the full evidence tables in appendix D and the forest plots in appendix E.

Quality assessment of clinical outcomes included in the evidence review

See the clinical evidence profiles (GRADE tables) in appendix F.

Economic evidence
Included studies

A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.

See the literature search strategy in appendix B.

Economic model

No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.

Evidence statements

When subgroups have been assessed, these statements are presented as bullet points below the main comparison

Active warming measures versus control
Comparison 1. Warmed IV fluids versus control
Critical outcomes
Incidence of hypothermia
  • Very low quality evidence from 2 RCTs (n=216) shows no clinically important difference in the incidence of hypothermia between the group who received warmed IV fluids and the control group.
Incidence of shivering
  • Low quality evidence from 6 RCTs (n=369) shows a clinically important difference between groups, with a lower incidence of shivering in the group who received warmed IV fluids compared to the control group.
    Subgroup analysis:
    • Very low quality evidence from 3 RCTs (n=255) shows no clinically important difference in the incidence of shivering between the group who received warmed IV fluids (maintained fluid warming 37–42°C) and the control group.
    • Very low quality evidence from 1 RCT (n=30) shows a clinically important difference in the incidence of shivering between the groups, with a lower incidence of shivering in the group who received warmed IV fluids (pre-warmed fluids at 37–42°C) compared to the control group.
    • Low quality evidence from 1 RCT (n=44) shows a clinically important difference in the incidence of shivering between the groups, with a lower incidence of shivering in the group who received warmed IV fluids (pre-warmed fluids at 30–34°C) compared to the control group.
    • Very low quality evidence from 1 RCT (n=40) shows no clinically important difference in the incidence of shivering between groups who received warmed IV fluids (maintained fluid warming at 36.5°C) compared to control group.
Estimated blood loss
  • Low quality evidence from 4 RCTs (n=249) shows no clinically important difference in the volume of blood loss between the group who received warmed IV fluids compared to the control group.
    Subgroup analysis:
    • Low quality evidence from 1 RCT (n=149) shows no clinically important difference in estimated blood loss between the group who received warmed IV fluids (maintained fluid warming 37–42°C) compared to the control group.
    • Moderate quality evidence from 1 RCT (n=60) shows no clinically important difference in estimated blood loss between the group who received warmed IV fluids (pre-warmed fluids at 37–42°C) compared to the control group
    • Very low quality evidence from 1 RCT (n=40) shows no clinically important difference in estimated blood loss between the group who received warmed IV fluids (maintained fluid warming at 36.5°C) compared to control group
  • Very low quality evidence from 1 RCT (n=67) shows no clinically important difference in the need for blood products between the group who received warmed IV fluids compared to the control group.
Important outcomes
Maternal (core) temperature change
  • Low quality evidence from 2 RCTs (n=70) shows a clinically important difference in maternal temperature with less of a fall (change) in core temperature in the group who received warmed IV fluids compared to the control group.
Maternal temperature at different time points
  • Intra-operative: Very low quality evidence from 3 RCTs (n=246) shows a clinically important difference in intra-operative maternal temperature between groups, with a higher core temperature in the group who received warmed IV fluids compared to the control group.
  • Post-op, baseline, and 30 minutes later: Very low and low quality evidence from 2 RCTs (n=97) shows a clinically important difference in maternal temperature at these time points with a higher core temperature in the group who received warmed IV fluids compared to the control group.
  • Post-op, 45 minutes or later: Very low quality evidence from 3 RCTs (n=246) shows a clinically important difference in maternal temperature at these time points with a higher core temperature in the group who received warmed IV fluids compared to the control group.
  • Post-op, discharge/postpartum: Very low quality evidence from 2 RCTs (n=216) shows a clinically important difference in maternal temperature at these time points with a higher core temperature in the group who received warmed IV fluids compared to the control group.
Thermal comfort
  • Very low quality evidence from 1 RCT (n=30) shows no clinically important difference in thermal comfort between the group who received warmed IV fluids compared to the control group.
  • High quality evidence from 1 RCT (n=75) shows a clinically important difference in thermal comfort with a lower incidence of scoring low (<4) on thermal comfort in the group who received warmed IV fluids compared to the control group.
  • Low quality evidence from 1 RCT (n=75) shows no clinically important difference in thermal comfort (incidence of scoring high (>6) on thermal comfort) between the group who received warmed IV fluids compared to the control group.
Wound infection
  • No evidence was available for this outcome.
Comparison 2. Forced air warming versus control
Critical outcomes
Incidence of hypothermia
  • Very low quality evidence from 3 RCTs (n=157) shows no clinically important difference in the incidence of hypothermia between the group who received forced air warming compared to the control group, overall or for either subgroup (background of no additional warming or background of maintained warmed IV fluids).
Incidence of shivering
  • Low quality evidence from 6 RCTs (n=242) shows a clinically important difference in the incidence of shivering, with a lower incidence in the forced air warming group compared to the control group.
Estimated blood loss
  • Low quality evidence from 3 RCTs (N=147) shows no clinically important difference in estimated blood loss between the group who received forced air warming compared to the control group, overall or for either subgroup (background of no additional warming or background of maintained warmed IV fluids).
Important outcomes
Maternal temperature change
  • Peri-operative change: Very low quality evidence from 1 RCT (n=30) shows no clinically important difference in rate of change of temperature between the group who received forced air warming compared to the control group.
  • Intra-operative change: Very low quality evidence from 3 RCTs (n=142) shows no clinically important difference in rate of change of temperature between the group who received forced air warming compared to the control group.
Maternal temperature at different time points
  • Intra-operative, within 30 minutes: Very low quality evidence from 2 RCTs (n=127) shows no clinically important difference in maternal temperature at this time point between the group who received forced air warming compared to the control group.
  • Intra-operative, immediately post-delivery: Very low quality evidence from 1 RCT (n=40) shows no clinically important difference in maternal temperature at this time point between the group who received forced air warming compared to the control group.
  • Intra-operative, end of surgery: Very low quality evidence from 4 RCTs (n=219) shows a clinically important difference in maternal temperature at this time point between the groups, with a higher core temperature in the group who received forced air warming group compared to the control group.
  • Post-op, recovery room, within 15 minutes: Very low quality evidence from 1 RCT (n=87) shows a clinically important difference in maternal temperature at this time point between the groups, with a higher core temperature in the group who received forced air warming group compared to the control group.
Thermal comfort
  • Pre-operative: Very low quality evidence from 2 RCTs (n=70) shows a clinically important difference in thermal comfort between groups, with a higher level of thermal comfort in the group who received forced air warming compared to the control group.
  • Intra-operative, immediately post-delivery: Very low quality evidence from 1 RCT (n=40) shows a clinically important difference in thermal comfort between groups, with a higher level of thermal comfort in the group who received forced air warming compared to the control group.
  • Intra-operative, end of surgery: Low quality evidence from 1 RCT (n=40) shows a clinically important difference in thermal comfort between groups, with a higher level of thermal comfort in the group who received forced air warming compared to the control group.
  • Post-operative: Low quality evidence from 3 RCTs (N=110) shows no clinically important difference in thermal comfort between the group who received forced air warming compared to the control group, overall or for either subgroup (post-op discharge or peri-operative)
Wound infection
  • Very low quality evidence from 1 RCT (n=87) shows no clinically important difference in wound infection between the group who received forced air warming compared to the control group.
Comparison 3. Forced air warming + warmed IV fluid versus control
Critical outcomes
Incidence of hypothermia
  • Moderate quality evidence from 1 RCT (n=44) shows a clinically important difference in incidence of hypothermia between the groups, with a lower incidence of hypothermia in the in the group who received forced air warming and warmed IV fluid compared to the control group.
Incidence of shivering
  • Intra-operative: Moderate quality evidence from 1 RCT (n=44) shows no clinically important difference in shivering between group who received forced air warming and warmed IV fluid compared to the control group.
  • Post-operative: Low quality evidence from 1 RCT (n=44) shows no clinically important difference in shivering between group who received forced air warming and warmed IV fluid compared to the control group.
Estimated blood loss
  • Low quality evidence from 1 RCT (n=44) shows no clinically important difference in estimated blood loss between group who received forced air warming and warmed IV fluid compared to the control group, based on the wide inter-quartile range (IQR) in both groups.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • Intra-operative/recovery room, baseline: Moderate quality evidence from 1 RCT (n=44) shows a clinically important difference in maternal temperature at these time points between groups, with a higher core temperature in the group who received forced air warming and warmed IV fluid compared to the control group.
Thermal comfort
  • Post-op/recovery room, discharge: Low quality evidence from 1 RCT (n=44) shows no clinically important difference in thermal comfort between group who received forced air warming and warmed IV fluid compared to the control group, based on the wide IQR in both groups
Wound infection
  • No evidence was available for this outcome.
Comparison 4. Warmed mattress/under-body pad versus control
Critical outcomes
Incidence of hypothermia
  • Very low quality evidence from 3 RCTs (n=357) shows no clinically important difference in the incidence of hypothermia between the group who received a warmed mattress/under-body pad compared to the control group.
    Subgroup analysis:
    • Undefined time point: Low quality evidence from 2 RCTs (n=204) shows a clinically important difference in the incidence of hypothermia between groups, with a lower incidence of hypothermia in the group who received a warmed mattress/under-body pad compared to the control group.
    • Postpartum: Very low quality evidence from 1 RCT (n=153) shows no clinically important difference in the incidence of hypothermia between the group who received a warmed mattress/under-body pad compared to the control group.
Incidence of shivering
  • Very low quality evidence from 1 RCT (n=116) shows no clinically important difference in the incidence of shivering between the group who received a warmed mattress/under-body pad compared to the control group.
Estimated blood loss
  • Low quality evidence from 1 RCT (n=241) shows no clinically important difference in estimated blood loss between the group who received a warmed mattress/under-body pad compared to the control group.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome
Maternal temperature at different time points
  • Intra-operative: Very low quality evidence from 3 RCTs (n=357) shows a clinically important difference in maternal temperature between groups, with a higher core temperature in the group who received a warmed mattress/under-body pad compared to the control group.
    Subgroup analysis:
    • First 30 minutes: Moderate quality evidence from 2 RCTs (n=204) shows no clinically important difference in maternal temperature between the group who received a warmed mattress/under-body pad compared to the control group.
    • Anytime in operating room: Very low quality evidence from 1 RCT (n=153) shows a clinically important difference in maternal temperature between the groups, with a higher core temperature in the group who received a warmed mattress/under-body pad compared to the control group.
  • Intra-op, recovery room, baseline: very low quality evidence from 2 RCTs (n=204) shows no clinically important difference in maternal temperature between the group who received a warmed mattress/under-body pad compared to the control group.
  • Post-op, recovery room: Very low quality evidence from 2 RCTs (n=241) shows no clinically important difference in maternal temperature between the group who received a warmed mattress/under-body pad compared to the control group.
  • Post-op, postpartum: Low quality evidence from 1 RCT (n=153) shows a clinically important difference in maternal temperature between the groups, with a higher core temperature in the group who received a warmed mattress/under-body pad compared to the control group.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • Very low quality evidence from 1 RCT (n=88) shows no clinically important difference in wound infections between the group who received a warmed mattress/under-body pad compared to the control group.
Active warming measures versus other active warming
Comparison 5. Forced air warming versus warmed IV fluids
Critical outcomes
Incidence of hypothermia
  • No evidence was available for this outcome.
Incidence of shivering
  • Very low quality evidence from 1 RCT (n=30) shows no clinically important difference in the incidence of shivering between the group who received forced air warming compared to the group who received warmed IV fluids.
Estimated blood loss
  • Very low quality evidence from 1 RCT (n=30) shows no clinically important difference in estimated blood loss between the group who received forced air warming compared to the group who received warmed IV fluids.
Important outcomes
Maternal temperature change
  • Intra-operative, 45 minutes post-intervention: Very low quality evidence from 1 RCT (n=30) shows no clinically important difference in rate of change of temperature between the group who received forced air warming compared to the group who received warmed IV fluids.
Maternal temperature at different time points
  • No evidence was available for this outcome.
Thermal comfort
  • Very low quality evidence from 1 RCT (n=30) shows no clinically important difference in thermal comfort between the group who received forced air warming compared to the group who received warmed IV fluids.
Wound infection
  • No evidence was available for this outcome.
Comparison 6. Forced air warming versus mattress warming
Critical outcomes
Incidence of hypothermia
  • Very low quality evidence from 1 RCT (n=87) shows no clinically important difference in the incidence of hypothermia between the group who received forced air warming compared to the group who received mattress warming.
Incidence of shivering
  • No evidence was available for this outcome.
Estimated blood loss
  • Low quality evidence from 1 RCT (n=87) shows no clinically important difference in estimated blood loss between the group who received forced air warming compared to the group who received mattress warming.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • Pre-operative, 15 minutes post-anaesthetic: Low quality evidence from 1 RCT (n=87) shows no clinically important difference in maternal temperature between the group who received forced air warming compared to the group who received mattress warming.
  • Intra-operative, recovery room, baseline: Low quality evidence from 1 RCT (n=87) shows no clinically important difference in maternal temperature between the group who received forced air warming compared to the group who received mattress warming.
  • Post-operative, recovery room, after 15 minutes: Very low quality evidence from 1 RCT (n=87) shows a clinically important difference in maternal temperature between groups, with a higher core temperature in the group who received forced air warming compared to the group who received mattress warming.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • Very low quality evidence from 1 RCT (n=87) shows no clinically important difference in wound infections between the group who received forced air warming compared to the group who received mattress warming.
Comparison 7. Warmed mattress/under body pad versus other warming (not control/ usual care)
Critical outcomes
Incidence of hypothermia
  • Very low quality evidence from 1 RCT and 1 cluster RCT (n=412) shows a clinically important difference in incidence of hypothermia between groups, with a lower incidence of hypothermia in the warmed mattress group compared to other warming group.
    Subgroup analysis:
    • Very low quality evidence from 1 cluster RCT (n=262) shows a clinically important difference in the incidence of hypothermia between the groups, with a lower incidence of hypothermia in the warmed mattress group compared to other warming group, for the subgroup where the other warming group used warmed IV fluids, tinfoil hats, and warmed blankets.
    • Very low quality evidence from 1 RCT (n=150) shows no clinically important difference in the incidence of hypothermia between the groups, for the subgroup where the other warming group used warmed IV fluids only.
Incidence of shivering
  • No evidence was available for this outcome.
Estimated blood loss
  • Very low quality evidence from 1 RCT (n=150) shows no clinically important difference in estimated blood loss between the warmed mattress group compared to other warming group.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • Intra-operative: Very low quality evidence from 1 RCT and 1 cluster RCT (n=412) shows no clinically important difference in maternal temperature between the warmed mattress group compared to other warming group.
    Subgroup analysis:
    • Very low quality evidence from 1 cluster RCT (n=262) shows a clinically important difference in maternal temperature between the groups, with a higher core temperature in the warmed mattress group compared to other warming, for the subgroup where the other warming group used warmed IV fluids, tinfoil hats, and warmed blankets.
    • Low quality evidence from 1 RCT (n=150) shows no clinically important difference in maternal temperature between the warmed mattress group compared to other warming group, for the subgroup where the other warming group used warmed IV fluids only.
  • Post-operative, recovery room: very low quality evidence from 1 RCT and 1 cluster RCT (n=634) shows no clinically important difference in maternal temperature between the warmed mattress group compared to other warming group, overall or in either subgroup.
  • Post-operative, postpartum: Low quality evidence from 1 RCT (n=150) shows no clinically important difference in maternal temperature between the warmed mattress group compared to other warming group.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • Very low quality evidence from 1 cluster RCT (n=484) shows no clinically important difference in wound infection between the warmed mattress group compared to other warming group.
Thermal insulation measures
Comparison 8. Higher versus lower ambient temperature
Critical outcomes
Incidence of hypothermia
  • Very low quality evidence from 1 cluster RCT (n=791) shows no clinically important difference in the incidence of hypothermia between the higher ambient temperature group compared to the lower ambient temperature group.
Incidence of shivering
  • No evidence was available for this outcome.
Estimated blood loss
  • No evidence was available for this outcome.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • No evidence was available for this outcome.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • Very low quality evidence from 1 cluster RCT (n=791) shows no clinically important difference in wound infection between the higher ambient temperature group compared to the lower ambient temperature group.
Pharmacological therapy
Comparison 9. 5-HT3 antagonist versus control
Critical outcomes
Incidence of hypothermia
  • No evidence was available for this outcome.
Incidence of shivering
  • Very low quality evidence from 1 RCT (n=116) shows no clinically important difference in the incidence of shivering between the group receiving a 5-HT3 antagonist and the control group.
  • Very low quality evidence from 1 RCT (n=116) shows no clinically important difference in the incidence of shivering reaching a maximum value of 2–4 between the group receiving a 5-HT3 antagonist and the control group.
Estimated blood loss
  • No evidence was available for this outcome.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • No evidence was available for this outcome.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • No evidence was available for this outcome.
Comparison 10. Opioid-like analgesic (pethidine) versus other opioid (morphine)
Critical outcomes
Incidence of hypothermia
  • No evidence was available for this outcome.
Incidence of shivering
  • Very low quality evidence from 1 RCT (n=119) shows a clinically important difference in the incidence of shivering between the groups, with a lower incidence of shivering in the pethidine group compared to the morphine group.
    Subgroup analysis:
    • Very low quality evidence from 1 RCT (n=59) shows no clinically important difference in the incidence of shivering between pethidine group compared to the morphine group, for the subgroup who received 10mg pethidine compared to 0.1mg morphine
    • Very low quality evidence from 1 RCT (n=60) shows no clinically important in the incidence of shivering between pethidine group compared to the morphine group, for the subgroup who received 10mg pethidine compared to 0.2mg morphine
Estimated blood loss
  • No evidence was available for this outcome.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • No evidence was available for this outcome.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • No evidence was available for this outcome.
Comparison 11a. Opioid-like analgesic versus control for prevention
Critical outcomes
Incidence of hypothermia
  • No evidence was available for this outcome.
Incidence of shivering
  • Low quality evidence from 3 RCTs (n=313) shows a clinically important difference in the incidence of shivering between groups, with a lower incidence of shivering in the opioid-like analgesic group compared to the control group.
    Subgroup analysis:
    • Low quality evidence from 1 RCT (n=94) shows a clinically important difference in the incidence of shivering between groups, with a lower incidence of shivering in the opioid-like analgesic group compared to the control group, for the sub-group receiving 25mg pethidine.
    • Very low quality evidence from 1 RCT (n=60) shows no clinically important difference in the incidence of shivering in the opioid-like analgesic group compared to the control group, for the sub-group receiving 10mg pethidine.
    • Low quality evidence from 1 RCT (n=40) shows a clinically important difference in the incidence of shivering between groups, with a lower incidence of shivering in the opioid-like analgesic group compared to the control group, for the sub-group receiving 0.2mg/kg meperidine.
    • Very low quality evidence from 1 RCT (n=59) shows no clinically important difference in the incidence of shivering in the opioid-like analgesic group compared to the control group, for the sub-group receiving 0.1mg morphine.
    • Very low quality evidence from 1 RCT (N=60 shows no clinically important difference in the incidence of shivering in the opioid-like analgesic group compared to the control group, for the sub-group receiving 0.2mg morphine.
Estimated blood loss
  • No evidence was available for this outcome.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • No evidence was available for this outcome.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • No evidence was available for this outcome.
Comparison 11b. Opioid-like analgesic (meperidine) versus control for management
Critical outcomes
Incidence of hypothermia
  • No evidence was available for this outcome.
Incidence of shivering
  • At 2, 5, 15, 30, and 60 minutes post infusion: Low quality evidence from 1 RCT (n=40) shows a clinically important difference in the incidence of shivering at these time points between groups, with a lower incidence of shivering in the meperidine group compared to the control group.
Estimated blood loss
  • No evidence was available for this outcome.
Important outcomes
Rate of change of temperature (maternal temperature change)
  • No evidence was available for this outcome.
Maternal temperature at different time points
  • At 2 and 5 minutes post infusion: Very low quality evidence from 1 RCT (n=40) shows no clinically important difference in maternal temperature at these time points between the meperidine group and the control group.
  • At 15, 30, and 60 minutes post infusion: Low quality evidence from 1 RCT (n=40) shows a clinically important difference in maternal temperature at these time points between groups, with a higher core temperature in the control group compared to meperidine group.
Thermal comfort
  • No evidence was available for this outcome.
Wound infection
  • No evidence was available for this outcome.
Economic evidence statements

