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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 control | Chan 1989; Chung 2012; Jorgensen 2000; Paris 2014; Smith 2000; Woolnough 2009; Workhoven 1986; Yokoyama 2009 |
2. FAW versus control | Butwick 2007; Chebbout 2017; Chung 2012; Fallis 2006; Horn 2002; Horn 2014; Munday 2018 |
3. FAW + warmed IV fluids versus control | Cobb 2016 |
4. Mattress warming versus control | Chakladar 2014; Chebbout 2017; Paris 2014 |
ACTIVE WARMING MEASURES versus OTHER ACTIVE WARMING | |
5. FAW versus warmed IV fluids | Chung 2012 |
6. FAW versus mattress warming | Chebbout 2017 |
7. Mattress warming versus other warming | Grant 2015; Paris 2014 |
THERMAL INSULATION MEASURES | |
8. Higher (23oC) versus lower (20oC) ambient temperature | Duryea 2016 |
PHARMACOLOGICAL THERAPY | |
9. 5-HT3 antagonist versus control | Browning 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:
- Nine studies focused on spinal anaesthesia only (Chebbout 2017, Chung 2012, Cobb 2016, Fallis 2006, Horn 2014, Jorgensen 2000, Paris 2014, Roy 2004, Yokoyama 2009).
- Five studies focused on epidural anaesthesia only (Casey 1988, Chan 1989, Horn 2002, Sutherland 1991, Workhoven 1986)
- Five studies focused on combined spinal-epidural anaesthesia (Browning 2013, Hong 2005, Woolnough 2009), or “regional” anaesthesia (Duryea 2016, Smith 2000)
- Four studies included more than one type of anaesthesia: any neuraxial spinal/epidural (Butwick 2007, Chakladar 2014) or spinal or combined (Munday 2018, unspecified: Grant 2015)
- No studies examined shivering and hypothermia in women having a caesarean birth with general anaesthesia, though 5 studies (Chakladar 2014, Chebbout 2017, Cobb 2016, Duryea 2016, Grant 2015) reported general anaesthetic use or conversion to general anaesthesia where spinal was insufficient or had failed. Conversion was rare (<5% of study participants in studies reporting conversion was necessary). A further 2 studies reported that conversion to general anaesthesia was unnecessary in all women (Butwick 2007, Woolnough 2009).
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, 2000Sutherland 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 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? |
Type of review question | Intervention |
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
Women undergoing caesarean birth who are identified as having hypothermia and/or shivering
|
Eligibility criteria – intervention(s)/exposure(s)/prognostic factor(s) |
|
Eligibility criteria – comparator(s)/control or reference (gold) standard |
|
Outcomes and prioritisation | Critical outcomes:
|
Eligibility criteria – study design | Only published full text papers
|
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-regression | Subgroup analyses (in case of heterogeneity):
|
Selection process – duplicate screening/selection/analysis | Duplicate 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 update | No – this is a new review question to be added to the guideline. |
Author contacts |
Developer: National Guideline Alliance |
Highlight if amendment to previous protocol | For details please see section 4.5 of Developing NICE guidelines: the manual |
Search strategy – for one database | For details please see appendix B |
Data collection process – forms/duplicate | A 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 collected | For 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:
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 |
Criteria for quantitative synthesis | For 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 bias | For details please see section 6.2 of Developing NICE guidelines: the manual. |
Confidence in cumulative evidence | For details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual |
Rationale/context – what is known | For 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/support | The NGA is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists |
Name of sponsor | The NGA is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists |
Roles of sponsor | NICE funds the NGA to develop guidelines for the NHS in England. |
PROSPERO registration number | Not 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 |
---|---|
1 | exp CESAREAN SECTION/ |
2 | (c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab. |
3 | or/1–2 |
4 | HYPOTHERMIA/ |
5 | hypothermia?.ti,ab. |
6 | SHIVERING/ |
7 | shiver$.ti,ab. |
8 | or/4–7 |
9 | 3 and 8 |
10 | limit 9 to english language |
11 | LETTER/ |
12 | EDITORIAL/ |
13 | NEWS/ |
14 | exp HISTORICAL ARTICLE/ |
15 | ANECDOTES AS TOPIC/ |
16 | COMMENT/ |
17 | CASE REPORT/ |
18 | (letter or comment*).ti. |
19 | or/11–18 |
20 | RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab. |
21 | 19 not 20 |
22 | ANIMALS/ not HUMANS/ |
23 | exp ANIMALS, LABORATORY/ |
24 | exp ANIMAL EXPERIMENTATION/ |
25 | exp MODELS, ANIMAL/ |
26 | exp RODENTIA/ |
27 | (rat or rats or mouse or mice).ti. |
28 | or/21–27 |
29 | 10 not 28 |
Databases: Embase; and Embase Classic
Date last searched: 22/11/2019
# | Searches |
---|---|
1 | exp CESAREAN SECTION/ |
2 | (c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab. |
3 | or/1–2 |
4 | HYPOTHERMIA/ |
5 | hypothermia?.ti,ab. |
6 | SHIVERING/ |
7 | shiver$.ti,ab. |
8 | or/4–7 |
9 | and 8 |
10 | limit 9 to english language |
11 | letter.pt. or LETTER/ |
12 | note.pt. |
13 | editorial.pt. |
14 | CASE REPORT/ or CASE STUDY/ |
