RecruitingACTRN12622001214729

Body temperature and shivering during caesarean sections

Accurate measurement of core body temperature and shivering occurrence in emergency caesarean sections compared to elective caesarean sections


Sponsor

Fiona Stanley Hospital

Enrollment

50 participants

Start Date

Nov 7, 2023

Study Type

Observational

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When women have a caesarean section (C-section) under spinal or epidural anaesthesia, their body temperature can shift in unexpected ways — sometimes dropping too low (hypothermia) and sometimes running too high (hyperthermia), depending on whether the surgery is planned or is happening during labour. Both extremes can cause problems for the mother and baby, and one of the most distressing side effects is shivering, which makes it very difficult for mothers to hold and breastfeed their newborn right after delivery. Currently, body temperature is not routinely checked during caesareans, which means warming or cooling measures cannot be tailored to each person's needs. This study will carefully measure and compare temperature patterns in two groups: women having a planned (elective) caesarean under spinal anaesthesia, and women having an emergency caesarean during labour under epidural anaesthesia. By understanding how temperature differs between these groups, researchers hope to develop better, more personalised care. You may be eligible if you are 18 or older and are having either a planned C-section under spinal anaesthesia or an intrapartum emergency C-section under epidural anaesthesia. Women with very high health risk ratings (ASA 3 or above), extreme obesity (BMI 50 or over), the most urgent category of emergency caesarean, or those already planned for warming blankets from the start of surgery would not be included.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 atta

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.


Locations(2)

Fiona Stanley Hospital - Murdoch

WA, Australia

London, United Kingdom

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ACTRN12622001214729


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