No economic evidence was identified which was applicable to this review question.

The committee’s discussion of the evidence
Interpreting the evidence
The outcomes that matter most

The incidence of hypothermia and shivering were considered to be the critical outcomes for this review as these were the symptoms of interest. Hypothermia may adversely affect clotting and so estimated blood loss was also considered to be critical outcome.

Hypothermia may also impair wound healing and so wound infection was an important outcome. Maternal temperature and rate of change of temperature were considered important as they would indicate if the prevention or management of hypothermia had been successful. Finally, as hypothermia and shivering are reported by women as impairing their experience of childbirth, thermal comfort was selected as an important outcome.

The quality of the evidence

The quality of evidence for this review was assessed using GRADE.

For active warming measures, the evidence was very low to moderate quality with only one outcome (from a small single study) in one comparison deemed high quality (thermal comfort score<4, n=75, comparison 1). The evidence for thermal insulation measures and pharmacological therapy was assessed as very low to low quality for all outcomes of interest.

Quality was largely downgraded for imprecision (wide confidence intervals), and unclear or high risk of bias across multiple domains (blinding of participants/personnel, and outcomes).

Benefits and harms

The committee discussed the potential causes of shivering and hypothermia during a caesarean birth, which may in part be due to the effects of the epidural or spinal anaesthesia. As the majority (up to 99% of elective and 97% of emergency caesarean births) are performed under regional anaesthesia, some complications such as shivering and thermal discomfort are evident in both the intra-operative and post-operative period. The committee noted that the incidence of hypothermia and shivering had decreased since the introduction of drapes which collected the amniotic fluid and so reduced the quantity of wet drapes that were in contact with the woman’s skin.

The committee noted that there were already existing NICE guidelines on Hypothermia: prevention and management in adults having surgery (NICE CG65, 2008), and that this guideline provides guidance on the importance of avoiding peri-operative hypothermia to reduce the risk of postoperative complications, such as increased perioperative blood loss, longer post-anaesthetic recovery, postoperative shivering, thermal discomfort, morbid cardiac events including arrhythmia, altered drug metabolism, increased risk of wound infection, reduced patient satisfaction with the surgical experience, and longer stay in hospital. The committee discussed the differences between caesarean birth and general surgery populations, and noted that the risk of some of these adverse effects was reduced in women undergoing caesarean birth as they were usually younger, fitter and healthier than the general surgical population. In particular, the committee noted that the incidence of wound infection was low after caesarean birth, and so it may be difficult to see a difference in wound infection rates due to interventions for shivering and hypothermia.

The committee then discussed the evidence regarding the efficacy of different approaches to prevent hypothermia and reduce the risk of complications in women having a caesarean birth.

The evidence showed that none of the interventions reduced estimated blood loss. However, the committee agreed that if major obstetric haemorrhage occurs, maternal hypothermia can be a factor in impairing the function of coagulation proteins. It is therefore useful to maintain core temperature in women undergoing caesarean birth (particularly those at increased risk of post-partum haemorrhage) to minimise the risk of coagulopathy.

Similarly, none of the warming methods reduced the incidence of wound infection. However, the committee noted that the incidence of wound infection in the studies was very low (1/791 in Duryea 2016 and 5/484 in Grant 2015) so the trials were unlikely to have been powered to detect a difference.

The committee noted that each method of active warming showed benefit compared to usual care (control) in the incidence of shivering and hypothermia, or in maternal temperature or thermal comfort. The comparisons of different active warming measures with each other showed that there were few significant differences between groups. Active warming measures showed benefit with regards to thermal comfort when they were applied intra-operatively, with fewer differences postoperatively when the active warming had been removed.

The committee noted that current NICE guideline for general surgical procedures recommend forced air warming measures when the procedure is longer than 30 minutes. The committee agreed that all caesarean births fulfil this criterion, and discussed that if they made recommendations consistent with general surgical guidelines, this would mean that all women undergoing caesarean birth would receive forced air warming. However, the committee again noted the physiological differences between women having a caesarean birth and the general surgical population – pregnant women retain heat more effectively, likely due to their comparatively young age and better health (for example, fewer comorbidities). Thus using additional warming before the woman experiences a drop in core temperature or initiation of shivering may not be necessary, and even though the majority of the evidence was for the prevention of hypothermia and shivering, not for management, the committee agreed that they would expect forced air warming methods to work well for management and so recommended its use for women who develop shivering or hypothermia. The committee agreed that a temperature of less than 36°C was an appropriate threshold used to define a patient who was hypothermic and at which there was an increased risk of adverse effects due to a reduced body temperature. This was also the threshold used in the NICE guideline for general surgical procedures and so the committee set this as the temperature threshold at which forced air warming should be commenced.

The use of warmed IV fluids alone or when in combination with another active warming measure (for example, forced air warming), was beneficial when compared to standard care/unwarmed fluids. Again, the committee noted that the current NICE guideline for general surgical procedures recommends warmed intravenous fluids and blood products if the volume is greater than 500 ml. The committee discussed the fact that women may receive small volume infusions (for example, antibiotics or analgesics) and these would not need warming, but agreed that all larger volumes could have a cooling effect if administered unwarmed. The committee noted that the studies included in the review used a variety of different methods to warm IV fluids – some used a warming cabinet, some used an in-line warmer, and 1 study used a combination of both. The committee therefore chose to not specify exactly which method should be used to warm IV fluids, and noted that this was the same as the recommendation in the NICE guideline for general surgical procedures which does not state the method to be used. The committee also noted that the studies warmed fluids to a variety of temperatures, but agreed that fluids should normally be warmed and administered at body temperature of 37°C. The committee discussed that there was no evidence from this review for the warming of irrigation fluids where used, but that this is considered best practice in all surgery, and is recommended in the NICE guideline for general surgical procedures. The committee therefore agreed to adopt the recommendation from this guideline for the prevention of shivering and hypothermia in women having a caesarean birth. The temperature range of 38°C to 40°C was also adopted from this guideline and the committee agreed that this was in accordance with their clinical experience, as irrigation fluids were warmed in a cabinet, and then removed for administration, so would cool down to 37°C by the time they were administered.

The committee discussed the availability of the various active warming measures assessed in the review and agreed that mattress warming/under-body pads were not widely used or available, would have to remain in the surgical suite, and had issues around cleaning and reusability. Forced air warming used disposable ‘blankets’ into which hot air could be blown, and could be utilised at multiple stages of the procedure, travelling with the woman into recovery and onto the ward if appropriate. The committee therefore recommended forced air warming and noted that this was in line with the recommendations in the current NICE guideline for general surgical procedures.

The evidence showed there was no benefit from the higher ambient temperature compared to the lower ambient temperature (thermal insulation) in the prevention of shivering and hypothermia, However, the committee agreed that the small (3°C) difference between 20°C and 23°C room temperature in the study was insufficient to make a difference to outcomes, and they routinely maintain temperatures above this during most surgical procedures already, and so did not make a recommendation.

The evidence for pharmacological interventions showed a benefit of opioids (pethidine/meperidine) to prevent and manage shivering, and this was the only comparison that looked specifically at the management of hypothermia and shivering as opposed to primary prevention. Intravenous pethidine (50 mg, immediately post-delivery) was used in women having a caesarean birth under epidural anaesthesia with lidocaine and adrenaline. This significantly reduced the incidence and severity of shivering without increasing the incidence of nausea or need for anti-emetics. The incidence of shivering in the control group was high (87%), which was attributed to the cold operating theatre and rapid infusion of cold solutions. The committee noted that there was a higher incidence of shivering but a lower incidence of hypothermia in the control group of women who were already shivering, but discussed that this may be due to the fact that the act of shivering raises core temperature, and so administering of the opioid reduced shivering but then led to a lower body temperature compared to the control group.

The committee considered the use of opioids as a second line treatment (following the implementation of active warming measures if this was ineffective). However, after further discussion they agreed that despite the evidence for opioids (pethidine) in both prevention and management of shivering and hypothermia, its use during a caesarean birth would negatively impact the woman’s ability to breastfeed in the hours after birth, and consequently they did not make a recommendation to use opioids. The committee also noted that although pethidine was the only intervention assessed for use in management once hypothermia and shivering occurs, this evidence was from one small study conducted in the 1980s.

The evidence for the 5-HT3 antagonist (ondansetron) showed no benefit in preventing shivering and the committee considered whether to make a recommendation highlighting the fact it should not be used for this purpose. However, the committee decided not to make a ‘do not use’ recommendation as ondansetron is used to prevent and treat nausea and vomiting, so having a recommendation that it should not be used could be confusing for healthcare professionals.

The committee agreed that one of the main benefits of measures to prevent and manage hypothermia and shivering, such as use of forced air warming, was that it made the woman more comfortable and improved their birth experience, and that this was important to take into account.

Cost effectiveness and resource use

The committee discussed the cost implications of hypothermia and shivering, and noted that current practice is to retain the woman in the recovery ward if she is still shivering or has a core temperature below 36°C (hypothermia), so effective prevention and management of hypothermia and shivering may allow women to return to the postnatal ward earlier which would reduce resource use.

The committee noted that the cost-benefit analysis in the NICE guideline for the general surgical population had found that the expenditure on devices that were proven to prevent hypothermia was cost effective due to the reduction in wound infections. However, as noted above the rate of wound infection after caesarean birth is low, and no reduction in wound infection had been seen in this population.

The committee discussed the cost of the forced air warming blankets which were approximately £15 to £25 each, and recognised that even if the blankets were only used in women who were shivering or hypothermic, and not as prevention, there may be some cost implications to the NHS, depending on local current practice. However, they also noted that the number of women who would require warming would be a relatively low proportion of those having a caesarean birth as the room temperature is kept warm and warmed IV and irrigations fluids are used.

The committee agreed that warming of IV fluids and blood during infusion and warming irrigation fluids in a warming cabinet prior to administration is already standard practice.