15 | (letter or comment*).ti. |
16 | or/11–15 |
17 | RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab. |
18 | 16 not 17 |
19 | ANIMAL/ not HUMAN/ |
20 | NONHUMAN/ |
21 | exp ANIMAL EXPERIMENT/ |
22 | exp EXPERIMENTAL ANIMAL/ |
23 | ANIMAL MODEL/ |
24 | exp RODENT/ |
25 | (rat or rats or mouse or mice).ti. |
26 | or/18–25 |
27 | 10 not 26 |
Databases: Cochrane Central Register of Controlled Trials; and Cochrane Database of Systematic Reviews
Date last searched: 22/11/2019
# | Searches |
---|---|
#1 | MeSH 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 |
#4 | MeSH descriptor: [HYPOTHERMIA] this term only |
#5 | hypothermia*:ti,ab |
#6 | MeSH descriptor: [SHIVERING] this term only |
#7 | shiver*: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 |
---|---|
1 | ECONOMICS/ |
2 | VALUE OF LIFE/ |
3 | exp “COSTS AND COST ANALYSIS”/ |
4 | exp ECONOMICS, HOSPITAL/ |
5 | exp ECONOMICS, MEDICAL/ |
6 | exp RESOURCE ALLOCATION/ |
7 | ECONOMICS, NURSING/ |
8 | ECONOMICS, PHARMACEUTICAL/ |
9 | exp “FEES AND CHARGES”/ |
10 | exp BUDGETS/ |
11 | budget*.ti,ab. |
12 | cost*.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. |
17 | resourc* allocat*.ti,ab. |
18 | (fund or funds or funding* or funded).ti,ab. |
19 | (ration or rations or rationing* or rationed).ti,ab. |
20 | ec.fs. |
21 | or/1–20 |
22 | exp CESAREAN SECTION/ |
23 | (c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab. |
24 | or/22–23 |
25 | HYPOTHERMIA/ |
26 | hypothermia?.ti,ab. |
27 | SHIVERING/ |
28 | shiver$.ti,ab. |
29 | or/25–28 |
30 | 24 and 29 |
31 | limit 30 to english language |
32 | LETTER/ |
33 | EDITORIAL/ |
34 | NEWS/ |
35 | exp HISTORICAL ARTICLE/ |
36 | ANECDOTES AS TOPIC/ |
37 | COMMENT/ |
38 | CASE REPORT/ |
39 | (letter or comment*).ti. |
40 | or/32–39 |
41 | RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab. |
42 | 40 not 41 |
43 | ANIMALS/ not HUMANS/ |
44 | exp ANIMALS, LABORATORY/ |
45 | exp ANIMAL EXPERIMENTATION/ |
46 | exp MODELS, ANIMAL/ |
47 | exp RODENTIA/ |
48 | (rat or rats or mouse or mice).ti. |
49 | or/42–48 |
50 | 31 not 49 |
51 | 21 and 50 |
Databases: Embase; and Embase Classic
Date last searched: 22/11/2019
# | Searches |
---|---|
1 | HEALTH ECONOMICS/ |
2 | exp ECONOMIC EVALUATION/ |
3 | exp HEALTH CARE COST/ |
4 | exp FEE/ |
5 | BUDGET/ |
6 | FUNDING/ |
7 | RESOURCE ALLOCATION/ |
8 | budget*.ti,ab. |
9 | cost*.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. |
14 | resourc* allocat*.ti,ab. |
15 | (fund or funds or funding* or funded).ti,ab. |
16 | (ration or rations or rationing* or rationed).ti,ab. |
17 | or/1–16 |
18 | exp CESAREAN SECTION/ |
19 | (c?esar#an$ or c section$ or csection$ or (deliver$ adj3 abdom$)).ti,ab. |
20 | or/18–19 |
21 | HYPOTHERMIA/ |
22 | hypothermia?.ti,ab. |
23 | SHIVERING/ |
24 | shiver$.ti,ab. |
25 | or/21–24 |
26 | 20 and 25 |
27 | limit 26 to english language |
28 | letter.pt. or LETTER/ |
29 | note.pt. |
30 | editorial.pt. |
31 | CASE REPORT/ or CASE STUDY/ |
32 | (letter or comment*).ti. |
33 | or/28–32 |
34 | RANDOMIZED CONTROLLED TRIAL/ or random*.ti,ab. |
35 | 33 not 34 |
36 | ANIMAL/ not HUMAN/ |
37 | NONHUMAN/ |
38 | exp ANIMAL EXPERIMENT/ |
39 | exp EXPERIMENTAL ANIMAL/ |
40 | ANIMAL MODEL/ |
41 | exp RODENT/ |
42 | (rat or rats or mouse or mice).ti. |
43 | or/35–42 |
44 | 27 not 43 |
45 | 17 and 44 |
Database: Cochrane Central Register of Controlled Trials
Date last searched: 22/11/2019
# | Searches |
---|---|
#1 | MeSH descriptor: [ECONOMICS] this term only |
#2 | MeSH descriptor: [VALUE OF LIFE] this term only |
#3 | MeSH descriptor: [COSTS AND COST ANALYSIS] explode all trees |
#4 | MeSH descriptor: [ECONOMICS, HOSPITAL] explode all trees |
#5 | MeSH descriptor: [ECONOMICS, MEDICAL] explode all trees |
#6 | MeSH descriptor: [RESOURCE ALLOCATION] explode all trees |
#7 | MeSH descriptor: [ECONOMICS, NURSING] this term only |
#8 | MeSH descriptor: [ECONOMICS, PHARMACEUTICAL] this term only |
#9 | MeSH descriptor: [FEES AND CHARGES] explode all trees |
#10 | MeSH descriptor: [BUDGETS] explode all trees |
#11 | budget*:ti,ab |
#12 | cost*: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 |
#17 | resourc* 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 |
#21 | MeSH 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 |
#24 | MeSH descriptor: [HYPOTHERMIA] this term only |
#25 | hypothermia*:ti,ab |
#26 | MeSH descriptor: [SHIVERING] this term only |
#27 | shiver*:ti,ab |
#28 | #24 or #25 or #26 or #27 |
#29 | #23 and #28 |
#30 | #20 and #29 |
Appendix C. Clinical evidence study selection
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
Comparison 2. Forced air warming versus control
Comparison 4. Warmed mattress/under-body pad versus control
Active warming measures versus other active warming
Comparison 7. Warmed mattress/under-body pad vs other warming
Pharmacological therapy
Comparison 10. Opioid-like analgesic (pethidine) vs other opioid (morphine)
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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other consideratio ns | Warmed IV fluids | Control | Relative (95% CI) | Absolute | ||
Incidence of hypothermia (<36 C) - Maintained warming (37–42 C) | ||||||||||||
2 (Paris 2014; Smith 2000) | randomised trials | very serious1 | serious2 | no serious indirectness | very serious3 | none |
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 LOW | CRITICAL |
Incidence of shivering | ||||||||||||
