RecruitingNot ApplicableNCT04938219

Shivering_Basel_Baden

Treatment of Intraoperative Shivering During Caesarean Section With Gloves Filled With Warm Water: a Multicentric, Randomised, Controlled Trial


Sponsor

University Hospital, Basel, Switzerland

Enrollment

200 participants

Start Date

Jun 24, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Shivering is known to occur in around 40% of women as a side effect of neuraxial anaesthesia during caesarean section.Women undergoing caesarean section under neuraxial anaesthesia are randomised into either the treatment group or control group. Women in both groups are observed during caesarean section. This study is to test a non-pharmacological and non-invasive treatment with two groups, an intervention and a control group. In the intervention group, intraoperative shivering during caesarean section is treated by placing two surgical gloves filled with warm water into the women's hands. In the control group, women will be treated with the current standard of care, which does not include specific treatment of shivering.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • Ability to give informed consent
  • Age older than 18 years and younger than 40 years.
  • Gestational age \>36 weeks
  • Shivering during regional anaesthesia for caesarean section

Exclusion Criteria4

  • Inability to give informed consent
  • Latex allergy
  • Receiving combined spinal epidural anaesthesia (CSEA)
  • Secondary spinal anaesthesia for caesarean section in patients with unsatisfactory epidural labour analgesia

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Interventions

OTHERGloves filled with warm tap water

The intervention in the treatment group will consist of nonsterile gloves, filled with regular tap water at a comfortable warm temperature and sealed with a plastic clip. The temperature of the water will not be measured, the investigators will take a temperature that feels comfortable in their hands


Locations(2)

Kantonsspital Baden AG, Department of Anaesthesiology

Baden, Canton of Aargau, Switzerland

University Hospital Basel; Department of Anaesthesiology

Basel, Switzerland

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NCT04938219


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