ObsIPH: Electric Warming Mattress to Prevent IPH During LSCS

• Sponsor: Brighton and Sussex University Hospitals NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT01054209
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia; Anesthesia; Obstetric Anesthesia Problems	Device: Warming with warming mattress	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: A: standard care, no warming Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
Active Comparator: B: electric warming mattress Warming with warming mattress	Device: 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; Other Names: Inditherm Alpha systems, OTM1: 1900mm x 585mm

Outcome Measures

Primary Outcome Measures

1. 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 procedure]

   IPH (body temperature of less than 36.0ºC)

2. 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 procedure]

   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

Secondary Outcome Measures

1. Differences in Total Blood Loss [At the end of the Caesarean section - time variable]

2. Differences in Incidence of Blood Transfusion [From start of Caesarean section to discharge from hospital - times variable]

3. Differences in Wound Infection Rates [From immediately post-operative till 1 month post procedure]

4. Differences in Shivering (Severity and the Need for Treatment) [On admission to recovery room - time variable, same day as procedure]

5. Differences in Immediate Health of Baby [At time of baby's birth - same day as Caesarean section]

6. 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]

7. Differences in Length of Hospital Stay [Worked out reterospectively post-discharge from hospital patient notes]

8. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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:

• Exclusion criteria will be those who refuse, who are unable to fully understand the trial or are under 16 years of age when presenting for their Caesarean section.

• Those that are unable to understand for language issues are excluded with regret due to the difficulties of obtaining interpreters at the time of caesarean section, in recovery and once at home for the telephone interview. Waiting for additional interpretation may delay the clinical management of the patient and also the patient may not be able to convey questions or concerns about the study through mail, email or telephone prior to attending.

• Patients under 16 years of age will be excluded from the trial for reasons of consent. Although a patient less than 16 years of age may have Gillick competence and therefore have the capacity to consent to take part in this trial, as a minor their parents may have concerns leading them to refuse trial entry. Child birth in minors can be very stressful for the patient, family and clinical team and we are keen not to add to this for the purposes of a study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brighton and Sussex University Hospitals NHS Trust	Brighton	East Sussex	United Kingdom	BN25BE

Sponsors and Collaborators

• Brighton and Sussex University Hospitals NHS Trust

Investigators

• Study Chair: Christopher M Harper, MBBS, FRCA, BSUH NHS Trust, UK
• Principal Investigator: Abhijoy Chakladar, MRCP, FRCA, BSUH NHS Trust, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr C. Mark Harper, Consultant Anaesthetist, Brighton and Sussex University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT01054209
• Other Study ID Numbers: 09/165/HAR
• First Posted: Jan 22, 2010
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Dr C. Mark Harper, Consultant Anaesthetist, Brighton and Sussex University Hospitals NHS Trust: Inadvertent Peri-operative Hypothermia; Shivering; Caesarean Section; Elective; Warming Mattress; Regional Anaesthesia
• Additional relevant MeSH terms: Hypothermia

Study Results

Participant Flow

Recruitment Details	February 2010- September 2012 Recruitment at preop assessment; consent on admission. Study location: obstetric ward and operating theatres
Pre-assignment Detail	Entry into study phase on arrival in operating theatre. Final temperature readings to in the PACU

Arm/Group Title	A Control: Standard Care	B Intervention: Warming Mattress
Arm/Group Description	Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician	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
Period Title: Overall Study
STARTED	58	58
COMPLETED	58	58
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	A Control: Standard Care	B Intervention: Warming Mattress	Total
Arm/Group Description	Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician	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	Total of all reporting groups
Overall Participants	58	58	116
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.6 (5.8)	34.3 (5.9)	34.0 (5.8)
Sex: Female, Male (Count of Participants)
Female	58 100%	58 100%	116 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	58 100%	58 100%	116 100%
Incidence IPH (participants) [Number]
Number [participants]	58 100%	58 100%	116 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	IPH (body temperature of less than 36.0ºC)
Time Frame	On admission to recovery room - time variable, same day as procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A: Control Arm: Standard Care	B: Intervention: Warming Mattress
Arm/Group Description	Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician	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
Measure Participants	58	58
Number (95% Confidence Interval) [participants]	58 100%	58 100%

2. Primary Outcome

Title	This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce the Incidence of Shivering in Patients Undergoing Planned Caesarean Section.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Differences in Total Blood Loss
Time Frame	At the end of the Caesarean section - time variable

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Differences in Incidence of Blood Transfusion
Time Frame	From start of Caesarean section to discharge from hospital - times variable

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Differences in Wound Infection Rates
Time Frame	From immediately post-operative till 1 month post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Differences in Shivering (Severity and the Need for Treatment)
Time Frame	On admission to recovery room - time variable, same day as procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Differences in Immediate Health of Baby
Time Frame	At time of baby's birth - same day as Caesarean section

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Differences in Length of Hospital Stay
Time Frame	Worked out reterospectively post-discharge from hospital patient notes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	A Control: Standard Care		B Intervention: Warming Mattress
Arm/Group Description	Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician		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
All Cause Mortality
	A Control: Standard Care		B Intervention: Warming Mattress
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	A Control: Standard Care		B Intervention: Warming Mattress
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/58 (0%)
Other (Not Including Serious) Adverse Events
	A Control: Standard Care		B Intervention: Warming Mattress
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/58 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.