6 (Chan 1989; Chung 2012; Jorgensen 2000; Smith 2000; Woolnough 2009; Workhoven 1986) | randomised trials | very serious4 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
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) | LOW | CRITICAL |
SUBGROUP: Incidence of shivering - Maintained warming (37–42 C) | ||||||||||||
3 (Jorgensen 2000; Smith 2000; Woolnough 2009) | randomised trials | very serious4 | no serious inconsistency | no serious indirectness | serious5 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of shivering - Pre-warmed only (37–42 C) | ||||||||||||
1 (Chung 2012) | randomised trials | very serious6 | no serious inconsistency | no serious indirectness | serious5 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of shivering - Pre-warmed only (30–34 C) | ||||||||||||
1 (Workhoven 1986) | randomised trials | very serious6,7 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
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) | LOW | CRITICAL |
SUBGROUP: Incidence of shivering - Maintained (36.5 C) plus blankets | ||||||||||||
1 (Chan 1989) | randomised trials | very serious6 | no serious inconsistency | no serious indirectness | very serious3 | none |
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 LOW | CRITICAL |
Estimated blood loss (Better indicated by lower values) | ||||||||||||
4 (Chan 1989; Chung 2012; Paris 2014; Yokoyama 2009) | randomised trials | very serious4 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 124 | 125 | - | MD 9.55 higher (35.11 lower to 54.22 higher) | LOW | CRITICAL |
SUBGROUP: Estimated blood loss - Maintained warming (37–42 C) (Better indicated by lower values) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious7 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 73 | 76 | - | MD 42.2 higher (15.24 lower to 99.64 higher) | LOW | CRITICAL |
SUBGROUP: Estimated blood loss - Pre-warmed only (37–42 C) (Better indicated by lower values) | ||||||||||||
2 (Chung 2012; Yokoyama 2009) | randomised trials | serious9 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 30 | 30 | - | MD 45.31 lower (131.67 lower to 41.04 higher) | MODERATE | CRITICAL |
SUBGROUP: Estimated blood loss - Maintained (36.5 C) plus blankets (Better indicated by lower values) | ||||||||||||
1 (Chan 1989) | randomised trials | very serious6 | no serious inconsistency | no serious indirectness | serious8,10 | none | 21 | 19 | - | MD 30 lower (154.85 lower to 94.85 higher) | VERY LOW | CRITICAL |
Estimated blood loss (need for blood products) | ||||||||||||
1 (Smith 2000) | randomised trials | very serious6 | no serious inconsistency | no serious indirectness | very serious11 | none |
0/35 (0%) |
0/32 (0%) | See comment12 | 0 more per 1000 (from 60 fewer to 60 more)16 | VERY LOW | CRITICAL |
Maternal (core) temperature change (Better indicated by higher values) | ||||||||||||
2 (Chan 1989; Chung 2012) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 36 | 34 | - | MD 0.4 higher (0.36 to 0.44 higher) | LOW | IMPORTANT |
Maternal temp (intraoperative) (Better indicated by higher values) | ||||||||||||
3 (Paris 2014; Smith 2000; Yokoyama 2009) | randomised trials | very serious5 | very serious14 | no serious indirectness | serious8,15 | none | 123 | 123 | - | MD 0.36 higher (0.09 to 0.64 higher) | VERY LOW | IMPORTANT |
Maternal temp (post-op, baseline) (Better indicated by higher values) | ||||||||||||
2 (Smith 2000; Yokoyama 2009) | randomised trials | no serious risk of bias | very serious16 | no serious indirectness | no serious imprecision8 | none | 50 | 47 | - | MD 0.61 higher (0.22 to 1 higher) | LOW | IMPORTANT |
Maternal temp (post-op, 30mins) (Better indicated by higher values) | ||||||||||||
2 (Smith 2000; Yokoyama 2009) | randomised trials | serious9 | very serious16 | no serious indirectness | no serious imprecision8 | none | 50 | 47 | - | MD 0.71 higher (0.32 to 1.1 higher) | VERY LOW | IMPORTANT |
Maternal temp (post-op, recovery room, 45mins+) (Better indicated by higher values) | ||||||||||||
3 (Paris 2014; Smith 2000; Yokoyama 2009) | randomised trials | very serious4 | very serious17 | no serious indirectness | serious8,18 | none | 123 | 123 | - | MD 0.51 higher (0.05 to 0.96 higher) | VERY LOW | IMPORTANT |
Maternal temp (post-op, discharge/postpartum) (Better indicated by higher values) | ||||||||||||
2 (Paris 2014; Smith 2000) | randomised trials | very serious1 | very serious19 | no serious indirectness | serious8,20 | none | 108 | 108 | - | MD 0.68 higher (0.16 to 1.2 higher) | VERY LOW | IMPORTANT |
Thermal comfort (Better indicated by higher values) | ||||||||||||
1 (Chung 2012) | randomised trials | very serious6 | no serious inconsistency | no serious indirectness | serious8,21 | none | 15 | 15 | - | MD 10 higher (0.11 lower to 20.11 higher) | VERY LOW | IMPORTANT |
Thermal comfort <4 | ||||||||||||
1 (Woolnough 2009) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | no serious imprecision | none |
4/50 (8%) |
8/25 (32%) | RR 0.25 (0.08 to 0.75) | 240 fewer per 1000 (from 80 fewer to 294 fewer) | HIGH | IMPORTANT |
Thermal comfort >6 | ||||||||||||
1 (Woolnough 2009) | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | very serious3 | none |
20/50 (40%) |
8/25 (32%) | RR 1.25 (0.64 to 2.43) | 80 more per 1000 (from 115 fewer to 458 more) | LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Forced air warming | Control | Relative (95% CI) | Absolute | ||
Incidence of hypothermia | ||||||||||||