References
  • Browning 2013

    Browning, R. M., Fellingham, W. H., O’Loughlin, E. J., Brown, N. A., Paech, M. J., Prophylactic ondansetron does not prevent shivering or decrease shivering severity during cesarean delivery under combined spinal epidural anesthesia: a randomized trial, Regional Anesthesia & Pain Medicine, 38, 39–43, 2013 [PubMed: 23104146]
  • Butwick 2007

    Butwick, A. J., Lipman, S. S., Carvalho, B., Intraoperative forced air-warming during cesarean delivery under spinal anesthesia does not prevent maternal hypothermia, Anesthesia & Analgesia, 105, 1413–9, table of contents, 2007 [PubMed: 17959975]
  • Casey 1988

    Casey, W. F., Smith, C. E., Katz, J. M., O’Loughlin, K., Weeks, S. K., Intravenous meperidine for control of shivering during caesarean section under epidural anaesthesia, Canadian Journal of Anaesthesia, 35, 128–33, 1988 [PubMed: 3356050]
  • Chakladar 2014

    Chakladar, A., Dixon, M. J., Crook, D., Harper, C. M., The effects of a resistive warming mattress during caesarean section: a randomised, controlled trial, International Journal of Obstetric Anesthesia, 23, 309–16, 2014 [PubMed: 25266313]
  • Chan 1989

    Chan, V. W., Morley-Forster, P. K., Vosu, H. A., Temperature changes and shivering after epidural anesthesia for cesarean section, Regional Anesthesia, 14, 48–52, 1989 [PubMed: 2486587]
  • Chebbout 2017

    Chebbout, R., Newton, R. S., Walters, M., Wrench, I. J., Woolnough, M., Does the addition of active body warming to in-line intravenous fluid warming prevent maternal hypothermia during elective caesarean section? A randomised controlled trial, International Journal of Obstetric Anesthesia, 27, 27, 2017 [PubMed: 28576354]
  • Chung 2012

    Chung, S. H., Lee, B. S., Yang, H. J., Kweon, K. S., Kim, H. H., Song, J., Shin, D. W., Effect of preoperative warming during cesarean section under spinal anesthesia, Korean Journal of Anesthesiology, 62, 454–60, 2012 [PMC free article: PMC3366313] [PubMed: 22679543]
  • Cobb 2016

    Cobb, B., Cho, Y., Hilton, G., Ting, V., Carvalho, B., Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial, Anesthesia & Analgesia, 122, 1490–7, 2016 [PubMed: 26895002]
  • Duryea 2016

    Duryea, E. L., Nelson, D. B., Wyckoff, M. H., Grant, E. N., Tao, W., Sadana, N., Chalak, L. F., McIntire, D. D., Leveno, K. J., The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial, American Journal of Obstetrics & Gynecology, 214, 505.e1–7, 2016 [PubMed: 26874298]
  • Fallis 2006

    Fallis, W. M., Hamelin, K., Symonds, J., Wang, X., Maternal and newborn outcomes related to maternal warming during cesarean delivery, JOGNN - Journal of Obstetric, Gynecologic, & Neonatal Nursing, 35, 324–31, 2006 [PubMed: 16700681]
  • Grant 2015

    Grant, E. N., Craig, M. G., Tao, W., McIntire, D. D., Leveno, K. J., Active Warming during Cesarean Delivery: Should We SCIP It?, American Journal of Perinatology, 32, 933–8, 2015 [PubMed: 25738786]
  • Hong 2005

    Hong, J. Y., Lee, I. H., Comparison of the effects of intrathecal morphine and pethidine on shivering after Caesarean delivery under combined-spinal epidural anaesthesia, Anaesthesia, 60, 1168–72, 2005 [PubMed: 16288613]
  • Horn 2002

    Horn, E. P., Schroeder, F., Gottschalk, A., Sessler, D. I., Hiltmeyer, N., Standl, T., Schulte am Esch, J., Active warming during cesarean delivery, Anesthesia & Analgesia, 94, 409–14, table of contents, 2002 [PubMed: 11812709]
  • Horn 2014

    Horn, E. P., Bein, B., Steinfath, M., Ramaker, K., Buchloh, B., Hocker, J., The incidence and prevention of hypothermia in newborn bonding after cesarean delivery: a randomized controlled trial, Anesthesia & Analgesia, 118, 997–1002, 2014 [PubMed: 24681658]
  • Jorgensen 2000

    Jorgensen, H. S., Bach, L. F., Helbo-Hansen, H. S., Nielsen, P. Aa, Warm or cold saline for volume preload before spinal anaesthesia for caesarean section?, International Journal of Obstetric Anesthesia, 9, 20–25, 2000 [PubMed: 15321106]
  • Munday 2018

    Munday, J., Osborne, S., Yates, P., Sturgess, D., Jones, L., Gosden, E., Preoperative Warming Versus no Preoperative Warming for Maintenance of Normothermia in Women Receiving Intrathecal Morphine for Cesarean Delivery: A Single-Blinded, Randomized Controlled Trial, Anesthesia and Analgesia, 126, 183–189, 2018 [PubMed: 28514320]
  • NICE 2008

    NICE. Hypothermia: prevention and management in adults having surgery. Clinical guideline 65. 23 April 2008.
  • Paris 2014

    Paris, L. G., Seitz, M., McElroy, K. G., Regan, M., A randomized controlled trial to improve outcomes utilizing various warming techniques during cesarean birth, JOGNN - Journal of Obstetric, Gynecologic, & Neonatal Nursing, 43, 719–28, 2014 [PubMed: 25316112]
  • Roy 2004

    Roy, J. D., Girard, M., Drolet, P., Intrathecal meperidine decreases shivering during cesarean delivery under spinal anesthesia, Anesthesia & Analgesia, 98, 230–4, table of contents, 2004 [PubMed: 14693625]
  • Smith 2000

    Smith, Charles E, Fisgus, John R, Kan, Margaret, Lengen, Sarah K, Myles, Clifford, Jacobs, Dennis, Choi, Emil, Bolden, Norman, Pinchak, Alfred C, Hagen, Joan F, Original Studies-Efficacy of IV Fluid Warming in Patients Undergoing Cesarean Section With Regional Anesthesia-Does warming IV fluids result in higher core temperatures and less intraoperative, American Journal of Anesthesiology, 27, 84–88, 2000
  • Sutherland 1991

    Sutherland, J., Seaton, H., Lowry, C., The influence of epidural pethidine on shivering during lower segment caesarean section under epidural anaesthesia, Anaesthesia & Intensive Care, 19, 228–32, 1991 [PubMed: 2069245]
  • Woolnough 2009

    Woolnough,M., Allam,J., Hemingway,C., Cox,M., Yentis,S.M., Intra-operative fluid warming in elective caesarean section: a blinded randomised controlled trial, International Journal of Obstetric Anesthesia, 18, 346–351, 2009 [PubMed: 19665366]
  • Workhoven 1986

    Workhoven, M. N., Intravenous fluid temperature, shivering, and the parturient, Anesthesia & Analgesia, 65, 496–8, 1986 [PubMed: 3963436]
  • Yokoyama 2009

    Yokoyama,K., Suzuki,M., Shimada,Y., Matsushima,T., Bito,H., Sakamoto,A., Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery, Journal of Clinical Anesthesia, 21, 242–248, 2009 [PubMed: 19502035]

Appendices

Appendix A. Review protocols

Review protocol for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

Table 3Review protocol for hypothermia and shivering

Field (based on PRISMA-P)Content
Actual review questionWhat are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?
Type of review questionIntervention
Objective of the review

To identify the most effective methods to prevent hypothermia or shivering from occurring, and the most effective methods to manage hypothermia and shivering in women having a caesarean birth. Interventions will be considered for the pre-operative, intra-operative and post-operative periods. The focus of this review is on maternal outcomes, rather than neonatal outcomes.

Background: Shivering increases oxygen consumption dramatically, therefore patients are put at risk of cardiac complications. However, this is more of a problem for the elderly, and people with pre-existing cardiac disease (not common in the obstetric population). Shivering also has practical consequences, as it makes it difficult to monitor blood pressure using non-invasive methods (e.g. oscillometric blood pressure monitors). Hypothermia is a concern as it affects blood clotting and wound healing. In the non-obstetric population, the majority of surgical procedures are carried out under general anaesthesia, which prevents intra-operative shivering and allows the patient to be fully covered to prevent heat loss. The opposite is true for women having caesarean birth where almost all procedures are performed using a regional anaesthetic.

Eligibility criteria – population/disease/condition/issue/domain

For prevention of hypothermia/shivering:

All women undergoing caesarean birth

  • include any of the different modes of anaesthesia (general anaesthesia/epidural anaesthesia/spinal anaesthesia)
  • include any type of caesarean birth (emergency or planned)
For management of hypothermia/shivering

Women undergoing caesarean birth who are identified as having hypothermia and/or shivering

  • include any of the different modes of anaesthesia (general anaesthesia/epidural anaesthesia/spinal anaesthesia)
  • include any type of caesarean birth (emergency or planned)

Eligibility criteria – intervention(s)/exposure(s)/prognostic factor(s)
  • Active warming measures (a process that transfers heat to the patient)
    • forced air warming
    • electric blanket
    • radiant heater
    • warmed cotton blankets
    • fluid warming including
      -

      (IV) fluid warmers (including blood/blood products)

      -

      other methods of fluid warming

    • heating pad
  • Thermal insulation measures (for example,
    • leg wrapping
    • compression boots
    • room temperature
    • reflective (“space”) blankets
  • Pharmacological therapy
    • used to reduce heat redistribution (e.g. vasoconstrictors, such as phenylephrine, metaraminol, noradrenaline/norepinephrine)
    • Other post-delivery drugs
      -

      Pethidine

Eligibility criteria – comparator(s)/control or reference (gold) standard
  • Each of the interventions outlined above
  • Placebo
  • No treatment/usual care
    • consider other interventions such as cotton sheets, cotton blankets or wool blankets as “usual care”
Outcomes and prioritisation Critical outcomes:
  • Incidence of hypothermia
  • Shivering
  • Estimated blood loss
Important outcomes
  • Rate of change of temperature/ Maternal temperature change (increase or decrease)
  • Maternal temperature at different time points
  • Thermal comfort
  • Wound infection
As noted, this question covers three distinct time periods – pre-, peri- and post-operative. There are also three relevant time periods for reporting of outcomes
  • during the pre-operative period (the hour before the start of surgery)
    • includes outcomes reported at induction of anaesthesia (relevant for pre-warming interventions)
  • intra-operative period
    • e.g. 30 minutes into surgery, 60 minutes into surgery
    • includes outcomes reported at end of surgery/transfer to recovery room
  • post-operative period
    • includes up to 24 hours post-surgery
    • first 2 hours post-surgery are the most relevant
      • If studies report outcomes at multiple time points, only those up to 2 hours post-op will be reported.
      • If a study reports post-op outcomes at a time after 2 hours, but within the first 24 hours, then the nearest time point to 2 hours will be reported.
Eligibility criteria – study designOnly published full text papers
  • Systematic reviews/meta-analyses of RCTs
  • RCTs
Other inclusion exclusion criteria

Exclude conference abstracts

Exclude studies from developing countries

Exclude studies where participants are women with sepsis

Proposed stratified, sensitivity/sub-group analysis, or meta-regressionSubgroup analyses (in case of heterogeneity):
  • Different modes of anaesthesia for caesarean birth (general anaesthesia/epidural anaesthesia/spinal anaesthesia/combined spinal epidural)
  • Women with significant blood loss (i.e. major obstetric haemorrhage)
  • Women with raised BMI
Selection process – duplicate screening/selection/analysisDuplicate screening/selection/analysis will not be undertaken for this review as this question was not prioritised for it. Included and excluded studies will be cross checked with the committee and with published systematic reviews when available.
Data management (software)

If pairwise meta-analyses are undertaken, they will be performed using Cochrane Review Manager (RevMan5).

‘GRADE’ will be used to assess the quality of evidence for each outcome.

STAR will be used for bibliographies/citations and study sifting.

Microsoft Word will be used for data extraction and quality assessment/critical appraisal

Information sources – databases and dates

Sources to be searched: Medline, Medline In-Process, CCTR, CDSR, and Embase.

Limits (e.g. date, study design): Study design limited to Systematic Reviews and RCTs. Apply standard animal/non-English language filters. No date limit.

Supplementary search techniques: No supplementary search techniques will be used.

Identify if an updateNo – this is a new review question to be added to the guideline.
Author contacts

Developer: National Guideline Alliance

KU.GRO.GOCR@seiriuqne-AGN

Highlight if amendment to previous protocolFor details please see section 4.5 of Developing NICE guidelines: the manual
Search strategy – for one databaseFor details please see appendix B
Data collection process – forms/duplicateA standardised evidence table format will be used, and published as appendix D (clinical evidence tables) or H (economic evidence tables)
Data items – define all variables to be collectedFor details please see evidence tables in appendix D (clinical evidence tables) or H (economic evidence tables)
Methods for assessing bias at outcome/study level

Appraisal of methodological quality:

The methodological quality of each study will be assessed using an appropriate checklist:

  • ROBIS for systematic reviews
  • Cochrane risk of bias tool for randomised studies
For details please see section 6.2 of Developing NICE guidelines: the manual

The risk of bias across all available evidence will evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group http://www​.gradeworkinggroup.org/

Criteria for quantitative synthesisFor details please see section 6.4 of Developing NICE guidelines: the manual
Methods for quantitative analysis – combining studies and exploring (in)consistency

Synthesis of data:

Meta-analysis will be conducted where appropriate using Review Manager.

Minimum important differences

Maternal temperature at different times.

In line with the NICE guideline on the prevention and management of hypothermia in adults having surgery, a difference of 0.5°C compared to the control group temperature is considered to be clinically significant for a control group temperature above 36°C and a difference of 0.20°C is considered to be clinically significant for control group temperatures below 36°C.

For other outcomes, default values will be used of: 0.8 and 1.25 for dichotomous outcomes; 0.5 times SD for continuous outcomes, unless more appropriate values are identified by the guideline committee or in the literature.

Meta-bias assessment – publication bias, selective reporting biasFor details please see section 6.2 of Developing NICE guidelines: the manual.
Confidence in cumulative evidenceFor details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual
Rationale/context – what is knownFor details please see the introduction to the evidence review
Describe contributions of authors and guarantor

A multidisciplinary committee developed the guideline. The committee was convened by the NGA and chaired by Sarah Fishburn in line with section 3 of Developing NICE guidelines: the manual.

Staff from the NGA undertook systematic literature searches, appraised the evidence, conducted meta-analysis and cost-effectiveness analysis where appropriate, and drafted the guideline in collaboration with the committee. For details please see the methods chapter of the full guideline.

Sources of funding/supportThe NGA is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists
Name of sponsorThe NGA is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists
Roles of sponsorNICE funds the NGA to develop guidelines for the NHS in England.
PROSPERO registration numberNot registered to PROSPERO

CDSR: Cochrane Database of Systematic Reviews; CENTRAL: Cochrane Central Register of Controlled Trials; DARE: Database of Abstracts of Reviews of Effects; GRADE: Grading of Recommendations Assessment, Development and Evaluation; HTA: Health Technology Assessment; NGA: National Guideline Alliance; NHS: National health service; NICE: National Institute for Health and Care Excellence; RCT: randomised controlled trial; RoB: risk of bias; SD: standard deviation

Appendix B. Literature search strategies

Literature search strategies for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

Review question search strategies
Databases: Medline; Medline EPub Ahead of Print; and Medline In-Process & Other Non-Indexed Citations

Date last searched: 22/11/2019

#Searches
1exp CESAREAN SECTION/
2(c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab.
3or/1–2
4HYPOTHERMIA/
5hypothermia?.ti,ab.
6SHIVERING/
7shiver$.ti,ab.
8or/4–7
93 and 8
10limit 9 to english language
11LETTER/
12EDITORIAL/
13NEWS/
14exp HISTORICAL ARTICLE/
15ANECDOTES AS TOPIC/
16COMMENT/
17CASE REPORT/
18(letter or comment*).ti.
19or/11–18
20RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab.
2119 not 20
22ANIMALS/ not HUMANS/
23exp ANIMALS, LABORATORY/
24exp ANIMAL EXPERIMENTATION/
25exp MODELS, ANIMAL/
26exp RODENTIA/
27(rat or rats or mouse or mice).ti.
28or/21–27
2910 not 28
Databases: Embase; and Embase Classic

Date last searched: 22/11/2019

#Searches
1exp CESAREAN SECTION/
2(c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab.
3or/1–2
4HYPOTHERMIA/
5hypothermia?.ti,ab.
6SHIVERING/
7shiver$.ti,ab.
8or/4–7
9and 8
10limit 9 to english language
11letter.pt. or LETTER/
12note.pt.
13editorial.pt.
14CASE REPORT/ or CASE STUDY/
15(letter or comment*).ti.
16or/11–15
17RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab.
1816 not 17
19ANIMAL/ not HUMAN/
20NONHUMAN/
21exp ANIMAL EXPERIMENT/
22exp EXPERIMENTAL ANIMAL/
23ANIMAL MODEL/
24exp RODENT/
25(rat or rats or mouse or mice).ti.
26or/18–25
2710 not 26
Databases: Cochrane Central Register of Controlled Trials; and Cochrane Database of Systematic Reviews

Date last searched: 22/11/2019

#Searches
#1MeSH descriptor: [CESAREAN SECTION] explode all trees
#2(cesarean* or caesarean* or “c section*” or csection* or (deliver* near/3 abdom*)):ti,ab
#3#1 or #2
#4MeSH descriptor: [HYPOTHERMIA] this term only
#5hypothermia*:ti,ab
#6MeSH descriptor: [SHIVERING] this term only
#7shiver*:ti,ab
#8#4 or #5 or #6 or #7
#9#3 and #8
Health economics search strategies
Databases: Medline; Medline EPub Ahead of Print; and Medline In-Process & Other Non-Indexed Citations

