ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

TEMS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypothermia

Hyperthermia

Shivering

Condition category

Condition code

Reproductive Health and Childbirth

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

The time of the shivering onset

Secondary outcome [1]

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]

The time of lowest core temperature and highest core temperature during the caesarean section.

Secondary outcome [2]

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]

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?

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)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

London

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Fiona Stanley Hospital

Address [1]

11 Robin Warren Dr, Murdoch WA 6150

Country [1]

Australia

Primary sponsor type

Hospital

Name

Fiona Stanley Hospital

Address

11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

St Mary's Hospital

Address [1]

Praed Street, London W2 1NY

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service

Ethics committee address [1]

11 Robin Warren Dr, Murdoch WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/07/2022

Ethics approval number [1]

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

Dr Yayoi Ohashi

Address

Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61429047777

Fax

Yayoi.Ohashi@health.wa.gov.au

Contact person for public queries

Name

Yayoi Ohashi

Address

Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61429047777

Fax

Yayoi.Ohashi@health.wa.gov.au

Contact person for scientific queries

Name

Yayoi Ohashi

Address

Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61429047777

Fax

Yayoi.Ohashi@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

There is no plan to share the IPD.

What supporting documents are/will be available?

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

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