3 (Butwick 2007; Chebbout 2017; Horn 2014) | randomised trials | very serious1 | very serious2 | no serious indirectness | very serious3 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of hypothermia – both groups had no additional warming (other than intervention) | ||||||||||||
2 (Butwick 2007; Horn 2014) | randomised trials | very serious1 | very serious2 | no serious indirectness | very serious3 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of hypothermia – both control and intervention groups also had maintained warmed IV fluids (41 C) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious4 | none |
0/43 (0%) |
0/44 (0%) | Not estimable5 | 0 more per 1000 (from 40 fewer to 40 more)6 | VERY LOW | CRITICAL |
Incidence of shivering | ||||||||||||
6 (Butwick 2007; Chung 2012; Fallis 2006; Horn 2002; Horn 2014; Munday 2018) | randomised trials | very serious7 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
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) | LOW | CRITICAL |
Estimated blood loss (Better indicated by lower values) | ||||||||||||
3 (Butwick 2007; Chung 2012; Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 73 | 74 | - | MD 11.23 higher (42.26 lower to 64.71 higher) | LOW | CRITICAL |
SUBGROUP: Estimated blood loss – no additional warming (Better indicated by lower values) | ||||||||||||
2 (Butwick 2007; Chung 2012) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious8,9 | none | 30 | 30 | - | MD 41.8 higher (28.78 lower to 112.38 higher) | VERY LOW | CRITICAL |
SUBGROUP: Estimated blood loss – both groups also with maintained warmed IV fluids (41 C) (Better indicated by lower values) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious8,10 | none | 43 | 44 | - | MD 30 lower (111.96 lower to 51.96 higher) | VERY LOW | CRITICAL |
Maternal temperature change (peri-op change) (Better indicated by lower values) | ||||||||||||
1 (Butwick 2007) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious8,11 | none | 15 | 15 | - | MD 0 higher (0.25 lower to 0.25 higher) | VERY LOW | IMPORTANT |
Maternal temperature change (intra-op change) (Better indicated by lower values) | ||||||||||||
3 (Chung 2012; Fallis 2006; Munday 2018) | randomised trials | very serious7 | very serious12 | no serious indirectness | serious8,13 | none | 72 | 70 | - | MD 0.06 higher (0.21 lower to 0.33 higher) | VERY LOW | IMPORTANT |
Maternal temperature (intra-op, within 30mins) (Better indicated by higher values) | ||||||||||||
2 (Chebbout 2017; Horn 2014) | randomised trials | very serious1 | very serious12 | no serious indirectness | serious8,14 | none | 62 | 65 | - | MD 0.11 lower (0.4 lower to 0.17 higher) | VERY LOW | IMPORTANT |
Maternal temperature (intra-op, immediately post-delivery) (Better indicated by higher values) | ||||||||||||
1 (Horn 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious8,15 | none | 19 | 21 | - | MD 0.1 lower (0.38 lower to 0.18 higher) | VERY LOW | IMPORTANT |
Maternal temperature (intra-op, end of surgery) (Better indicated by higher values) | ||||||||||||
4 (Chebbout 2017; Fallis 2006; Horn 2002; Horn 2014) | randomised trials | very serious1 | very serious16 | no serious indirectness | serious8,17 | none | 109 | 110 | - | MD 0.4 higher (0.01 to 0.8 higher) | VERY LOW | IMPORTANT |
Maternal temperature (post-op, recovery room, 15mins) (Better indicated by higher values) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious8,18 | none | 43 | 44 | - | MD 0.1 higher (0.02 to 0.18 higher) | VERY LOW | IMPORTANT |
Thermal comfort (pre-op) (Better indicated by higher values) | ||||||||||||
2 (Horn 2002; Horn 2014) | randomised trials | very serious1 | serious19 | no serious indirectness | serious8,20 | none | 34 | 36 | - | MD 6.46 higher (2.2 to 10.73 higher) | VERY LOW | IMPORTANT |
Thermal comfort (intra-op, immediately post-delivery) (Better indicated by higher values) | ||||||||||||
1 (Horn 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious8,21 | none | 19 | 21 | - | MD 8 higher (1.37 to 14.63 higher) | VERY LOW | IMPORTANT |
Thermal comfort (intra-op, end of surgery) (Better indicated by higher values) | ||||||||||||
1 (Horn 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 19 | 21 | - | MD 16 higher (9.79 to 22.21 higher) | LOW | IMPORTANT |
Thermal comfort (post-op) (Better indicated by higher values)L | ||||||||||||
3 (Butwick 2007; Chung 2012; Munday 2018) | randomised trials | very serious7 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 55 | 55 | - | MD 0.23 higher (0.17 lower to 0.63 higher) | LOW | IMPORTANT |
SUBGROUP: Thermal comfort (post-op) - post-op, recovery room, discharge (Better indicated by higher values) | ||||||||||||
2 (Butwick 2007; Chung 2012) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious8,22 | none | 30 | 30 | - | MD 3.28 higher (0.98 lower to 7.54 higher) | VERY LOW | IMPORTANT |
SUBGROUP: Thermal comfort (post-op) - peri-operative (Better indicated by higher values) | ||||||||||||
1 (Munday 2018) | randomised trials | very serious23 | no serious inconsistency | no serious indirectness | serious8,24 | none | 25 | 25 | - | MD 0.2 higher (0.2 lower to 0.6 higher) | VERY LOW | IMPORTANT |
Wound infection | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious3 | none |
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 LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | FAW + warmed IV fluid | Control | Relative (95% CI) | Absolute | ||