Date last searched: 22/11/2019

#Searches
1ECONOMICS/
2VALUE OF LIFE/
3exp “COSTS AND COST ANALYSIS”/
4exp ECONOMICS, HOSPITAL/
5exp ECONOMICS, MEDICAL/
6exp RESOURCE ALLOCATION/
7ECONOMICS, NURSING/
8ECONOMICS, PHARMACEUTICAL/
9exp “FEES AND CHARGES”/
10exp BUDGETS/
11budget*.ti,ab.
12cost*.ti,ab.
13(economic* or pharmaco?economic*).ti,ab.
14(price* or pricing*).ti,ab.
15(financ* or fee or fees or expenditure* or saving*).ti,ab.
16(value adj2 (money or monetary)).ti,ab.
17resourc* allocat*.ti,ab.
18(fund or funds or funding* or funded).ti,ab.
19(ration or rations or rationing* or rationed).ti,ab.
20ec.fs.
21or/1–20
22exp CESAREAN SECTION/
23(c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab.
24or/22–23
25HYPOTHERMIA/
26hypothermia?.ti,ab.
27SHIVERING/
28shiver$.ti,ab.
29or/25–28
3024 and 29
31limit 30 to english language
32LETTER/
33EDITORIAL/
34NEWS/
35exp HISTORICAL ARTICLE/
36ANECDOTES AS TOPIC/
37COMMENT/
38CASE REPORT/
39(letter or comment*).ti.
40or/32–39
41RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab.
4240 not 41
43ANIMALS/ not HUMANS/
44exp ANIMALS, LABORATORY/
45exp ANIMAL EXPERIMENTATION/
46exp MODELS, ANIMAL/
47exp RODENTIA/
48(rat or rats or mouse or mice).ti.
49or/42–48
5031 not 49
5121 and 50
Databases: Embase; and Embase Classic

Date last searched: 22/11/2019

#Searches
1HEALTH ECONOMICS/
2exp ECONOMIC EVALUATION/
3exp HEALTH CARE COST/
4exp FEE/
5BUDGET/
6FUNDING/
7RESOURCE ALLOCATION/
8budget*.ti,ab.
9cost*.ti,ab.
10(economic* or pharmaco?economic*).ti,ab.
11(price* or pricing*).ti,ab.
12(financ* or fee or fees or expenditure* or saving*).ti,ab.
13(value adj2 (money or monetary)).ti,ab.
14resourc* allocat*.ti,ab.
15(fund or funds or funding* or funded).ti,ab.
16(ration or rations or rationing* or rationed).ti,ab.
17or/1–16
18exp CESAREAN SECTION/
19(c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab.
20or/18–19
21HYPOTHERMIA/
22hypothermia?.ti,ab.
23SHIVERING/
24shiver$.ti,ab.
25or/21–24
2620 and 25
27limit 26 to english language
28letter.pt. or LETTER/
29note.pt.
30editorial.pt.
31CASE REPORT/ or CASE STUDY/
32(letter or comment*).ti.
33or/28–32
34RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab.
3533 not 34
36ANIMAL/ not HUMAN/
37NONHUMAN/
38exp ANIMAL EXPERIMENT/
39exp EXPERIMENTAL ANIMAL/
40ANIMAL MODEL/
41exp RODENT/
42(rat or rats or mouse or mice).ti.
43or/35–42
4427 not 43
4517 and 44
Database: Cochrane Central Register of Controlled Trials

Date last searched: 22/11/2019

#Searches
#1MeSH descriptor: [ECONOMICS] this term only
#2MeSH descriptor: [VALUE OF LIFE] this term only
#3MeSH descriptor: [COSTS AND COST ANALYSIS] explode all trees
#4MeSH descriptor: [ECONOMICS, HOSPITAL] explode all trees
#5MeSH descriptor: [ECONOMICS, MEDICAL] explode all trees
#6MeSH descriptor: [RESOURCE ALLOCATION] explode all trees
#7MeSH descriptor: [ECONOMICS, NURSING] this term only
#8MeSH descriptor: [ECONOMICS, PHARMACEUTICAL] this term only
#9MeSH descriptor: [FEES AND CHARGES] explode all trees
#10MeSH descriptor: [BUDGETS] explode all trees
#11budget*:ti,ab
#12cost*:ti,ab
#13(economic* or pharmaco?economic*):ti,ab
#14(price* or pricing*):ti,ab
#15(financ* or fee or fees or expenditure* or saving*):ti,ab
#16(value near/2 (money or monetary)):ti,ab
#17resourc* allocat*:ti,ab
#18(fund or funds or funding* or funded):ti,ab
#19(ration or rations or rationing* or rationed) .ti,ab.
#20#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19
#21MeSH descriptor: [CESAREAN SECTION] explode all trees
#22(cesarean* or caesarean* or “c section*” or csection* or (deliver* near/3 abdom*)):ti,ab
#23#21 or #22
#24MeSH descriptor: [HYPOTHERMIA] this term only
#25hypothermia*:ti,ab
#26MeSH descriptor: [SHIVERING] this term only
#27shiver*:ti,ab
#28#24 or #25 or #26 or #27
#29#23 and #28
#30#20 and #29

Appendix C. Clinical evidence study selection

Clinical study selection for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

Figure 1. Study selection flow chart.

Figure 1Study selection flow chart

Appendix D. Clinical evidence tables

Clinical evidence tables for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

Table 4. Clinical evidence tables for hypothermia and shivering (PDF, 995K)

Appendix E. Forest plots

Forest plots for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

This section includes forest plots only for outcomes that are meta-analysed. Outcomes from single studies are not presented here, but the quality assessment for these outcomes is provided in the GRADE profiles in appendix F.

Active warming measures versus control

Comparison 1. Warmed IV fluids versus control

Critical outcomes
1.1. Incidence of hypothermia.

1.1Incidence of hypothermia

1.2. Incidence of shivering.

1.2Incidence of shivering

1.3. Estimated blood loss.

1.3Estimated blood loss

Important outomes
1.5. Maternal (core) temperature change.

1.5Maternal (core) temperature change

1.6. Maternal temp (intra-op).

1.6Maternal temp (intra-op)

1.7. Maternal temp (post-op, baseline).

1.7Maternal temp (post-op, baseline)

1.8. Maternal temp (post-op, 30 mins).

1.8Maternal temp (post-op, 30 mins)

1.9. Maternal temp (post-op, recovery room, 45+ mins).

1.9Maternal temp (post-op, recovery room, 45+ mins)

1.10. Maternal temp (post-op, discharge/postpartum).

1.10Maternal temp (post-op, discharge/postpartum)

Comparison 2. Forced air warming versus control

Critical outcomes
2.1. Incidence of hypothermia.

2.1Incidence of hypothermia

2.2. Incidence of shivering.

2.2Incidence of shivering

2.3. Estimated blood loss.

2.3Estimated blood loss

Important outcomes
2.5. Maternal temp change (intra-op change).

2.5Maternal temp change (intra-op change)

2.6. Maternal temp (intra-op, within 30mins).

2.6Maternal temp (intra-op, within 30mins)

2.8. Maternal temp (intra-op, end of surgery).

2.8Maternal temp (intra-op, end of surgery)

2.10. Thermal comfort (pre-op).

2.10Thermal comfort (pre-op)

2.13. Thermal comfort (post-op).

2.13Thermal comfort (post-op)

Comparison 4. Warmed mattress/under-body pad versus control

Critical outcomes
4.1. Incidence of hypothermia.

4.1Incidence of hypothermia

4.3. Estimated blood loss.

4.3Estimated blood loss

Important outcomes
4.4. Maternal temp (intra-op).

4.4Maternal temp (intra-op)

4.5. Maternal temp (recovery room, baseline).

4.5Maternal temp (recovery room, baseline)

4.6. Maternal temp (post-op, recovery room).

4.6Maternal temp (post-op, recovery room)

Active warming measures versus other active warming

Comparison 7. Warmed mattress/under-body pad vs other warming

Critical outcomes
7.1. Incidence of hypothermia.

7.1Incidence of hypothermia

Important outcomes
7.3. Maternal temp (intra-op).

7.3Maternal temp (intra-op)

7.4. Maternal temp (post op, recovery room).

7.4Maternal temp (post op, recovery room)

Pharmacological therapy

Comparison 10. Opioid-like analgesic (pethidine) vs other opioid (morphine)

Critical outcomes
10.1. Incidence of shivering.

10.1Incidence of shivering

Comparison 11a. Opioid-like analgesic vs control for prevention

Critical outcomes
11a.1. Incidence of shivering.

11a.1Incidence of shivering

Appendix F. GRADE tables

GRADE tables for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

Active warming measures versus control

Comparison 1Warmed IV fluids versus control

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther consideratio nsWarmed IV fluidsControlRelative (95% CI)Absolute
Incidence of hypothermia (<36 C) - Maintained warming (37–42 C)
2 (Paris 2014; Smith 2000)randomised trialsvery serious1serious2no serious indirectnessvery serious3none

30/108

(27.8%)

36/108

(33.3%)

RR 0.81 (0.4 to 1.64)63 fewer per 1000 (from 200 fewer to 213 more)VERY LOWCRITICAL
Incidence of shivering
6 (Chan 1989; Chung 2012; Jorgensen 2000; Smith 2000; Woolnough 2009; Workhoven 1986)randomised trialsvery serious4no serious inconsistencyno serious indirectnessno serious imprecisionnone

51/200

(25.5%)

70/169

(41.4%)

RR 0.59 (0.44 to 0.8)170 fewer per 1000 (from 83 fewer to 232 fewer)LOWCRITICAL
SUBGROUP: Incidence of shivering - Maintained warming (37–42 C)
3 (Jorgensen 2000; Smith 2000; Woolnough 2009)randomised trialsvery serious4no serious inconsistencyno serious indirectnessserious5none

35/142

(24.6%)

35/113

(31%)

RR 0.74 (0.5 to 1.1)81 fewer per 1000 (from 155 fewer to 31 more)VERY LOWCRITICAL
SUBGROUP: Incidence of shivering - Pre-warmed only (37–42 C)
1 (Chung 2012)randomised trialsvery serious6no serious inconsistencyno serious indirectnessserious5none

2/15

(13.3%)

8/15

(53.3%)

RR 0.25 (0.06 to 0.99)400 fewer per 1000 (from 5 fewer to 501 fewer)VERY LOWCRITICAL
SUBGROUP: Incidence of shivering - Pre-warmed only (30–34 C)
1 (Workhoven 1986)randomised trialsvery serious6,7no serious inconsistencyno serious indirectnessno serious imprecisionnone

3/22

(13.6%)

14/22

(63.6%)

RR 0.21 (0.07 to 0.64)503 fewer per 1000 (from 229 fewer to 592 fewer)LOWCRITICAL
SUBGROUP: Incidence of shivering - Maintained (36.5 C) plus blankets
1 (Chan 1989)randomised trialsvery serious6no serious inconsistencyno serious indirectnessvery serious3none

11/21

(52.4%)

13/19

(68.4%)

RR 0.77 (0.46 to 1.27)157 fewer per 1000 (from 369 fewer to 185 more)VERY LOWCRITICAL
Estimated blood loss (Better indicated by lower values)
4 (Chan 1989; Chung 2012; Paris 2014; Yokoyama 2009)randomised trialsvery serious4no serious inconsistencyno serious indirectnessno serious imprecision8none124125-MD 9.55 higher (35.11 lower to 54.22 higher)LOWCRITICAL
SUBGROUP: Estimated blood loss - Maintained warming (37–42 C) (Better indicated by lower values)
1 (Paris 2014)randomised trialsvery serious7no serious inconsistencyno serious indirectnessno serious imprecision8none7376-MD 42.2 higher (15.24 lower to 99.64 higher)LOWCRITICAL
SUBGROUP: Estimated blood loss - Pre-warmed only (37–42 C) (Better indicated by lower values)
2 (Chung 2012; Yokoyama 2009)randomised trialsserious9no serious inconsistencyno serious indirectnessno serious imprecision8none3030-MD 45.31 lower (131.67 lower to 41.04 higher)MODERATECRITICAL
SUBGROUP: Estimated blood loss - Maintained (36.5 C) plus blankets (Better indicated by lower values)
1 (Chan 1989)randomised trialsvery serious6no serious inconsistencyno serious indirectnessserious8,10none2119-MD 30 lower (154.85 lower to 94.85 higher)VERY LOWCRITICAL
Estimated blood loss (need for blood products)
1 (Smith 2000)randomised trialsvery serious6no serious inconsistencyno serious indirectnessvery serious11none

0/35

(0%)

0/32

(0%)

See comment120 more per 1000 (from 60 fewer to 60 more)16VERY LOWCRITICAL
Maternal (core) temperature change (Better indicated by higher values)
2 (Chan 1989; Chung 2012)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision8none3634-MD 0.4 higher (0.36 to 0.44 higher)LOWIMPORTANT
Maternal temp (intraoperative) (Better indicated by higher values)
3 (Paris 2014; Smith 2000; Yokoyama 2009)randomised trialsvery serious5very serious14no serious indirectnessserious8,15none123123-MD 0.36 higher (0.09 to 0.64 higher)VERY LOWIMPORTANT
Maternal temp (post-op, baseline) (Better indicated by higher values)
2 (Smith 2000; Yokoyama 2009)randomised trialsno serious risk of biasvery serious16no serious indirectnessno serious imprecision8none5047-MD 0.61 higher (0.22 to 1 higher)LOWIMPORTANT
Maternal temp (post-op, 30mins) (Better indicated by higher values)
2 (Smith 2000; Yokoyama 2009)randomised trialsserious9very serious16no serious indirectnessno serious imprecision8none5047-MD 0.71 higher (0.32 to 1.1 higher)VERY LOWIMPORTANT
Maternal temp (post-op, recovery room, 45mins+) (Better indicated by higher values)
3 (Paris 2014; Smith 2000; Yokoyama 2009)randomised trialsvery serious4very serious17no serious indirectnessserious8,18none123123-MD 0.51 higher (0.05 to 0.96 higher)VERY LOWIMPORTANT
Maternal temp (post-op, discharge/postpartum) (Better indicated by higher values)
2 (Paris 2014; Smith 2000)randomised trialsvery serious1very serious19no serious indirectnessserious8,20none108108-MD 0.68 higher (0.16 to 1.2 higher)VERY LOWIMPORTANT
Thermal comfort (Better indicated by higher values)
1 (Chung 2012)randomised trialsvery serious6no serious inconsistencyno serious indirectnessserious8,21none1515-MD 10 higher (0.11 lower to 20.11 higher)VERY LOWIMPORTANT
Thermal comfort <4
1 (Woolnough 2009)randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessno serious imprecisionnone

4/50

(8%)

8/25

(32%)

RR 0.25 (0.08 to 0.75)240 fewer per 1000 (from 80 fewer to 294 fewer)HIGHIMPORTANT
Thermal comfort >6
1 (Woolnough 2009)randomised trialsno serious risk of biasno serious inconsistencyno serious indirectnessvery serious3none

20/50

(40%)

8/25

(32%)

RR 1.25 (0.64 to 2.43)80 more per 1000 (from 115 fewer to 458 more)LOWIMPORTANT
1

High ROB in 2+ domains or unclear ROB in 4+ domains in each study

2

i2=67% (using random effects model)

3

95%CI crosses two MID boundaries (0.8 to 1.25)

4

High and unclear ROB in majority of studies

5

95%CI crosses one MID boundary (0.8 to 1.25)

6

Unclear ROB in 4+ domains

7

High ROB in 2+ domains

8

MID = +/-0.5*SD in control group

9

Unclear ROB in 4+ domains in one study, low ROB in one study

10

95%CI crosses one MID boundary (+/-102)

11

OIS<300: No relative measure CI for assessment, sample size <300

12

risk difference calculated as zero cases in each group

13

absolute effect calculated from risk difference

14

i2=83% (using random effects model)

15

95%CI crosses one MID boundary (+/-0.20)

16

i2=80% (using random effects model)

17

i2=94% (using random effects model)

18

95%CI crosses one MID boundary (+/-0.22)

19

i2=90% (using random effects model)

20

95%CI crosses one MID boundary (+/-0.29)

21

95%CI crosses one MID boundary (+/-8)

Comparison 2Forced air warming versus control

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsForced air warmingControlRelative (95% CI)Absolute
Incidence of hypothermia
3 (Butwick 2007; Chebbout 2017; Horn 2014)randomised trialsvery serious1very serious2no serious indirectnessvery serious3none

9/77

(11.7%)

20/80

(25%)

RR 0.35 (0.03 to 3.56)162 fewer per 1000 (from 243 fewer to 640 more)VERY LOWCRITICAL
SUBGROUP: Incidence of hypothermia – both groups had no additional warming (other than intervention)
2 (Butwick 2007; Horn 2014)randomised trialsvery serious1very serious2no serious indirectnessvery serious3none

9/34

(26.5%)

20/36

(55.6%)

RR 0.35 (0.03 to 3.56)361 fewer per 1000 (from 539 fewer to 1000 more)VERY LOWCRITICAL
SUBGROUP: Incidence of hypothermia – both control and intervention groups also had maintained warmed IV fluids (41 C)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious4none

