This study will demonstrate whether an electric warming mattress can reduce the number of patients who get cold and shiver after elective cesarean section. Peri-operative hypothermia (body temperature below 36 ºC) is a cause of post-operative complications and patient discomfort. Immediately post-operatively such discomfort is due to increased pain and shivering. Patients say that their time in the recovery ward is very stressful and this is prolonged if they become cold (hypothermic)or shiver. Subsequently, patients can suffer with increased risk of infections and delayed discharge from hospital. For patients (and their babies) having Cesarean sections it is important to start breast feeding as soon as possible, but being cold may delay this. For some types of surgery measures are put in place to stop patients becoming cold and thereby reduce the number of problems. However this is not the case with patients undergoing Cesarean sections because the special blankets through which hot air is blown to keep them warm are inappropriate for mothers giving birth by Cesarean section as it would make it difficult for a mother to have good skin-to-skin contact with her new baby immediately after delivery - an important part in the bonding process. A solution is to use a new warming mattress. This has been shown to be safe and effective with some types of surgery, but has not been tested in Cesarean sections. In the investigators study,the investigators will warm a group of patients undergoing planned Cesarean section and compare them to an unwarmed group to see if there is any difference primarily in post-operative temperature. Secondarily, the investigators will also look for differences in total blood loss, incidence of blood transfusion, wound infection, shivering, the immediate health of the baby, time taken to become fit for discharge from recovery, length of hospital stay and time to breast-feeding.
This project will be a randomised controlled trial comparing a warming mattress with current standard of care (no warming). Prospective participants will be invited by letter and provided with a information booklet explaining the study and their rights. Informed consent will be taken in writing. Patients will be randomised using a protocol created by the Trusts Clinical Investigations Research Unit who will use an Internet based randomisation system. The researcher will not be blinded as it is not logistically feasible. The statistician analysing the results will be blinded to which group receives warming. Study data will be collected manually on a standardised data collection sheet. All enrolled patients will have their temperatures measured at specified times and will be observed for shivering. Data collection required to measure the primary outcomes will be complete by time of discharge from the recovery room. Data collection for secondary outcomes will be prospective and retrospective and will occur from time of anaesthesia through to one month after the procedure. All patients will receive routine post-operative care. To ensure any late complications are not missed we will interview the patients by phone one month after the date of their procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
116
Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively. Inditherm Alpha systems, OTM1: 1900mm x 585mm
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce Post-operative Hypothermia (Defined as Body Temperature of Less Than 36.0ºC) in Patients Undergoing Planned Caesarean Section.
IPH (body temperature of less than 36.0ºC)
Time frame: On admission to recovery room - time variable, same day as procedure
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce the Incidence of Shivering in Patients Undergoing Planned Caesarean Section.
Whether an electric warming mattress can reduce the incidence of shivering in patients undergoing planned Caesarean section. Shivering will be described according to severity on a scale of 1-4 where 1 is no shivering and 4 is uncontrolled shivering
Time frame: From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure
Differences in Total Blood Loss
Time frame: At the end of the Caesarean section - time variable
Differences in Incidence of Blood Transfusion
Time frame: From start of Caesarean section to discharge from hospital - times variable
Differences in Wound Infection Rates
Time frame: From immediately post-operative till 1 month post procedure
Differences in Shivering (Severity and the Need for Treatment)
Time frame: On admission to recovery room - time variable, same day as procedure
Differences in Immediate Health of Baby
Time frame: At time of baby's birth - same day as Caesarean section
Differences in Time Taken for Mother to Become Fit for Discharge From Recovery
Time frame: Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure
Differences in Length of Hospital Stay
Time frame: Worked out reterospectively post-discharge from hospital patient notes
Differences in Time to Breast-feeding (if Mother Chooses to Breast Feed)
Time frame: From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.