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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: standard care, no warming | No Intervention | Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician | |
| B: electric warming mattress | Active Comparator | Warming with warming mattress |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warming with warming mattress | Device | Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively. Inditherm Alpha systems, OTM1: 1900mm x 585mm |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Total Blood Loss | At the end of the Caesarean section - time variable | |
| Differences in Incidence of Blood Transfusion | From start of Caesarean section to discharge from hospital - times variable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher M Harper, MBBS, FRCA | BSUH NHS Trust, UK | Study Chair |
| Abhijoy Chakladar, MRCP, FRCA | BSUH NHS Trust, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brighton and Sussex University Hospitals NHS Trust | Brighton | East Sussex | BN25BE | United Kingdom |
Entry into study phase on arrival in operating theatre. Final temperature readings to in the PACU
February 2010- September 2012 Recruitment at preop assessment; consent on admission. Study location: obstetric ward and operating theatres
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| ID | Title | Description |
|---|---|---|
| FG000 | A Control: Standard Care | Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician |
| FG001 | B Intervention: Warming Mattress | Warming mattress activated otherwise same management as Arm A. Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively. Inditherm Alpha systems, OTM1: 1900mm x 585mm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A Control: Standard Care | Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician |
| BG001 | B Intervention: Warming Mattress |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | 95% Confidence Interval | participants | On admission to recovery room - time variable, same day as procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Control: Standard Care | Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mark Harper | Brighton and Sussex University Hospitals Trust | 01273696955 | 4307 | mark.harper@bsuh.nhs.uk |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Differences in Wound Infection Rates | From immediately post-operative till 1 month post procedure |
| Differences in Shivering (Severity and the Need for Treatment) | On admission to recovery room - time variable, same day as procedure |
| Differences in Immediate Health of Baby | 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 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 | Worked out reterospectively post-discharge from hospital patient notes |
| Differences in Time to Breast-feeding (if Mother Chooses to Breast Feed) | From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs |
Warming mattress activated otherwise same management as Arm A.
Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.
Inditherm Alpha systems, OTM1: 1900mm x 585mm
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Incidence IPH | Number | participants |
|
|
|
| Primary | 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 | Not Posted | Jul 2020 | From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure | Participants |
| Secondary | Differences in Total Blood Loss | Not Posted | At the end of the Caesarean section - time variable | Participants |
| Secondary | Differences in Incidence of Blood Transfusion | Not Posted | From start of Caesarean section to discharge from hospital - times variable | Participants |
| Secondary | Differences in Wound Infection Rates | Not Posted | From immediately post-operative till 1 month post procedure | Participants |
| Secondary | Differences in Shivering (Severity and the Need for Treatment) | Not Posted | On admission to recovery room - time variable, same day as procedure | Participants |
| Secondary | Differences in Immediate Health of Baby | Not Posted | At time of baby's birth - same day as Caesarean section | Participants |
| Secondary | Differences in Time Taken for Mother to Become Fit for Discharge From Recovery | Not Posted | Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure | Participants |
| Secondary | Differences in Length of Hospital Stay | Not Posted | Worked out reterospectively post-discharge from hospital patient notes | Participants |
| Secondary | Differences in Time to Breast-feeding (if Mother Chooses to Breast Feed) | Not Posted | From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs | Participants |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | B Intervention: Warming Mattress | Warming mattress activated otherwise same management as Arm A. Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively. Inditherm Alpha systems, OTM1: 1900mm x 585mm | 0 | 58 | 0 | 58 |
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