0/43

(0%)

0/44

(0%)

Not estimable50 more per 1000 (from 40 fewer to 40 more)6VERY LOWCRITICAL
Incidence of shivering
6 (Butwick 2007; Chung 2012; Fallis 2006; Horn 2002; Horn 2014; Munday 2018)randomised trialsvery serious7no serious inconsistencyno serious indirectnessno serious imprecisionnone

22/121

(18.2%)

47/121

(38.8%)

RR 0.47 (0.3 to 0.72)206 fewer per 1000 (from 109 fewer to 272 fewer)LOWCRITICAL
Estimated blood loss (Better indicated by lower values)
3 (Butwick 2007; Chung 2012; Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision8none7374-MD 11.23 higher (42.26 lower to 64.71 higher)LOWCRITICAL
SUBGROUP: Estimated blood loss – no additional warming (Better indicated by lower values)
2 (Butwick 2007; Chung 2012)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious8,9none3030-MD 41.8 higher (28.78 lower to 112.38 higher)VERY LOWCRITICAL
SUBGROUP: Estimated blood loss – both groups also with maintained warmed IV fluids (41 C) (Better indicated by lower values)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious8,10none4344-MD 30 lower (111.96 lower to 51.96 higher)VERY LOWCRITICAL
Maternal temperature change (peri-op change) (Better indicated by lower values)
1 (Butwick 2007)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious8,11none1515-MD 0 higher (0.25 lower to 0.25 higher)VERY LOWIMPORTANT
Maternal temperature change (intra-op change) (Better indicated by lower values)
3 (Chung 2012; Fallis 2006; Munday 2018)randomised trialsvery serious7very serious12no serious indirectnessserious8,13none7270-MD 0.06 higher (0.21 lower to 0.33 higher)VERY LOWIMPORTANT
Maternal temperature (intra-op, within 30mins) (Better indicated by higher values)
2 (Chebbout 2017; Horn 2014)randomised trialsvery serious1very serious12no serious indirectnessserious8,14none6265-MD 0.11 lower (0.4 lower to 0.17 higher)VERY LOWIMPORTANT
Maternal temperature (intra-op, immediately post-delivery) (Better indicated by higher values)
1 (Horn 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious8,15none1921-MD 0.1 lower (0.38 lower to 0.18 higher)VERY LOWIMPORTANT
Maternal temperature (intra-op, end of surgery) (Better indicated by higher values)
4 (Chebbout 2017; Fallis 2006; Horn 2002; Horn 2014)randomised trialsvery serious1very serious16no serious indirectnessserious8,17none109110-MD 0.4 higher (0.01 to 0.8 higher)VERY LOWIMPORTANT
Maternal temperature (post-op, recovery room, 15mins) (Better indicated by higher values)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious8,18none4344-MD 0.1 higher (0.02 to 0.18 higher)VERY LOWIMPORTANT
Thermal comfort (pre-op) (Better indicated by higher values)
2 (Horn 2002; Horn 2014)randomised trialsvery serious1serious19no serious indirectnessserious8,20none3436-MD 6.46 higher (2.2 to 10.73 higher)VERY LOWIMPORTANT
Thermal comfort (intra-op, immediately post-delivery) (Better indicated by higher values)
1 (Horn 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious8,21none1921-MD 8 higher (1.37 to 14.63 higher)VERY LOWIMPORTANT
Thermal comfort (intra-op, end of surgery) (Better indicated by higher values)
1 (Horn 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision8none1921-MD 16 higher (9.79 to 22.21 higher)LOWIMPORTANT
Thermal comfort (post-op) (Better indicated by higher values)L
3 (Butwick 2007; Chung 2012; Munday 2018)randomised trialsvery serious7no serious inconsistencyno serious indirectnessno serious imprecision8none5555-MD 0.23 higher (0.17 lower to 0.63 higher)LOWIMPORTANT
SUBGROUP: Thermal comfort (post-op) - post-op, recovery room, discharge (Better indicated by higher values)
2 (Butwick 2007; Chung 2012)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious8,22none3030-MD 3.28 higher (0.98 lower to 7.54 higher)VERY LOWIMPORTANT
SUBGROUP: Thermal comfort (post-op) - peri-operative (Better indicated by higher values)
1 (Munday 2018)randomised trialsvery serious23no serious inconsistencyno serious indirectnessserious8,24none2525-MD 0.2 higher (0.2 lower to 0.6 higher)VERY LOWIMPORTANT
Wound infection
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious3none

1/43

(2.3%)

3/44

(6.8%)

RR 0.34 (0.04 to 3.15)45 fewer per 1000 (from 65 fewer to 147 more)VERY LOWIMPORTANT
1

Unclear ROB in 4 (or more) domains in each study

2

i2=81% (using random effects model)

3

95%CI crosses two MID boundaries (0.8 to 1.25)

4

OIS<300: No relative measure CI for assessment, sample size <300

5

risk difference calculated due to zero cases in both arms

6

absolute effect calculated from risk difference

7

High ROB in 2 domains in one (or more) studies, unclear in 4+ domains in 2 (or more) studies

8

MID = +/- 0.5*SD in control group

9

95%CI crosses one MID boundary (+/-58.75)

10

95%CI crosses one MID boundary (+/-100)

11

95%CI crosses two MID boundaries (+/-0.15)

12

i2=70% (using random effects model)

13

95%CI crosses one MID boundary (+/-0.245)

14

95%CI crosses one MID boundary (+/-0.175)

15

95%CI cross one MID boundary (+/-0.25)

16

i2=94% (using random effects model)

17

95%CI crosses one MID boundary (+/-0.2)

18

95%CI crosses one MID boundary (+/-0.1)

19

i2=58%

20

95%CI crosses one MID boundary (+/-4.25)

21

95%CI crosses one MID boundary (+/-4.5)

22

95%CI crosses one MID boundary (+/-5.48)

23

High ROB in 2 domains

24

95%CI crosses on MID boundary (+/-0.37)

Comparison 3Forced air warming (FAW) + warmed IV fluid versus control

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsFAW + warmed IV fluidControlRelative (95% CI)Absolute
Incidence of hypothermia (peri-op)
1 (Cobb 2016)randomised trialsno serious risk of bias1no serious inconsistencyno serious indirectnessserious2none

14/22

(63.6%)

20/22

(90.9%)

RR 0.7 (0.5 to 0.99)273 fewer per 1000 (from 9 fewer to 455 fewer)MODERATECRITICAL
Incidence of shivering (intra-op)
1 (Cobb 2016)randomised trialsno serious risk of bias1no serious inconsistencyno serious indirectnessserious2none

5/22

(22.7%)

10/22

(45.5%)

RR 0.5 (0.2 to 1.23)227 fewer per 1000 (from 364 fewer to 105 more)MODERATECRITICAL
Incidence of shivering (post-op)
1 (Cobb 2016)randomised trialsno serious risk of bias1no serious inconsistencyno serious indirectnessvery serious3none

4/22

(18.2%)

4/22

(18.2%)

RR 1 (0.29 to 3.5)0 fewer per 1000 (from 129 fewer to 455 more)LOWCRITICAL
Estimated blood loss4 (Better indicated by lower values)
1 (Cobb 2016)randomised trialsno serious risk of bias1no serious inconsistencyno serious indirectnessvery serious5none

22

median [IQR] 950 [800–1000] mL

22

median [IQR] 975 [800–1000] mL

-4median diff 25 lower4LOWCRITICAL
Maternal temperature (intra-op, recovery room, baseline) (Better indicated by higher values)
1 (Cobb 2016)randomised trialsno serious risk of bias1no serious inconsistencyno serious indirectnessserious6,7none2222-MD 0.4 higher (0.1 to 0.7 higher)MODERATEIMPORTANT
Thermal comfort (post-op, recovery room, discharge)4 (Better indicated by higher values)
1 (Cobb 2016)randomised trialsno serious risk of bias1no serious inconsistencyno serious indirectnessvery serious5none

22

median [IQR] 100 [95–100]

22

median [IQR] 90 [70–100]

-4median difference 10 higher4LOWIMPORTANT
1

Unclear ROB in one domain

2

95%CI crosses one MID (0.8 to 1.25)

3

95%CI crosses two MIDs (0.8 to 1.25)

4

effect could not be calculated

5

OIS<300: No relative measure CI for assessment, sample size <300

6

95%CI crosses on MID (+/- 0.25)

7

MID = +/-0.5*SD in control group

Comparison 4Warmed mattress/under-body pad versus control

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsWarmed mattress/under-body padControlRelative (95% CI)Absolute
Incidence of hypothermia
3 (Chakladar 2014; Chebbout 2017; Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2none

13/179

(7.3%)

23/178

(12.9%)

RR 0.56 (0.3 to 1.06)57 fewer per 1000 (from 90 fewer to 8 more)VERY LOWCRITICAL
SUBGROUP: Incidence of hypothermia - undefined time point
2 (Chakladar 2014; Chebbout 2017)randomised trialsserious3no serious inconsistencyno serious indirectnessserious2none

3/102

(2.9%)

11/102

(10.8%)

RR 0.27 (0.08 to 0.93)79 fewer per 1000 (from 8 fewer to 99 fewer)LOWCRITICAL
SUBGROUP: Incidence of hypothermia – postpartum
1 (Paris 2014)randomised trialsvery serious4no serious inconsistencyno serious indirectnessvery serious5none

10/77

(13%)

12/76

(15.8%)

RR 0.82 (0.38 to 1.79)28 fewer per 1000 (from 98 fewer to 125 more)VERY LOWCRITICAL
Incidence of shivering
1 (Chakladar 2014)randomised trialsserious6no serious inconsistencyno serious indirectnessvery serious5none

10/58

(17.2%)

8/58

(13.8%)

RR 1.25 (0.53 to 2.94)34 more per 1000 (from 65 fewer to 268 more)VERY LOWCRITICAL
Estimated blood loss (Better indicated by lower values)
2 (Chebbout 2017; Paris 2014)randomised trialsvery serious7no serious inconsistencyno serious indirectnessno serious imprecision8none121120-MD 0.41 lower (56.12 lower to 55.3 higher)LOWCRITICAL
Maternal temperature (intra-op) (Better indicated by higher values)
3 (Chakladar 2014; Chebbout 2017; Paris 2014)randomised trialsvery serious1serious9no serious indirectnessno serious imprecision8none179178-MD 0.06 higher (0.01 to 0.12 higher)VERY LOWIMPORTANT
SUBGROUP: Maternal temperature (intra-op) - start/first 30mins (Better indicated by higher values)
2 (Chakladar 2014; Chebbout 2017)randomised trialsserious3no serious inconsistencyno serious indirectnessno serious imprecision8none102102-MD 0.03 higher (0.04 lower to 0.1 higher)MODERATEIMPORTANT
SUBGROUP: Maternal temperature (intra-op) - anytime in operating room (Better indicated by higher values)
1 (Paris 2014)randomised trialsvery serious4no serious inconsistencyno serious indirectnessserious8,10none7776-MD 0.12 higher (0.03 to 0.21 higher)VERY LOWIMPORTANT
Maternal temperature (intra-op, recovery room, baseline) (Better indicated by higher values)
2 (Chakladar 2014; Chebbout 2017)randomised trialsserious3very serious11no serious indirectnessserious8,12none102102-MD 0.09 higher (0.11 lower to 0.28 higher)VERY LOWIMPORTANT
Maternal temperature (post-op, recovery room) (Better indicated by higher values)
2 (Chebbout 2017; Paris 2014)randomised trialsvery serious7very serious13no serious indirectnessserious8,14none121120-MD 0.16 higher (0.16 lower to 0.48 higher)VERY LOWIMPORTANT
Maternal temperature (post-op, postpartum) (Better indicated by higher values)
1 (Paris 2014)randomised trialsvery serious4no serious inconsistencyno serious indirectnessno serious imprecision8none7776-MD 0.98 higher (0.81 to 1.15 higher)LOWIMPORTANT
Wound infection
1 (Chebbout 2017)randomised trialsvery serious15no serious inconsistencyno serious indirectnessvery serious5none

2/44

(4.5%)

3/44

(6.8%)

RR 0.67 (0.12 to 3.8)22 fewer per 1000 (from 60 fewer to 191 more)VERY LOWIMPORTANT
1

High ROB in at least 2 domains in one study, unclear ROB in at least 2 domains in two studies

2

95%CI crosses one MID (0.8 to 1.25)

3

Unclear ROB in at least 2 domains in both studies

4

High ROB in 3 domains, unclear in one domain

5

95%CI crosses two MIDs (0.8 to 1.25)

6

Unclear ROB in 2 domains

7

High ROB in 2+ domains in one study, unclear in 4 domains in one study

8

MID = +/- 0.5*SD in control group

9

i2=56%

10

95%CI crosses one MID boundary (+/- 0.18)

11

i2=78% (with random effects model)

12

95%CI crosses one MID boundary (+/-0.15)

13

i2=94% (with random effects model)

14

95%CI crosses one MID boundary (+/-0.16)

15

Unclear ROB in 4 domains

ACTIVE WARMING MEASURES VERSUS OTHER ACTIVE WARMING

Comparison 5Forced air warming versus warmed IV fluids

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsForced air warmingWarmed IV fluidsRelative (95% CI)Absolute
Incidence of shivering
1 (Chung 2012)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2none

3/15

(20%)

2/15

(13.3%)

RR 1.5 (0.29 to 7.73)67 more per 1000 (from 95 fewer to 897 more)VERY LOWCRITICAL
Estimated blood loss (Better indicated by lower values)
1 (Chung 2012)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious3,4none1515-MD 80 higher (20.2 lower to 180.2 higher)VERY LOWCRITICAL
Maternal temperature change (intra-op, 45 minutes after intervention) (Better indicated by higher values)
1 (Chung 2012)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious3,5none1515-MD 0.1 lower (0.35 lower to 0.15 higher)VERY LOWIMPORTANT
Thermal comfort (Better indicated by higher values)
1 (Chung 2012)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious3,6none1515-MD 0.3 lower (9.36 lower to 8.76 higher)VERY LOWIMPORTANT
1

Unclear ROB in 6 domains

2

95%CI crosses two MID boundaries (0.8 to 1.25)

3

MID = +/-0.5*SD in control group

4

95%CI crosses one MID boundary (+/-70)

5

95%CI crosses one MID boundary (+/-0.15)

6

95%CI crosses two MID boundaries (+/- 6.05)

Comparison 6Forced air warming versus mattress warming

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsForced air warmingMattress warmingRelative (95% CI)Absolute
Incidence of hypothermia (<36 C)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2none

0/43

(0%)

0/44

(0%)

See comment30 more per 1000 (from 40 fewer to 40 more)4VERY LOWCRITICAL
Estimated blood loss (Better indicated by lower values)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision5none4344-MD 20 lower (110.85 lower to 70.85 higher)LOWCRITICAL
Maternal temperature (pre-op, 15 minutes after anaesthetic) (Better indicated by higher values)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision5none4344-MD 0 higher (0.08 lower to 0.08 higher)LOWIMPORTANT
Maternal temperature (intra-op, recovery room, baseline) (Better indicated by higher values)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision5none4344-MD 0 higher (0.08 lower to 0.08 higher)LOWIMPORTANT
Maternal temperature (post-op, recovery room, 15 min) (Better indicated by higher values)
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious5,6none4344-MD 0.1 higher (0.02 to 0.18 higher)VERY LOWIMPORTANT
Wound infection
1 (Chebbout 2017)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious7none

1/43

(2.3%)

2/44

(4.5%)

RR 0.51 (0.05 to 5.44)22 fewer per 1000 (from 43 fewer to 202 more)VERY LOWIMPORTANT
1

Unclear ROB in 4 domains

2

OIS<300: No relative measure CI for assessment, sample size <300

3

risk difference calculated due to zero cases in both arms

4

absolute effect calculated from risk difference

5

MID = +/- 0.5*SD in control group

6

95%CI crosses one MID boundary (+/-0.1)

7

95%CI crosses two MID boundaries (0.8 to 1.25)

Comparison 7Warmed mattress/under body pad versus other warming CLUSTER

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsWarmed mattress/under body padOther warmingRelative (95% CI)Absolute
Incidence of hypothermia
2 (Grant 2015; Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2,3none

98/208

(47.1%)

