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Electric Warming Mattress to Prevent IPH During LSCS

A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01054209
Acronym
ObsIPH
Enrollment
116
Registered
2010-01-22
Start date
2010-02-28
Completion date
2011-08-31
Last updated
2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hypothermia, Obstetric Anesthesia Problems

Keywords

Inadvertent Peri-operative Hypothermia, Shivering, Caesarean Section, Elective, Warming Mattress, Regional Anaesthesia

Brief summary

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.

Detailed description

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.

Interventions

DEVICEWarming 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

Sponsors

Brighton and Sussex University Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients undergoing elective (planned) caesarean section under spinal or combined spinal and epidural (CSE) anaesthesia will be eligible.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
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.On admission to recovery room - time variable, same day as procedureIPH (body temperature of less than 36.0ºC)
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce the Incidence of Shivering in Patients Undergoing Planned Caesarean Section.From start of anaesthesia till discharge from the recovery room - time variable, same day as procedureWhether 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

Secondary

MeasureTime frame
Differences in Wound Infection RatesFrom 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 BabyAt time of baby's birth - same day as Caesarean section
Differences in Total Blood LossAt the end of the Caesarean section - time variable
Differences in Length of Hospital StayWorked 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
Differences in Time Taken for Mother to Become Fit for Discharge From RecoveryTime mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure
Differences in Incidence of Blood TransfusionFrom start of Caesarean section to discharge from hospital - times variable

Countries

United Kingdom

Participant flow

Recruitment details

February 2010- September 2012 Recruitment at preop assessment; consent on admission. Study location: obstetric ward and operating theatres

Pre-assignment details

Entry into study phase on arrival in operating theatre. Final temperature readings to in the PACU

Participants by arm

ArmCount
A Control: Standard Care
Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
58
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
58
Total116

Baseline characteristics

CharacteristicA Control: Standard CareB Intervention: Warming MattressTotal
Age, Continuous33.6 years
STANDARD_DEVIATION 5.8
34.3 years
STANDARD_DEVIATION 5.9
34.0 years
STANDARD_DEVIATION 5.8
Incidence IPH58 participants58 participants116 participants
Region of Enrollment
United Kingdom
58 participants58 participants116 participants
Sex: Female, Male
Female
58 Participants58 Participants116 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 580 / 58
serious
Total, serious adverse events
0 / 580 / 58

Outcome results

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)

Time frame: On admission to recovery room - time variable, same day as procedure

ArmMeasureValue (NUMBER)
A: Control Arm: Standard CareThis 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.58 participants
B: Intervention: Warming MattressThis 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.58 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

Time frame: From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure

Secondary

Differences in Immediate Health of Baby

Time frame: At time of baby's birth - same day as Caesarean section

Secondary

Differences in Incidence of Blood Transfusion

Time frame: From start of Caesarean section to discharge from hospital - times variable

Secondary

Differences in Length of Hospital Stay

Time frame: Worked out reterospectively post-discharge from hospital patient notes

Secondary

Differences in Shivering (Severity and the Need for Treatment)

Time frame: On admission to recovery room - time variable, same day as procedure

Secondary

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

Secondary

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

Secondary

Differences in Total Blood Loss

Time frame: At the end of the Caesarean section - time variable

Secondary

Differences in Wound Infection Rates

Time frame: From immediately post-operative till 1 month post procedure

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026