Incidence of hypothermia (peri-op) | ||||||||||||
1 (Cobb 2016) | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none |
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) | MODERATE | CRITICAL |
Incidence of shivering (intra-op) | ||||||||||||
1 (Cobb 2016) | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none |
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) | MODERATE | CRITICAL |
Incidence of shivering (post-op) | ||||||||||||
1 (Cobb 2016) | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | very serious3 | none |
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) | LOW | CRITICAL |
Estimated blood loss4 (Better indicated by lower values) | ||||||||||||
1 (Cobb 2016) | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | very serious5 | none |
22 median [IQR] 950 [800–1000] mL |
22 median [IQR] 975 [800–1000] mL | -4 | median diff 25 lower4 | LOW | CRITICAL |
Maternal temperature (intra-op, recovery room, baseline) (Better indicated by higher values) | ||||||||||||
1 (Cobb 2016) | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious6,7 | none | 22 | 22 | - | MD 0.4 higher (0.1 to 0.7 higher) | MODERATE | IMPORTANT |
Thermal comfort (post-op, recovery room, discharge)4 (Better indicated by higher values) | ||||||||||||
1 (Cobb 2016) | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | very serious5 | none |
22 median [IQR] 100 [95–100] |
22 median [IQR] 90 [70–100] | -4 | median difference 10 higher4 | LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Warmed mattress/under-body pad | Control | Relative (95% CI) | Absolute | ||
Incidence of hypothermia | ||||||||||||
3 (Chakladar 2014; Chebbout 2017; Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of hypothermia - undefined time point | ||||||||||||
2 (Chakladar 2014; Chebbout 2017) | randomised trials | serious3 | no serious inconsistency | no serious indirectness | serious2 | none |
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) | LOW | CRITICAL |
SUBGROUP: Incidence of hypothermia – postpartum | ||||||||||||
1 (Paris 2014) | randomised trials | very serious4 | no serious inconsistency | no serious indirectness | very serious5 | none |
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 LOW | CRITICAL |
Incidence of shivering | ||||||||||||
1 (Chakladar 2014) | randomised trials | serious6 | no serious inconsistency | no serious indirectness | very serious5 | none |
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 LOW | CRITICAL |
Estimated blood loss (Better indicated by lower values) | ||||||||||||
2 (Chebbout 2017; Paris 2014) | randomised trials | very serious7 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 121 | 120 | - | MD 0.41 lower (56.12 lower to 55.3 higher) | LOW | CRITICAL |
Maternal temperature (intra-op) (Better indicated by higher values) | ||||||||||||
3 (Chakladar 2014; Chebbout 2017; Paris 2014) | randomised trials | very serious1 | serious9 | no serious indirectness | no serious imprecision8 | none | 179 | 178 | - | MD 0.06 higher (0.01 to 0.12 higher) | VERY LOW | IMPORTANT |
SUBGROUP: Maternal temperature (intra-op) - start/first 30mins (Better indicated by higher values) | ||||||||||||
2 (Chakladar 2014; Chebbout 2017) | randomised trials | serious3 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 102 | 102 | - | MD 0.03 higher (0.04 lower to 0.1 higher) | MODERATE | IMPORTANT |
SUBGROUP: Maternal temperature (intra-op) - anytime in operating room (Better indicated by higher values) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious4 | no serious inconsistency | no serious indirectness | serious8,10 | none | 77 | 76 | - | MD 0.12 higher (0.03 to 0.21 higher) | VERY LOW | IMPORTANT |
Maternal temperature (intra-op, recovery room, baseline) (Better indicated by higher values) | ||||||||||||
2 (Chakladar 2014; Chebbout 2017) | randomised trials | serious3 | very serious11 | no serious indirectness | serious8,12 | none | 102 | 102 | - | MD 0.09 higher (0.11 lower to 0.28 higher) | VERY LOW | IMPORTANT |
Maternal temperature (post-op, recovery room) (Better indicated by higher values) | ||||||||||||
2 (Chebbout 2017; Paris 2014) | randomised trials | very serious7 | very serious13 | no serious indirectness | serious8,14 | none | 121 | 120 | - | MD 0.16 higher (0.16 lower to 0.48 higher) | VERY LOW | IMPORTANT |
Maternal temperature (post-op, postpartum) (Better indicated by higher values) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious4 | no serious inconsistency | no serious indirectness | no serious imprecision8 | none | 77 | 76 | - | MD 0.98 higher (0.81 to 1.15 higher) | LOW | IMPORTANT |
Wound infection | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious15 | no serious inconsistency | no serious indirectness | very serious5 | none |
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 LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Forced air warming | Warmed IV fluids | Relative (95% CI) | Absolute | ||
Incidence of shivering | ||||||||||||
1 (Chung 2012) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2 | none |
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 LOW | CRITICAL |
Estimated blood loss (Better indicated by lower values) | ||||||||||||
1 (Chung 2012) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious3,4 | none | 15 | 15 | - | MD 80 higher (20.2 lower to 180.2 higher) | VERY LOW | CRITICAL |