119/204

(58.3%)

RR 0.82 (0.7 to 0.96)105 fewer per 1000 (from 23 fewer to 175 fewer)VERY LOWCRITICAL
SUBGROUP: Incidence of hypothermia - Warmed IV fluids, tinfoil hats, warmed blankets
1 (Grant 2015)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2,3none

88/131

(67.2%)

105/131

(80.2%)

RR 0.84 (0.72 to 0.97)128 fewer per 1000 (from 24 fewer to 224 fewer)VERY LOWCRITICAL
SUBGROUP: Incidence of hypothermia - Warmed IV fluids (maintained)
1 (Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious4none

10/77

(13%)

14/73

(19.2%)

RR 0.68 (0.32 to 1.43)61 fewer per 1000 (from 130 fewer to 82 more)VERY LOWCRITICAL
Estimated blood loss - Warmed IV fluids (maintained) (Better indicated by lower values)
1 (Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious5,6none7773-MD 37.11 lower (101.5 lower to 27.28 higher)VERY LOWCRITICAL
Maternal temperature (intra-op) (Better indicated by higher values)
2 (Grant 2015; Paris 2014)randomised trialsvery serious1very serious7no serious indirectnessvery serious2,5,8none208204-MD 0.08 higher (0.14 lower to 0.31 higher)VERY LOWIMPORTANT
SUBGROUP: Maternal temperature (intra-op) - Warmed IV fluids, tinfoil hats, warmed blankets (Better indicated by higher values)
1 (Grant 2015)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2,5,9none131131-MD 0.2 higher (0.08 to 0.32 higher)VERY LOWIMPORTANT
SUBGROUP: Maternal temperature (intra-op) - Warmed IV fluids (maintained) (Better indicated by higher values)
1 (Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision5none7773-MD 0.03 lower (0.12 lower to 0.06 higher)LOWIMPORTANT
Maternal temperature (post-op, recovery room) (Better indicated by higher values)
2 (Grant 2015; Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2,5none320314-MD 0.05 higher (0.03 lower to 0.13 higher)VERY LOWIMPORTANT
SUBGROUP: Maternal temperature (post-op, recovery room) - Warmed IV fluids, tinfoil hats, warmed blankets (Better indicated by higher values)
1 (Grant 2015)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2,5none243241-MD 0 higher (0.11 lower to 0.11 higher)VERY LOWIMPORTANT
SUBGROUP: Maternal temperature (post-op, recovery room) - Warmed IV fluids (maintained) (Better indicated by higher values)
1 (Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious5,10none7773-MD 0.11 higher (0.01 lower to 0.23 higher)VERY LOWIMPORTANT
Maternal temperature (post-op, postpartum) - Warmed IV fluids (maintained) (Better indicated by higher values)
1 (Paris 2014)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision5none7773-MD 0.05 higher (0.1 lower to 0.2 higher)LOWIMPORTANT
Wound infection - Warmed IV fluids, tinfoil hats, warmed blankets
1 (Grant 2015)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2,4none

4/243

(1.6%)

1/241

(0.41%)

RR 3.97 (0.45 to 35.24)12 more per 1000 (from 2 fewer to 142 more)VERY LOWIMPORTANT
1

High ROB in at least 2 domains per study

2

Downgraded once for cluster RCT with insufficient information available for design effect adjustment

3

95%CI crosses one MID (0.8 to 1.25)

4

95%CI crosses two MIDs (0.8 to 1.25)

5

MID = +/- 0.5*SD in control group

6

95%CI crosses one MID boundary (+/-78)

7

i2=89% (with random effects model)

8

95%CI crosses one MID boundary (+/-0.2)

9

95%CI crosses one MID boundary (+/-0.25)

10

95%CI crosses one MID boundary (+/-0.18)

Thermal insulation measures

Comparison 8Higher versus lower ambient temperature

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsHigher ambient temperatureLower ambient temperatureRelative (95% CI)Absolute
Incidence of hypothermia <36 C
1 (Duryea 2016)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2,3none

104/390

(26.7%)

132/401

(32.9%)

RR 0.81 (0.65 to 1.01)63 fewer per 1000 (from 115 fewer to 3 more)VERY LOWCRITICAL
Wound infection
1 (Duryea 2016)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2,4none

0/390

(0%)

1/401

(0.25%)

POR 0.14 (0.00 to 7.01)2 fewer per 1000 (from 2 fewer to 15 more)VERY LOWIMPORTANT
1

High ROB in 4 domains

2

Downgraded once for cluster RCT with insufficient information available for design effect adjustment

3

95%CI crosses one MID (0.8 to 1.25)

4

95%CI crosses two MIDs (0.8 to 1.25)

Pharmacological therapy

Comparison 95-HT3 antagonist versus control

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerations5-HT3 antagonistControlRelative (95% CI)Absolute
Incidence of shivering
1 (Browning 2013)randomised trialsserious1no serious inconsistencyno serious indirectnessvery serious2none

23/56

(41.1%)

28/60

(46.7%)

RR 0.88 (0.58 to 1.33)56 fewer per 1000 (from 196 fewer to 154 more)VERY LOWCRITICAL
Incidence of shivering (reached score 2–4)
1 (Browning 2013)randomised trialsserious1no serious inconsistencyno serious indirectnessvery serious2none

18/56

(32.1%)

20/60

(33.3%)

RR 0.96 (0.57 to 1.63)13 fewer per 1000 (from 143 fewer to 210 more)VERY LOWCRITICAL
1

High ROB in one domain, unclear in one domain

2

95%CI crosses two MID boundaries (0.8 to 1.25)

Comparison 10Opioid-like analgesic (pethidine) versus other opioid (morphine)

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsOpioid-like analgesic (pethidine)Other opioid (morphine)Relative (95% CI)Absolute
Incidence of shivering
1 (Hong 2005)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2none

2/60

(3.3%)

9/59

(15.3%)

RR 0.22 (0.05 to 0.97)119 fewer per 1000 (from 5 fewer to 145 fewer)VERY LOWCRITICAL
SUBGROUP: Incidence of shivering - peth (10mg) vs morphine (0.1mg)
1 (Hong 2005)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious3none

1/30

(3.3%)

5/29

(17.2%)

RR 0.19 (0.02 to 1.56)140 fewer per 1000 (from 169 fewer to 97 more)VERY LOWCRITICAL
SUBGROUP: Incidence of shivering - peth (10mg) vs morphine (0.2mg)
1 (Hong 2005)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious3none

1/30

(3.3%)

4/30

(13.3%)

RR 0.25 (0.03 to 2.11)100 fewer per 1000 (from 129 fewer to 148 more)VERY LOWCRITICAL
1

Unclear ROB in 5 domains

2

95%CI crosses one MID boundary (0.8 to 1.25)

3

95%CI crosses two MID boundaries (0.8 to 1.25)

Comparison 11aOpioid-like analgesic versus control FOR PREVENTION

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsOpioid-like analgesicControlRelative (95% CI)Absolute
Incidence of shivering
3 (Hong 2005; Roy 2004; Sutherland 1991)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

24/156

(15.4%)

55/157

(35%)

RR 0.44 (0.29 to 0.66)196 fewer per 1000 (from 119 fewer to 249 fewer)LOWCRITICAL
SUBGROUP: Incidence of shivering - pethidine (25mg)
1 (Sutherland 1991)randomised trialsvery serious2no serious inconsistencyno serious indirectnessno serious imprecisionnone

5/47

(10.6%)

17/47

(36.2%)

RR 0.29 (0.12 to 0.73)257 fewer per 1000 (from 98 fewer to 318 fewer)LOWCRITICAL
SUBGROUP: Incidence of shivering - pethidine (10mg)
1 (Hong 2005)randomised trialsvery serious2no serious inconsistencyno serious indirectnessserious3none

1/30

(3.3%)

7/30

(23.3%)

RR 0.14 (0.02 to 1.09)201 fewer per 1000 (from 229 fewer to 21 more)VERY LOWCRITICAL
SUBGROUP: Incidence of shivering - meperidine (0.2mg/kg)
1 (Roy 2004)randomised trialsserious4no serious inconsistencyno serious indirectnessserious3none

9/20

(45%)

17/20

(85%)

RR 0.53 (0.32 to 0.89)400 fewer per 1000 (from 94 fewer to 578 fewer)LOWCRITICAL
SUBGROUP: Incidence of shivering - morphine (0.1mg)
1 (Hong 2005)randomised trialsvery serious2no serious inconsistencyno serious indirectnessvery serious5none

5/29

(17.2%)

7/30

(23.3%)

RR 0.74 (0.26 to 2.07)61 fewer per 1000 (from 173 fewer to 250 more)VERY LOWCRITICAL
SUBGROUP: Incidence of shivering - morphine (0.2mg)
1 (Hong 2005)randomised trialsvery serious2no serious inconsistencyno serious indirectnessvery serious5none

4/30

(13.3%)

7/30

(23.3%)

RR 0.57 (0.19 to 1.75)100 fewer per 1000 (from 189 fewer to 175 more)VERY LOWCRITICAL
1

Unclear ROB in 5 domains in 2 studies, high ROB in one domain and unclear in one domain in one study

2

Unclear ROB in 5 domains

3

95%CI crosses one MID (0.8 to 1.25)

4

High ROB in one domain, unclear in one domain

5

95%CI crosses two MIDs (0.8 to 1.25)

Comparison 11bOpioid-like analgesic (Pethidine) versus control FOR MANAGEMENT

Quality assessmentNo of patientsEffectQualityImportance
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsOpioid-like analgesic (Meperidine)ControlRelative (95% CI)Absolute
Incidence of shivering (2 mins post infusion)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

8/20

(40%)

19/20

(95%)

RR 0.42 (0.24 to 0.73)551 fewer per 1000 (from 256 fewer to 722 fewer)LOWCRITICAL
Incidence of shivering (5 mins post infusion)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

5/20

(25%)

15/20

(75%)

RR 0.33 (0.15 to 0.74)502 fewer per 1000 (from 195 fewer to 637 fewer)LOWCRITICAL
Incidence of shivering (15mins post)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

3/20

(15%)

17/20

(85%)

RR 0.18

(0.06 to 0.51)

697 fewer per 1000 (from 417 fewer to 799 fewer)LOWCRITICAL
Incidence of shivering (30 mins post)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

6/20

(30%)

18/20

(90%)

RR 0.33 (0.17 to 0.66)603 fewer per 1000 (from 306 fewer to 747 fewer)LOWCRITICAL
Incidence of shivering (60 mins post)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecisionnone

5/20

(25%)

14/20

(70%)

RR 0.36 (0.16 to 0.8)448 fewer per 1000 (from 140 fewer to 588 fewer)LOWCRITICAL
Maternal core temp (2mins post) (Better indicated by higher values)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessvery serious2,3none2020-MD 0 higher (0.12 lower to 0.12 higher)VERY LOWIMPORTANT
Maternal core temp (5mins post) (Better indicated by higher values)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessserious2,4none2020-MD 0.1 lower (0.26 lower to 0.06 higher)VERY LOWIMPORTANT
Maternal core temp (15mins post) (Better indicated by higher values)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision2none2020-MD 0.3 lower (0.42 to 0.18 lower)LOWIMPORTANT
Maternal core temp (30mins post) (Better indicated by higher values)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision2none2020-MD 0.5 lower (0.62 to 0.38 lower)LOWIMPORTANT
Maternal core temp (60mins post) (Better indicated by higher values)
1 (Casey 1988)randomised trialsvery serious1no serious inconsistencyno serious indirectnessno serious imprecision2none2020-MD 0.4 lower (0.56 to 0.24 lower)LOWIMPORTANT
1

Unclear ROB in 6 domains

2

MID = 0.5*SD in control group

3

95%CI crosses 2 MID boundaries (+/-0.1)

4

95%CI crosses one MID boundary (+/-0.15)

Appendix G. Economic evidence study selection

Economic evidence study selection for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

No evidence was identified which was applicable to this review question.

Figure 2. Study selection flow chart.

Figure 2Study selection flow chart

Appendix H. Economic evidence tables

Economic evidence tables for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

No evidence was identified which was applicable to this review question.

Appendix I. Economic evidence profiles

Economic evidence profiles for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

No evidence was identified which was applicable to this review question

Appendix J. Economic analysis

Economic evidence analysis for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

No economic analysis was conducted for this review question.

