Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001214729
Ethics application status
Approved
Date submitted
31/08/2022
Date registered
9/09/2022
Date last updated
9/09/2022
Date data sharing statement initially provided
9/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Body temperature and shivering during caesarean sections
Scientific title
Accurate measurement of core body temperature and shivering occurrence in emergency caesarean sections compared to elective caesarean sections
Secondary ID [1] 307884 0
None
Universal Trial Number (UTN)
Trial acronym
TEMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypothermia 327515 0
Hyperthermia 327516 0
Shivering 327517 0
Condition category
Condition code
Reproductive Health and Childbirth 324624 324624 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The core temperature will be recorded continuously throughout the caesarean section (CS) journey with a 3M™ Bair Hugger™ core Temperature Monitoring System (BHTMS). The BHTMS has a sensor that is attached to the forehead. BHTMS will be applied in the holding bay while waiting for CS for elective CS patients and either in the birthing suite or at the time of arrival in operating theatre for emergency CS patients.
The first temperature logged by the BHTMS will be recorded as the patient’s baseline temperature. Core temperature monitoring with BHTMS is continued in operating theatre during caesarean section and in recovery room.
The overall duration of monitoring will be approximately 6 hours from the time of applying BHTMS to leaving the recovery room.
Intervention code [1] 324344 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332441 0
Core temperature change from the baseline at the onset of shivering (shivering threshold delta: difference in core temperature between baseline and the onset of shivering) between elective vs emergency caesarean section.

Core temperature is monitored by BHTMS and recorded in a logger attached to BHTMS. Data of the core temperature will be extracted via USB of the logger after the case. The onset of shivering is recorded by a research member or anaesthetist on a data sheet.
Timepoint [1] 332441 0
The time of the shivering onset
Secondary outcome [1] 413511 0
1. Maximum change in core temperature from the baseline between elective vs emergency caesarean section.

Core temperature is monitored by BHTMS and recorded in a logger attached to BHTMS. Data of the core temperature will be extracted via USB of the logger after the case.
Timepoint [1] 413511 0
The time of lowest core temperature and highest core temperature during the caesarean section.
Secondary outcome [2] 413667 0
2. Maximum change in core temperature between those who shivered vs those who did not shiver, and elective vs emergency caesarean section.

Core temperature is monitored by BHTMS and recorded in a logger attached to BHTMS. Data of the core temperature will be extracted via USB of the logger after the case.
Timepoint [2] 413667 0
The time of the maximum difference (increase or decrease) of core temperature from that of base line.

Eligibility
Key inclusion criteria
• Elective caesarean section under subarachnoid block (spinal/combined spinal and epidural anaesthesia)
• Intrapartum emergency caesarean section under epidural anaesthesia
• Age 18 or above
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient refusal
• Inability to consent
• ASA 3 or over
• Morbidly obese (BMI 50 or over)
• Category 1 or “Code Blue” emergency caesarean section (due to an “urgent threat to the life of the woman or the fetus” as per RANZCOG)
• Antepartum haemorrhage requiring blood transfusion
• Active warming with air forced blanket and/or fluid warmer are planned to use from the beginning of the caesarean section

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Our primary endpoint is the core temperature change from the baseline at the onset of shivering (shivering threshold delta). The pilot data completed by C. Mullington (co-investigator) showed that the mean core temperature changes at onset of shivering from baseline were -0.62 °C (SD 0.12) in elective CS and -0.03 °C (SD 0.15) in emergency CS.
We powered our study to detect a true difference in mean shivering threshold delta between emergency caesarean group and elective caesarean group of 0.25 °C which is clinically significant. Further, we assumed a pooled standard deviation of 0.5 °C as the bigger population variance is expected with larger and more diverse sample. The study therefore requires a sample size of: 85 for each group (elective and emergency CS), a total sample size of 170 to achieve a power of 90% and a level of significance of 5% (two sided). We aim to recruit total 200 patients (100 for elective and 100 for emergency CS).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23063 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 38392 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 24990 0
United Kingdom
State/province [1] 24990 0
London

Funding & Sponsors
Funding source category [1] 312157 0
Hospital
Name [1] 312157 0
Fiona Stanley Hospital
Country [1] 312157 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Dr, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 313684 0
Hospital
Name [1] 313684 0
St Mary's Hospital
Address [1] 313684 0
Praed Street, London W2 1NY
Country [1] 313684 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311548 0
South Metropolitan Health Service
Ethics committee address [1] 311548 0
11 Robin Warren Dr, Murdoch WA 6150
Ethics committee country [1] 311548 0
Australia
Date submitted for ethics approval [1] 311548 0
Approval date [1] 311548 0
11/07/2022
Ethics approval number [1] 311548 0
RGS0000005199

Summary
Brief summary
Some women have a caesarean section (abbreviated as CS) to have a baby. The safest anaesthetic for this is with an injection in the mother’s back to make her numb from her breasts down which is called epidural or spinal anaesthesia. CS can be categorised as elective (planned) or emergency (unplanned). Elective CS takes place before the onset of labour (uterine contraction), whereas most emergency CS occurs after labour has started. Hypothermia (a low body temperature) is a common problem during elective CS and consequently active warming is recommended. By contrast, hyperthermia (a high body temperature) is a side effect of epidural pain relief during labour and therefore it is possible that hyperthermia is the dominant problem during emergency CS. The temperature changes during emergency CS are not fully understood. It is important to study temperature changes during CS because hypothermia and hyperthermia can cause problems for her or the baby. Some mothers shiver during CS which is an unpleasant side effect that makes it difficult for mothers to hold their babies and breastfeed shortly after birth. What we know so far is shivering during elective CS is caused by hypothermia and is effectively treated with active warming. During emergency CS, however, shivering occurs at normal or increased body temperatures and therefore active warming is likely inappropriate. At present, body temperature is not routinely checked during CS and therefore it is not possible to tailor temperature regulation strategies to individuals’ needs. In this multicentre cohort study, we will investigate how patterns of body temperature change differ between elective and emergency CSs, and how this relates to shivering.
We anticipate that this study will highlight the need to routinely measure body temperature during CS and will be a steppingstone towards personalised temperature management strategies during spinal and epidural anaesthesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121498 0
Dr Yayoi Ohashi
Address 121498 0
Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
Country 121498 0
Australia
Phone 121498 0
+61429047777
Fax 121498 0
Email 121498 0
Yayoi.Ohashi@health.wa.gov.au
Contact person for public queries
Name 121499 0
Dr Yayoi Ohashi
Address 121499 0
Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
Country 121499 0
Australia
Phone 121499 0
+61429047777
Fax 121499 0
Email 121499 0
Yayoi.Ohashi@health.wa.gov.au
Contact person for scientific queries
Name 121500 0
Dr Yayoi Ohashi
Address 121500 0
Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
Country 121500 0
Australia
Phone 121500 0
+61429047777
Fax 121500 0
Email 121500 0
Yayoi.Ohashi@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan to share the IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17075Study protocol    384610-(Uploaded-31-08-2022-16-04-45)-Study-related document.pdf
17076Informed consent form    384610-(Uploaded-06-09-2022-07-27-40)-Study-related document.pdf
17077Ethical approval    384610-(Uploaded-31-08-2022-16-06-17)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.