Maternal temperature change (intra-op, 45 minutes after intervention) (Better indicated by higher values) | ||||||||||||
1 (Chung 2012) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious3,5 | none | 15 | 15 | - | MD 0.1 lower (0.35 lower to 0.15 higher) | VERY LOW | IMPORTANT |
Thermal comfort (Better indicated by higher values) | ||||||||||||
1 (Chung 2012) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious3,6 | none | 15 | 15 | - | MD 0.3 lower (9.36 lower to 8.76 higher) | VERY LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Forced air warming | Mattress warming | Relative (95% CI) | Absolute | ||
Incidence of hypothermia (<36 C) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2 | none |
0/43 (0%) |
0/44 (0%) | See comment3 | 0 more per 1000 (from 40 fewer to 40 more)4 | VERY LOW | CRITICAL |
Estimated blood loss (Better indicated by lower values) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision5 | none | 43 | 44 | - | MD 20 lower (110.85 lower to 70.85 higher) | LOW | CRITICAL |
Maternal temperature (pre-op, 15 minutes after anaesthetic) (Better indicated by higher values) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision5 | none | 43 | 44 | - | MD 0 higher (0.08 lower to 0.08 higher) | LOW | IMPORTANT |
Maternal temperature (intra-op, recovery room, baseline) (Better indicated by higher values) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision5 | none | 43 | 44 | - | MD 0 higher (0.08 lower to 0.08 higher) | LOW | IMPORTANT |
Maternal temperature (post-op, recovery room, 15 min) (Better indicated by higher values) | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious5,6 | none | 43 | 44 | - | MD 0.1 higher (0.02 to 0.18 higher) | VERY LOW | IMPORTANT |
Wound infection | ||||||||||||
1 (Chebbout 2017) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious7 | none |
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 LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Warmed mattress/under body pad | Other warming | Relative (95% CI) | Absolute | ||
Incidence of hypothermia | ||||||||||||
2 (Grant 2015; Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2,3 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of hypothermia - Warmed IV fluids, tinfoil hats, warmed blankets | ||||||||||||
1 (Grant 2015) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2,3 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of hypothermia - Warmed IV fluids (maintained) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious4 | none |
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 LOW | CRITICAL |
Estimated blood loss - Warmed IV fluids (maintained) (Better indicated by lower values) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious5,6 | none | 77 | 73 | - | MD 37.11 lower (101.5 lower to 27.28 higher) | VERY LOW | CRITICAL |
Maternal temperature (intra-op) (Better indicated by higher values) | ||||||||||||
2 (Grant 2015; Paris 2014) | randomised trials | very serious1 | very serious7 | no serious indirectness | very serious2,5,8 | none | 208 | 204 | - | MD 0.08 higher (0.14 lower to 0.31 higher) | VERY LOW | IMPORTANT |
SUBGROUP: Maternal temperature (intra-op) - Warmed IV fluids, tinfoil hats, warmed blankets (Better indicated by higher values) | ||||||||||||
1 (Grant 2015) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2,5,9 | none | 131 | 131 | - | MD 0.2 higher (0.08 to 0.32 higher) | VERY LOW | IMPORTANT |
SUBGROUP: Maternal temperature (intra-op) - Warmed IV fluids (maintained) (Better indicated by higher values) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision5 | none | 77 | 73 | - | MD 0.03 lower (0.12 lower to 0.06 higher) | LOW | IMPORTANT |
Maternal temperature (post-op, recovery room) (Better indicated by higher values) | ||||||||||||
2 (Grant 2015; Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2,5 | none | 320 | 314 | - | MD 0.05 higher (0.03 lower to 0.13 higher) | VERY LOW | IMPORTANT |
SUBGROUP: Maternal temperature (post-op, recovery room) - Warmed IV fluids, tinfoil hats, warmed blankets (Better indicated by higher values) | ||||||||||||
1 (Grant 2015) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2,5 | none | 243 | 241 | - | MD 0 higher (0.11 lower to 0.11 higher) | VERY LOW | IMPORTANT |
SUBGROUP: Maternal temperature (post-op, recovery room) - Warmed IV fluids (maintained) (Better indicated by higher values) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious5,10 | none | 77 | 73 | - | MD 0.11 higher (0.01 lower to 0.23 higher) | VERY LOW | IMPORTANT |
Maternal temperature (post-op, postpartum) - Warmed IV fluids (maintained) (Better indicated by higher values) | ||||||||||||
1 (Paris 2014) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision5 | none | 77 | 73 | - | MD 0.05 higher (0.1 lower to 0.2 higher) | LOW | IMPORTANT |
Wound infection - Warmed IV fluids, tinfoil hats, warmed blankets | ||||||||||||
1 (Grant 2015) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2,4 | none |
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 LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Higher ambient temperature | Lower ambient temperature | Relative (95% CI) | Absolute | ||
Incidence of hypothermia <36 C | ||||||||||||
1 (Duryea 2016) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2,3 | none |
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 LOW | CRITICAL |
Wound infection | ||||||||||||
1 (Duryea 2016) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2,4 | none |