Appendix K. Excluded studies

Excluded studies for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

Clinical studies

Table 5Excluded studies and reasons for their exclusion

StudyReason for Exclusion
Abdel-Ghaffar, H. S., Moeen, S. M., Prophylactic Granisetron for post-spinal anesthesia shivering in Caesarean Section: a randomized controlled clinical study, Acta Anaesthesiologica Scandinavica, (no pagination), 2018 [PubMed: 29424008] Study from Egypt (developing country).
Adesiyan, A. O., Kushimo, O. T., Tobi, K. U., Intrathecal fentanyl does not increase bupivacaine-induced adverse thermoregulatory effects in women undergoing caesarean section under spinal anaesthesia, International journal of obstetric anesthesia. Conference: annual meeting of the obstetric anaesthetists’ association 2017. Belgium, 31, S20, 2017 Conference abstract.
Allen, T. K., Habib, A. S., Inadvertent Perioperative Hypothermia Induced by Spinal Anesthesia for Cesarean Delivery Might Be More Significant Than We Think: Are We Doing Enough to Warm Our Parturients?, Anesthesia and Analgesia, 126, 7–9, 2018 [PMC free article: PMC5748140] [PubMed: 29252474] Narrative opinion paper. No primary data.
Anaraki, A. N., Mirzaei, K., The Effect of Different Intrathecal Doses of Meperidine on Shivering during Delivery Under Spinal Anesthesia, International Journal of Preventive Medicine, 3, 706–12, 2012 [PMC free article: PMC3482998] [PubMed: 23112897] Study from Iran (developing country).
Atashkhoyi, S., Iranpour, A., Effect of tramadol on prevention of shivering after spinal anesthesia for cesarean section, BJOG, 115, 90, 2008 Conference abstract.
Atashkhoyi, S., Negargar, S., Effect of tramadol for prevention of shivering after spinal anesthesia for cesarean section, Journal of maternal-fetal & neonatal medicine, 21, 61, 2008 Conference abstract.
Azam, M., Asad, N., Butt, T. A., Ahmad, W., Efficacy of prophylactic intravenous ketamine vs tramadol for prevention of intraoperative shivering in spinal anesthesia for patient undergoing cesarean section, Pakistan journal of medical and health sciences, 12, 455–458, 2018 Study from Pakistan (developing country).
Badawy, A. A., Mokhtar, A. M., The role of ondansetron in prevention of post-spinal shivering (PSS) in obstetric patients: A double-blind randomized controlled trial, Egyptian journal of anaesthesia, 33, 29–33, 2017 Study from Egypt (developing country).
Bao, Z., Zhou, C., Wang, X., Zhu, Y., Intravenous dexmedetomidine during spinal anaesthesia for caesarean section: A meta-analysis of randomized trials, Journal of International Medical Research, 45, 924–932, 2017 [PMC free article: PMC5536398] [PubMed: 28553766] Systematic review: analyses cannot be used in entirety, included studies checked for inclusion (excluded as all were from developing/non-OECD countries).
Bernardis, R. C. G. D., Siaulys, M. M., Vieira, J. E., Mathias, L. A. S. T., Perioperative warming with a thermal gown prevents maternal temperature loss during elective cesarean section. A randomized clinical trial, Brazilian Journal of Anesthesiology, 66, 451–455, 2016 [PubMed: 27421966] Study from Brazil (developing country).
Butwick, A. J., Lipman, S. S., Andes, L., Cohen, S. E., Carvalho, B., Does forced air-warming reduce hypothermia and shivering for patients undergoing cesarean section with spinal anesthesia?, Anesthesiology, 102, 29, 2005 Conference abstract. Full text included.
Canturk, M., Canturk, F. K., Kocaoglu, N., Hakki, M., The effects of crystalloid warming on maternal body temperature and fetal outcomes: a randomized controlled trial, Brazilian Journal of Anesthesiology, 2018 [PMC free article: PMC9391735] [PubMed: 30448094] Non-English language article.
Capogna, G., Celleno, D., IV clonidine for post-extradural shivering in parturients: a preliminary study, British Journal of Anaesthesia, 71, 294–5, 1993 [PubMed: 8123410] Non-relevant intervention
Chakladar, A., Harper, C. M., Peri-operative warming in caesarean sections: guidance would be NICE, Anaesthesia, 65, 212–3, 2010 [PubMed: 20402853] Editorial/Commentary only
Chan, A. M., Ng, K. F., Tong, E. W., Jan, G. S., Control of shivering under regional anesthesia in obstetric patients with tramadol, Canadian Journal of Anaesthesia, 46, 253–8, 1999 [PubMed: 10210050] Non-relevant intervention
Chen, A. K., Kwan, W. F., Harrity, W. V., The effect of epidural butorphanol and fentanyl on shivering during cesarean section, Regional Anesthesia, 16, 30, 1991 Conference abstract
de Figueiredo Locks, G., Incidence of shivering after cesarean section under spinal anesthesia with or without intrathecal sufentanil: a randomized study, Revista Brasileira de Anestesiologia, 62, 676–84, 2012 [PubMed: 22999400] Study from Brazil (developing country)
El-Deeb, A., Barakat, R., Could ephedrine replace meperidine for prevention of shivering in women undergoing Cesarean Section under spinal anesthesia? A randomized study, Egyptian Journal of Anaesthesia, 28, 237–241, 2012 Study from Egypt (developing country)
Faiz, S. H. R., Rahimzadeh, P., Imani, F., Bakhtiari, A., Intrathecal injection of magnesium sulfate: shivering prevention during cesarean section: a randomized, double-blinded, controlled study, Korean Journal of Anesthesiology, 65, 293–298, 2013 [PMC free article: PMC3822019] [PubMed: 24228140] Study from Iran (developing country)
Feng, L. S., Hong, G., Yan, Z., Qiu, L. Y., Liang, L. A., Intrathecal sufentanil does not reduce shivering during neuraxial anesthesia: A meta-analysis, Medical Science Monitor, 22, 258–266, 2016 [PMC free article: PMC4732550] [PubMed: 26806131] Non-relevant intervention (Sufentanil not licensed in UK)
Gang, S., Zhengyuan, S., Chunnan, J., The effectiveness of active warming for women undergoing elective caesarean section on maternal shivering: A meta-analysis, Biomedical Research (India), 28, 8728–8730, 2017 Systematic review: analyses cannot be used in entirety, included studies checked for inclusion
Goyal, Parveen, Kundra, Sandeep, Sharma, Shruti, Grewal, Anju, Kaul, Tej, Singh, M, Efficacy of intravenous fluid warming for maintenance of core temperature during lower segment cesarean section under spinal anesthesia, Journal of Obstetric Anaesthesia and Critical Care, 1, 73–77, 2011 Study from developing/non-OECD country
Gulhas,N., Tekdemir,D., Durmus,M., Yucel,A., Erdil,F.A., Yologlu,S., Ersoy,M.O., The effects of ephedrine on maternal hypothermia in caesarean sections: a double blind randomized clinical trial, European Review for Medical and Pharmacological Sciences, 17, 2051–2058, 2013 [PubMed: 23884826] Study from developing country (Turkey). Specific sub-population of women who developed hypotension.
Han, J. W., Kang, H. S., Choi, S. K., Park, S. J., Park, H. J., Lim, T. H., Comparison of the Effects of Intrathecal Fentanyl and Meperidine on Shivering after Cesarean Delivery under Spinal Anesthesia, Korean Journal of Anesthesiology, 52, 657–662, 2007 Non-English language article.
He, L., Xu, J. M., Liu, S. M., Chen, Z. J., Li, X., Zhu, R., Intrathecal dexmedetomidine alleviates shivering during cesarean delivery under spinal anesthesia, Biological & pharmaceutical bulletin, 40, 169–173, 2017 [PubMed: 28154256] Study in developing/non-OECD country
Hernandez-Bernal, C. E., Martinez-Sanchez, A., Oriol-Lopez, S. A., Castelazo-Arredondo, J. A., Tremor and epidural blocking in caesarean, Revista mexicana de anestesiologia, 32, 107–113, 2009 Non-English language.
Honarmand, A., Safavi, M., Hirmanpour, A., Afzali, S., The effect of intravenous hydrocortisone (1 or 2 mg/kg) on postoperative shivering in cesarean section with spinal anesthesia, Journal of isfahan medical school, 35, 821–827, 2017 Study from developing country (Iran).
Hui,C.K., Huang,C.H., Lin,C.J., Lau,H.P., Chan,W.H., Yeh,H.M., A randomised double-blind controlled study evaluating the hypothermic effect of 150 microg morphine during spinal anaesthesia for Caesarean section, Anaesthesia, 61, 29–31, 2006 [PubMed: 16409339] Study from developing/non-OECD country
Jabalameli, M., Radmanesh, A., Comparing the efficacy of prophylactic intravenous dexamethasone and pethidine on postoperative shivering in elective cesarean section under spinal anaesthesia, Journal of isfahan medical school, 32, 678–689, 2014 Not English
Jabalameli, M., Sadeghi, A., Hirmanpour, A., Prevention of shivering during regional anesthesia in cesarean section: comparison of the two different doses of ketamine and placebo, Journal of isfahan medical school, 34, 1168–1173, 2016 Not English
Javaherforoosh, F., Akhondzadeh, R., Aein, K. B., Olapour, A., Samimi, M., Effects of tramadol on shivering post spinal anesthesia in elective cesarean section, Pakistan journal of medical sciences, 25, 12–17, 2009 Study from developing country (Iran).
Jeon, W. J., Kim, D. H., Choi, D. H., Patient Controlled Sedation Using Propofol during Regional Anesthesia for Cesarean Section, Korean Journal of Anesthesiology, 39, 534–541, 2000 Non-English language.
Ji, W., Wang, C., Lin, P., Effects of intrathecal morphine on shivering in parturients during cesarean section, Journal of clinical anesthesiology, 1, 20–21, 2000 Not English
Khan,Z.H., Zanjani,A.P., Makarem,J., Samadi,S., Antishivering effects of two different doses of intrathecal meperidine in caesarean section: a prospective randomised blinded study, European Journal of Anaesthesiology, 28, 202–206, 2011 [PubMed: 21325901] Study from developing country (Iran).
Khezri, M. B., Al-sadat Mosallaei, M., Ebtehaj, M., Mohammadi, N., Comparison of preemptive effect of intravenous ketorolac versus meperidine on postoperative shivering and pain in patients undergoing cesarean section under spinal anesthesia: a prospective, randomized, double-blind study, Caspian journal of internal medicine, 9, 151–157, 2018 [PMC free article: PMC5912223] [PubMed: 29732033] Study from developing country (Iran).
Khezri, M. B., Bandari, A. M., Asefzade, S., Atlasbaf, A., The effect of diclofenac na supp on postoperative shivering in patients undergoing elective cesarean section surgery, Pakistan journal of medical sciences, 27, 1145–1148, 2011 Study from developing country (Iran).
Kishore, N., Payaayaayal, Y. S., Kumar, N., Chauhan, N., In spinal anaesthesia for cesarean section the temperature of bupivacaine affects the onset of shivering but not the incidence: a randomized control trial, Journal of clinical and diagnostic research, 10, UC18–UC21, 2016 [PMC free article: PMC4740682] [PubMed: 26894154] Study from developing country (India).
Kose, E. A., Honca, M., Dal, D., Akinci, S. B., Aypar, U., Prophylactic ketamine to prevent shivering in parturients undergoing Cesarean delivery during spinal anesthesia, Journal of Clinical Anesthesia, 25, 275–80, 2013 [PubMed: 23664773] Study from developing country (Turkey).
Kwan, W. F., Chen, B. J., Wu, Y., Chuah, E. C., Epidural butorphanol but not nalbuphine ceases shivering in parturients during cesarean section, Anesthesia and Analgesia, 80, S259, 1995 Conference abstract.
Lamontagne, C., Lidzborski, E., Crochetiere, C., Villeneuve, E., Lesage, S., Intravenous dexmedetomidine for the treatment of shivering during cesarean delivery under neuraxial anesthesia, Canadian Journal of Anesthesia, 64, S5–S6, 2017 [PubMed: 30945105] Conference abstract
Lema, G. F., Gebremedhn, E. G., Gebregzi, A. H., Desta, Y. T., Kassa, A. A., Efficacy of intravenous tramadol and low-dose ketamine in the prevention of post-spinal anesthesia shivering following cesarean section: a double-blinded, randomized control trial, International Journal of Women’s Health, 9, 681–688, 2017 [PMC free article: PMC5628673] [PubMed: 29270031] Study from developing/non-OECD country
Li, Z., Tian, M., Zhang, C. Y., Li, A. Z., Huang, A. J., Shi, C. X., Xin, D. Q., Qi, J., Li, K. Z., A Randomised Controlled Trial to Evaluate the Effectiveness of Intrathecal Bupivacaine Combined with Different Adjuvants (Fentanyl, Clonidine and Dexmedetomidine) in Caesarean Section, Drug research, 65, 581–586, 2015 [PubMed: 25504002] Study from developing/non-OECD country
Liu, Jie, Wang, Yong, Ma, Wuhua, Shivering prevention and treatment during cesarean delivery under neuraxial anesthesia: a systematic review, Minerva Anestesiologica, 2018 [PubMed: 29945433] Systematic review: analyses cannot be used in entirety, included studies checked for inclusion
Liu, W. H., Luxton, M. C., The effect of prophylactic fentanyl on shivering in elective caesarean section under epidural analgesia, Anaesthesia, 46, 344–8, 1991 [PubMed: 2035777] Non-relevant intervention
McCarroll, S. M., Cartwright, P., Weeks, S. K., Donati, F., Warming intravenous fluids and the incidence of shivering during caesarean sections under epidural anaesthesia, Canadian anaesthetists’ society journal, 33, 72–73, 1986 Conference abstract
Moola, S., Lockwood, C., Effectiveness of strategies for the management and/or prevention of hypothermia within the adult perioperative environment, International Journal of Evidence-Based Healthcare, 9, 337–45, 2011 [PubMed: 22093385] Systematic review: analyses cannot be used in entirety, included studies checked for inclusion
Moola, Sandeep, Lockwood, Craig, The effectiveness of strategies for the management and/or prevention of hypothermia within the adult perioperative environment: systematic review, JBI library of systematic reviews, 8, 752–792, 2010 [PubMed: 27820534] Systematic review: analyses cannot be used in entirety, included studies checked for inclusion
Munday, J., Hines, S., Wallace, K., Chang, A. M., Gibbons, K., Yates, P., A systematic review of the effectiveness of warming interventions for women undergoing cesarean section, Worldviews on Evidence-Based Nursing, 11, 383–93, 2014 [PubMed: 25269994] Systematic review: analyses cannot be used in entirety, included studies checked for inclusion
Munday,J., Hines,S., Wallace,K., Chang,A.M., Gibbons,K., Yates,P., The clinical effectiveness of interventions to assist perioperative temperature management for women undergoing cesarean section: A systematic review, JBI Database of Systematic Reviews and Implementation Reports, 11, 45–111, 2013 [PubMed: 27820449] Duplicate article of systematic review.
Najafianaraki, A., Mirzaei, K., Akbari, Z., Macaire, P., The effects of warm and cold intrathecal bupivacaine on shivering during delivery under spinal anesthesia, Saudi journal of anaesthesia, 6, 336–40, 2012 [PMC free article: PMC3591550] [PubMed: 23493460] Study from developing country (Iran).
Nallam, Srinivasa Rao, Cherukuru, Kavya, Sateesh, Gokul, Efficacy of Intravenous Ondansetron for Prevention of Postspinal Shivering during Lower Segment Cesarean Section: A Double-Blinded Randomized Trial, Anesthesia, essays and researches, 11, 508–513, 2017 [PMC free article: PMC5490147] [PubMed: 28663651] Study from developing country (India).
Nasseri, K., Ghadami, N., Nouri, B., Effects of intrathecal dexmedetomidine on shivering after spinal anesthesia for cesarean section: a double-blind randomized clinical trial, Drug design, development & therapy, 11, 1107–1113, 2017 [PMC free article: PMC5388208] [PubMed: 28435222] Study from developing country (Iran).
Nasseri, K., Shami, S., Sarshivie, F., Intrathecal morphine decreases shivering during caesarean section under spinal anesthesia, Regional Anesthesia and Pain Medicine, Conference: 35th Annual European Society of Regional Anaesthesia and Pain Therapy Congress, ESRA 2016. Netherlands. Conference Start: 20160907. Conference End: 20160910. 41, e125, 2016 Conference abstract
Nct,, Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery, Https:​//clinicaltrials​.gov/show/nct02837913, 2016 Trial registration only. No data.
Nct,, A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section, Https:​//clinicaltrials​.gov/show/nct01054209, 2010 Trial registration only. No data.
Nct,, Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia, Https:​//clinicaltrials​.gov/show/nct03316716, 2017 Trial registration only. No data.
Nct,, Pre-warming Prevents Hypothermia in Elective Cesarean Section, Https:​//clinicaltrials​.gov/show/nct02091466, 2014 Trial registration only. No data.
Nct,, Shivering Treatment After Cesarean Delivery: meperidine vs. Dexmedetomidine, Https:​//clinicaltrials​.gov/show/nct03115047, 2017 Trial registration only. No data.
Nct,, Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia, Https:​//clinicaltrials​.gov/show/nct02384343, 2015 Trial registration only. No data.
Nct,, Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery, Https:​//clinicaltrials​.gov/show/nct03473470, 2018 Trial registration only. No data.
Onyekwulu, F. A., Agu, E. E., Amucheazi, A. O., Efficacy of intravenous tramadol in the control of shivering following spinal anaesthesia for caesarean section, Nigerian Postgraduate Medical Journal, 23, 116–20, 2016 [PubMed: 27623721] Study from developing country (Nigeria).
Oshvandi, Khodayar, Hasan Shiri, Fatemeh, Safari, Mahmoud, Fazel, Mohamad Reza, Salavati, Mohsen, Hassan Tehrani, Tayebeh, Effect of Pre-warmed Intravenous Fluid Therapy on Prevention of Postoperative Shivering after Caesarean Section, Hayat, 17, 5–15, 2012 Full text only available in Arabic
Oshvandi, Khodayar, Shiri, Fatemeh Hasan, Fazel, Mohammad Reza, Safari, Mahmoud, Ravari, Ali, The effect of pre-warmed intravenous fluids on prevention of intraoperative hypothermia in cesarean section, Iranian journal of nursing and midwifery research, 19, 64–9, 2014 [PMC free article: PMC3917187] [PubMed: 24554962] Study from developing country (Iran).
Parsa, T., Dabir, S., Radpay, B., Efficacy of pethidine and buprenorphine for prevention and treatment of postanesthetic shivering, Tanaffos, 6, 54–58, 2007 Study from developing country (Iran).
Patel, M. D., Balachander, H., Bhat, R. R., Krishanappa, S., Nagappa, M., Intravenous vs intrathecal fentanyl in prevention of intraoperative shivering, Journal of Anaesthesiology Clinical Pharmacology, 26, 11–14, 2010 Study from developing country (India).
Pazuki, S., Kamali, A., Shahrokhi, N., Jamilian, M., Comparison of the effects of intrathecal midazolam and tramadol with the conventional method of postoperative pain and shivering control after elective cesarean section, Biomedical and pharmacology journal, 9, 995–1003, 2016 Study from developing country (Iran).
Ponte, J., Collett, B. J., Walmsley, A., Anaesthetic temperature and shivering in epidural anaesthesia, Acta Anaesthesiologica Scandinavica, 30, 584–7, 1986 [PubMed: 3811803] Non-relevant intervention
Rastegarian, A., Ghobadifar, M. A., Kargar, H., Mosallanezhad, Z., Intrathecal meperidine plus lidocaine for prevention of shivering during cesarean section, The Korean journal of pain, 26, 379–86, 2013 [PMC free article: PMC3800711] [PubMed: 24156005] Study from developing country (Iran).
Reidy, J., Preston, R., Douglas, J., Sherlock, R., Tyler, J., The effect of maternal warming during cesarean delivery on neonatal temperature, UNPUBLISHED MANUSCRIPT, 2008 Unavailable (unpublished manuscript)
Roth, Jonathan V., Hypothermia During Cesarean Delivery, Anesthesia and Analgesia, 126, 2151–2152, 2018 [PubMed: 29533262] Letter to editor.
Roy, J. D., Girard, M., Drolet, P., Guay, J., Cesarean section: the effect of intrathecal meperidine on shivering, Canadian Journal of Anesthesia, 48, A4, 2001 Conference abstract.
Sachidananda, Roopa, Basavaraj, K., Shaikh, Safiya I., Umesh, G., Bhat, Triveni, Arpitha, B., Comparison of Prophylactic Intravenous Magnesium Sulfate with Tramadol for Postspinal Shivering in Elective Cesarean Section: A Placebo Controlled Randomized Double-blind Pilot Study, Anesthesia, essays and researches, 12, 130–134, 2018 [PMC free article: PMC5872849] [PubMed: 29628568] Study from developing country (India)
Sadegh, Ali, Tazeh-Kand, Nasrin Faridi, Eslami, Bita, Intrathecal fentanyl for prevention of shivering in spinal anesthesia in cesarean section, Medical journal of the Islamic Republic of Iran, 26, 85–9, 2012 [PMC free article: PMC3587896] [PubMed: 23483276] Study from developing country (Iran)
Shami, S., Nasseri, K., Shirmohammadi, M., Effect of low dose intrathechal meperidine on the incidence of shivering during cesarean section under spinal anesthesia; a randomized, placebo-controlled, double blind-clinical trial, Regional Anesthesia and Pain Medicine, Conference: 35th Annual European Society of Regional Anaesthesia and Pain Therapy Congress, ESRA 2016. Netherlands. Conference Start: 20160907. Conference End: 20160910. 41, e38, 2016 Conference abstract
Shami, S., Nasseri, K., Shirmohammadi, M., Sarshivi, F., Ghadami, N., Ghaderi, E., Pouladi, M., Barzanji, A., Effect of low dose of intrathecal pethidine on the incidence and intensity of shivering during cesarean section under spinal anesthesia: a randomized, placebo-controlled, double-blind clinical trial, Drug design, development & therapy, 10, 3005–3012, 2016 [PMC free article: PMC5036596] [PubMed: 27703328] Study from developing country (Iran)
Sharkey, A., Gulden, R. H., Lipton, J. M., Giesecke, A. H., Effect of radiant heat on the metabolic cost of postoperative shivering, British Journal of Anaesthesia, 70, 449–50, 1993 [PubMed: 8499207] Mixed population of women undergoing CS or tubal ligation.
Siedentopf, J. P., Does surrounding temperature influence the rate of hypothermia during Caesarean section?, British Journal of Anaesthesia, 119, 838, 2017 [PubMed: 29121313] Letter to the editor.
Sultan, P., Carvalho, B., Does the addition of active body warming to in-line intravenous fluid warming prevent maternal hypothermia during elective caesarean section? A randomised controlled trial, International Journal of Obstetric Anesthesia, 35, 115–116, 2018 [PubMed: 29343417] Letter to the editor
Sultan, P., Habib, A. S., Cho, Y., Carvalho, B., The Effect of patient warming during Caesarean delivery on maternal and neonatal outcomes: a meta-analysis, British Journal of Anaesthesia, 115, 500–10, 2015 [PMC free article: PMC4574493] [PubMed: 26385660] Systematic review: analyses cannot be used in entirety, included studies checked for inclusion
Sun, H. L., Ling, Q. D., Sun, W. Z., Wu, R. S. C., Wu, T. J., Wang, S. C., Chien, C. C., Lower limb wrapping prevents hypotension, but not hypothermia of shivering, after the introduction of epidural anesthesia for cesarean delivery, Anesthesia and Analgesia, 99, 241–244, 2004 [PubMed: 15281537] Study from developing/non-OECD country
Sun, Y., Xu, Y., Wang, G. N., Comparative Evaluation of Intrathecal Bupivacaine Alone, Bupivacaine-fentanyl, and Bupivacaine-dexmedetomidine in Caesarean Section, Drug research, 65, 468–472, 2015 [PubMed: 25207707] Study from developing/non-OECD country
Talakoub, R., Meshkati, ShN, Tramadol versus meperidine in the treatment of shivering during spinal anesthesia in cesarean section, Journal of research in medical sciences, 11, 151–155, 2006 Study from developing country (Turkey). Letter to the editor.
Techanivate, A., Rodanant, O., Tachawattanawisal, W., Somsiri, T., Intrathecal fentanyl for prevention of shivering in cesarean section, Journal of the Medical Association of Thailand, 88, 1214–21, 2005 [PubMed: 16536107] Study from developing country (Thailand).
Tsai, Y. C., Chu, K. S., A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients, Anesthesia & Analgesia, 93, 1288–92, 2001 [PubMed: 11682416] Study from developing/non-OECD country
Verma, A., Bhandari, D., Dhande, P., Jain, S., Tidke, S., Comparative evaluation of dexmedetomidine and tramadol for attenuation of post-spinal anaesthesia shivering, Journal of clinical and diagnostic research, 12, UC01–UC04, 2018 Study from developing country (India).
Woolnough, M. J., Newton, R. S., Walters, M., Chebbout, R., Active warming for elective caesarean section: a randomised controlled trial, International journal of obstetric anesthesia., 26, S10, 2016 Conference abstract
Xue, X., Lv, Y., Zhao, Y., Leng, Y., Zhang, Y., Efficacy of prophylactic epidural ketamine for reducing shivering in patients undergoing caesarean section with combined spinal-epidural anesthesia, Biomedical reports, 8, 485–490, 2018 [PMC free article: PMC5920941] [PubMed: 29732150] Study from developing/non-OECD country
Zabetian, H., Jahromi, A. S., Karami, M. Y., Ghobadifar, M. A., Antishivering effect of low dose meperidine in caesarean section under spinal anesthesia: A randomized double-blind placebo-controlled trial, International Journal of Pharmacology, 9, 305–11, 2013 Study from developing country (Iran).
Zhang, J., Zhang, X., Wang, H., Zhou, H., Tian, T., Wu, A., Dexmedetomidine as a neuraxial adjuvant for prevention of perioperative shivering: Meta-analysis of randomized controlled trials, PLoS ONE, 12, e0183154, 2017 [PMC free article: PMC5567500] [PubMed: 28829798] Systematic review. Five studies assessed C-section, all five assessed for inclusion
Economic studies

No economic evidence was identified for this review.

Appendix L. Research recommendations

Research recommendations for review question: What are the procedures to prevent and manage hypothermia and shivering in women having a caesarean birth in the pre-operative, peri-operative and post-operative periods?

No research recommendations were made for this review question.

Tables

Table 1Summary of the protocol (PICO table)

Population

For prevention of hypothermia/shivering: All women having a caesarean birth

For management of hypothermia/shivering: Women having a caesarean birth who are identified as having hypothermia and/or shivering

  • include any of the different modes of anaesthesia (general anaesthesia/epidural anaesthesia/spinal anaesthesia)
  • include any type of caesarean birth (emergency or planned)

Intervention
  • Active warming measures (a process that transfers heat to the patient)
    • forced air warming
    • electric blanket
    • radiant heater
    • warmed cotton blankets
    • fluid warming including
      -

      (IV) fluid warmers (including blood/blood products)

      -

      other methods of fluid warming

    • heating pad
  • Thermal insulation measures
    • leg wrapping
    • compression boots
    • room temperature
    • reflective (“space”) blankets
  • Pharmacological therapy
    • used to reduce heat redistribution (e.g. vasoconstrictors, such as phenylephrine, metaraminol, noradrenaline/norepinephrine)
    • other post-delivery drugs
    • pethidine
Comparison
  • Each of the interventions outlined above
  • Placebo
  • No treatment/usual care
OutcomesCritical outcomes:
  • Incidence of hypothermia
  • Shivering
  • Estimated blood loss
Important outcomes
  • Rate of change of temperature/ maternal temperature change (increase or decrease)
  • Maternal temperature at different time points
  • Thermal comfort
  • Wound infection

Table 2Summary of included studies

StudyPopulationComparisonOutcomesComments

Browning 2013

RCT

Australia

Scheduled for elective CB
  • n=118 ondansetron
  • n=60 control

Intervention (ondansetron 8mg)

versus

saline placebo

  • Shivering
  • Maternal temp at different time points
  • Prevention
  • Combined spinal-epidural

Butwick 2007

RCT

USA

Scheduled for CB
  • n=15 forced air-warming unit
  • n=15 control

Intervention (forced air warming – lower body, 43°C)

versus

placebo cover (warmer switched off)

  • Hypothermia (incidence)
  • Shivering
  • Estimated blood loss
  • Maternal temp at different time points
  • Maternal temp change
  • Thermal comfort
  • Prevention
  • Spinal or epidural

Casey 1988

RCT

Canada

  • n=46 studied overall (23 per group);
  • n=40 treated for shivering
(20 per group)

Intervention: intravenous meperidine 50 mg

versus

control IV 0.9% saline

  • Shivering at different time points
  • Maternal temp at different time points
  • Management
  • Epidural
  • Of the 46 observed, only 40 were analysed as they were treated for shivering.

Chakladar 2014

RCT

UK

Elective CB
  • n=59 mattress warming
  • n=60 control

Intervention (mattress warmer set at 40°C)

versus

placebo mattress (identical with warmer switched off)

  • Hypothermia (incidence)
  • Shivering
  • Estimated blood loss
  • Maternal temp at different time points
  • Prevention
  • Spinal or epidural

Chan 1989

RCT

Canada

Elective CB
  • n=21 warmed group
  • n=19 control group

Intervention: IV fluid warmer (36.5°C) + cleansers warmed (42°C) + extra gowns/socks/blankets

versus

control: unwarmed fluids, with single hospital gown

  • Shivering
  • Estimated blood loss
  • Maternal temp at different time points
  • Maternal temp change
  • Prevention
  • Epidural

Chebbout 2017

RCT

UK

Elective CB
  • n=44 standard care (IV fluid warming group)
  • n=44 forced air-warming
  • n=44 conduction mattress warming

Standard care (inc warmed IV fluids)

versus

Conduction mattress warming

versus

Forced air warming (38°C)

  • Hypothermia (incidence)
  • Estimated blood loss
  • Maternal temp at different time points
  • Thermal comfort
  • Wound infection
  • Prevention
  • Spinal
  • 3-arm trial;
  • All participants received warmed IV fluid, delivered through a fluid warmer set to 40°C

Chung 2012

RCT

South Korea

Elective CB
  • n=15 fluid warming
  • n=15 forced air-warming
  • n=15 standard care

Fluid warming (warming cabinet 40°C)

versus

Forced air warming (upper body at 43°C)

versus

Control (no additional warming/stan dard care)

  • Shivering
  • Estimated blood loss
  • Maternal temp at different time points
  • Maternal temp change
  • Thermal comfort
  • Prevention
  • Spinal
  • 3-arm trial

Cobb 2016

RCT

USA

Scheduled CB
  • n=23 warmed IV fluid and forced air-warming
  • n=23 no warming

Intervention: received IV fluid warmed to 41ºC through a fluid warmer + air-warming blanket (lower body)

versus

no warming (blanket provided but not switched on)

  • Shivering
  • Estimated blood loss
  • Maternal temp at different time points
  • Thermal comfort
  • Prevention
  • Spinal

Duryea 2016

Cluster RCT

USA

CB in high risk labour ward
  • n=419 lower ambient temp 20°C
  • n=406 higher ambient temp 23°C
Operating room temperature was set at either 20°C or 23°C
  • Hypothermia (incidence)
  • Wound infection
  • Prevention
  • Regional

Fallis 2006

RCT

Canada

Elective CB
  • n=32 forced air-warming group
  • n=30 standard care

Forced air warming (upper body) 43 C

versus

standard care (warmed cotton blankets)

  • Shivering
  • Maternal temp at different time points
  • Maternal temp change
  • Thermal comfort
  • Prevention
  • Spinal

Grant 2015

Cluster RCT

USA

Any CB
  • n=243 warming mattress
  • n=241 standard care

Warming mattress set to 37°C

versus

standard care (tinfoil hat + warmed blankets + warmed IV fluids

  • Hypothermia (incidence)
  • Maternal temp at different time points
  • Wound infection
  • Prevention
  • Unspecified (results state 3% had general anaesthetic)

Hong 2005

RCT

South Korea

Elective CB
  • n=30 control (B)
  • n=30 (BM0.1)
  • n=30 (BM0.2)
  • n=30 (BP)

Control (B) group: 8–10mg of 0.5% bupivacaine

versus

BM0.1: 0.1mg morphine

versus

BM0.2: 0.2mg morphine

versus

BP: 10mg pethidine

  • Shivering
  • Maternal temp at different time points
  • Prevention
  • Combined spinal-epidural
  • 4-arm trial;
  • All groups used 8–10mg of 0.5% bupivacaine

Horn 2014

RCT

Germany

Any CB
  • n=19 active forced-air warming
  • n=21 control

Forced air cover (upper body) 44°C

versus

control (warmed blanket from 40°C heating cabinet)

  • Hypothermia (incidence)
  • Shivering
  • Maternal temp at different time points
  • Thermal comfort
  • Prevention
  • Spinal

Horn 2002

RCT

USA

Any CB
  • n=15 forced-air heating
  • n=15 control

Forced air cover (upper body) “high”

versus

Control (single cotton blanket).

  • Shivering
  • Maternal temp at different time points
  • Thermal comfort
  • Prevention
  • Epidural

Jorgensen 2000

RCT

Denmark

Any CB
  • n= 60 warm saline
  • n= 60 control

Warm saline

versus

cold saline

  • Shivering
  • Prevention
  • Spinal

Munday 2018

RCT

Australia

Any CB
  • n=25 pre-warming
  • n=25 control

20mins forced air warming at 43°C

versus

control (no warming)

  • Shivering
  • Maternal temp at different time points
  • Maternal temp change
  • Thermal comfort
  • Prevention
  • Spinal or combined spinal-epidural

Paris 2014

RCT

USA

  • n=73 warmed IV fluids
  • n=77 warmed under body pad
  • n=76 control/usual care

Warmed IV fluids: IV fluids

warmed to 41ºC versus foam warming pad at 40.3 C

versus

control: standard hospital linens and no warming

  • Hypothermia (incidence)
  • Estimated blood loss
  • Maternal temp at different time points
  • Prevention
  • Spinal
  • 3-arm trial

Roy 2004

RCT

Canada

Non-emergency CB
  • n=40; 20 per group

Intervention: meperidine (0.2mg/kg)

versus

control/placebo: saline (0.2mg/kg)

  • Shivering
  • Prevention
  • Spinal
  • Both groups received hyperbaric bupivacaine (0.75%; 10.5 mg), morphine 0.15 mg

Smith 2000

RCT

USA

Scheduled CB
  • n=35 intervention (warmed fluids)
  • n=32 control (room temperature fluids)

Warmed fluids/hotline 42°C

versus

control: IV room temp fluids (20–22°C)

  • Hypothermia (incidence)
  • Shivering
  • Estimated blood loss
  • Maternal temp at different time points
  • Prevention
  • Regional (spinal or epidural)

Sutherland 1991

RCT

Australia

Any CB
  • n=47 pethidine
  • n=47 control

Intervention: pethidine 25mg

versus

control/placebo: saline solution

  • Shivering
  • Prevention
  • Epidural

Woolnough 2009

RCT

UK

Any CB
  • n=25 room temperature (control)
  • n=25 cabinet
  • n=25 hotline

Room temperature fluids

versus

cabinet: pre-warming cabinet at 45°C

versus

hotline: continuous IV warming at 42°C

  • Shivering
  • Thermal comfort
  • Prevention
  • Combined spinal-epidural
  • 3-arm trial

Workhoven 1986

RCT

USA

Any CB
  • n=22 warmed IV fluids
  • n=22 control/room temperature IV fluids

Intervention: Pre-warming cabinet at 30–34°C

versus

control: fluids at room temp 20–22°C

  • Shivering
  • Maternal temp at different time points
  • Prevention
  • Epidural

Yokoyama 2009

RCT

Japan

Any CB
  • n=15 warmed fluid group
  • n=15 control

Pre-warmed in cabinet (41°C) + infused through warmer coil

versus

Control: stored in room at 25°C

  • Estimated blood loss
  • Maternal temp at different time points
  • Prevention
  • Spinal

CB: caesarean birth; IV: intravenous; N: number of women; RCT: randomised controlled trial

Final

Evidence review

This evidence review was developed by the National Guideline Alliance which is a part of the Royal College of Obstetricians and Gynaecologists

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

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