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 LOW | IMPORTANT |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | 5-HT3 antagonist | Control | Relative (95% CI) | Absolute | ||
Incidence of shivering | ||||||||||||
1 (Browning 2013) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | very serious2 | none |
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 LOW | CRITICAL |
Incidence of shivering (reached score 2–4) | ||||||||||||
1 (Browning 2013) | randomised trials | serious1 | no serious inconsistency | no serious indirectness | very serious2 | none |
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 LOW | CRITICAL |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Opioid-like analgesic (pethidine) | Other opioid (morphine) | Relative (95% CI) | Absolute | ||
Incidence of shivering | ||||||||||||
1 (Hong 2005) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of shivering - peth (10mg) vs morphine (0.1mg) | ||||||||||||
1 (Hong 2005) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious3 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of shivering - peth (10mg) vs morphine (0.2mg) | ||||||||||||
1 (Hong 2005) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious3 | none |
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 LOW | CRITICAL |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Opioid-like analgesic | Control | Relative (95% CI) | Absolute | ||
Incidence of shivering | ||||||||||||
3 (Hong 2005; Roy 2004; Sutherland 1991) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
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) | LOW | CRITICAL |
SUBGROUP: Incidence of shivering - pethidine (25mg) | ||||||||||||
1 (Sutherland 1991) | randomised trials | very serious2 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
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) | LOW | CRITICAL |
SUBGROUP: Incidence of shivering - pethidine (10mg) | ||||||||||||
1 (Hong 2005) | randomised trials | very serious2 | no serious inconsistency | no serious indirectness | serious3 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of shivering - meperidine (0.2mg/kg) | ||||||||||||
1 (Roy 2004) | randomised trials | serious4 | no serious inconsistency | no serious indirectness | serious3 | none |
9/20 (45%) |
17/20 (85%) | RR 0.53 (0.32 to 0.89) | 400 fewer per 1000 (from 94 fewer to 578 fewer) | LOW | CRITICAL |
SUBGROUP: Incidence of shivering - morphine (0.1mg) | ||||||||||||
1 (Hong 2005) | randomised trials | very serious2 | no serious inconsistency | no serious indirectness | very serious5 | none |
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 LOW | CRITICAL |
SUBGROUP: Incidence of shivering - morphine (0.2mg) | ||||||||||||
1 (Hong 2005) | randomised trials | very serious2 | no serious inconsistency | no serious indirectness | very serious5 | none |
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 LOW | CRITICAL |
- 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 assessment | No of patients | Effect | Quality | Importance | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Opioid-like analgesic (Meperidine) | Control | Relative (95% CI) | Absolute | ||
Incidence of shivering (2 mins post infusion) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
8/20 (40%) |
19/20 (95%) | RR 0.42 (0.24 to 0.73) | 551 fewer per 1000 (from 256 fewer to 722 fewer) | LOW | CRITICAL |
Incidence of shivering (5 mins post infusion) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
5/20 (25%) |
15/20 (75%) | RR 0.33 (0.15 to 0.74) | 502 fewer per 1000 (from 195 fewer to 637 fewer) | LOW | CRITICAL |
Incidence of shivering (15mins post) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
3/20 (15%) |
17/20 (85%) |
RR 0.18 (0.06 to 0.51) | 697 fewer per 1000 (from 417 fewer to 799 fewer) | LOW | CRITICAL |
Incidence of shivering (30 mins post) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
6/20 (30%) |
18/20 (90%) | RR 0.33 (0.17 to 0.66) | 603 fewer per 1000 (from 306 fewer to 747 fewer) | LOW | CRITICAL |
Incidence of shivering (60 mins post) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision | none |
5/20 (25%) |
14/20 (70%) | RR 0.36 (0.16 to 0.8) | 448 fewer per 1000 (from 140 fewer to 588 fewer) | LOW | CRITICAL |
Maternal core temp (2mins post) (Better indicated by higher values) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | very serious2,3 | none | 20 | 20 | - | MD 0 higher (0.12 lower to 0.12 higher) | VERY LOW | IMPORTANT |
Maternal core temp (5mins post) (Better indicated by higher values) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | serious2,4 | none | 20 | 20 | - | MD 0.1 lower (0.26 lower to 0.06 higher) | VERY LOW | IMPORTANT |
Maternal core temp (15mins post) (Better indicated by higher values) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | 20 | - | MD 0.3 lower (0.42 to 0.18 lower) | LOW | IMPORTANT |
Maternal core temp (30mins post) (Better indicated by higher values) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | 20 | - | MD 0.5 lower (0.62 to 0.38 lower) | LOW | IMPORTANT |
Maternal core temp (60mins post) (Better indicated by higher values) | ||||||||||||
1 (Casey 1988) | randomised trials | very serious1 | no serious inconsistency | no serious indirectness | no serious imprecision2 | none | 20 | 20 | - | MD 0.4 lower (0.56 to 0.24 lower) | LOW | IMPORTANT |
- 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.
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
Study | Reason 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: | 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: | Trial registration only. No data. |
Nct,, Active Warming Versus Non Active Warming During Caesarean Section for Preventing Neonatal Hypothermia, Https: | Trial registration only. No data. |
Nct,, Pre-warming Prevents Hypothermia in Elective Cesarean Section, Https: | Trial registration only. No data. |
Nct,, Shivering Treatment After Cesarean Delivery: meperidine vs. Dexmedetomidine, Https: | Trial registration only. No data. |
Nct,, Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia, Https: | Trial registration only. No data. |
Nct,, Evaluation of the Active Warming Effects on Maternal and Neonatal Outcome During Cesarean Delivery, Https: | 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
|
---|---|
Intervention |
|
Comparison |
|
Outcomes | Critical outcomes:
|
Table 2Summary of included studies
Study | Population | Comparison | Outcomes | Comments |
---|---|---|---|---|
RCT Australia | Scheduled for elective CB
|
Intervention (ondansetron 8mg) versus saline placebo |
|
|
RCT USA | Scheduled for CB
|
Intervention (forced air warming – lower body, 43°C) versus placebo cover (warmer switched off) |
|
|
RCT Canada |
|
Intervention: intravenous meperidine 50 mg versus control IV 0.9% saline |
|
|
RCT UK | Elective CB
|
Intervention (mattress warmer set at 40°C) versus placebo mattress (identical with warmer switched off) |
|
|
RCT Canada | Elective CB
|
Intervention: IV fluid warmer (36.5°C) + cleansers warmed (42°C) + extra gowns/socks/blankets versus control: unwarmed fluids, with single hospital gown |
|
|
RCT UK | Elective CB
|
Standard care (inc warmed IV fluids) versus Conduction mattress warming versus Forced air warming (38°C) |
|
|
RCT South Korea | Elective CB
|
Fluid warming (warming cabinet 40°C) versus Forced air warming (upper body at 43°C) versus Control (no additional warming/stan dard care) |
|
|
RCT USA | Scheduled CB
|
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) |
|
|
Cluster RCT USA | CB in high risk labour ward
| Operating room temperature was set at either 20°C or 23°C |
|
|
RCT Canada | Elective CB
|
Forced air warming (upper body) 43 C versus standard care (warmed cotton blankets) |
|
|
Cluster RCT USA | Any CB
|
Warming mattress set to 37°C versus standard care (tinfoil hat + warmed blankets + warmed IV fluids |
|
|
RCT South Korea | Elective CB
|
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 |
|
|
RCT Germany | Any CB
|
Forced air cover (upper body) 44°C versus control (warmed blanket from 40°C heating cabinet) |
|
|
RCT USA | Any CB
|
Forced air cover (upper body) “high” versus Control (single cotton blanket). |
|
|
RCT Denmark | Any CB
|
Warm saline versus cold saline |
|
|
RCT Australia | Any CB
|
20mins forced air warming at 43°C versus control (no warming) |
|
|
RCT USA |
|
Warmed IV fluids: IV fluids warmed to 41ºC versus foam warming pad at 40.3 C versus control: standard hospital linens and no warming |
|
|
RCT Canada | Non-emergency CB
|
Intervention: meperidine (0.2mg/kg) versus control/placebo: saline (0.2mg/kg) |
|
|
RCT USA | Scheduled CB
|
Warmed fluids/hotline 42°C versus control: IV room temp fluids (20–22°C) |
|
|
RCT Australia | Any CB
|
Intervention: pethidine 25mg versus control/placebo: saline solution |
|
|
RCT UK | Any CB
|
Room temperature fluids versus cabinet: pre-warming cabinet at 45°C versus hotline: continuous IV warming at 42°C |
|
|
RCT USA | Any CB
|
Intervention: Pre-warming cabinet at 30–34°C versus control: fluids at room temp 20–22°C |
|
|
RCT Japan | Any CB
|
Pre-warmed in cabinet (41°C) + infused through warmer coil versus Control: stored in room at 25°C |
|
|
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.