Trial Outcomes & Findings for Electric Warming Mattress to Prevent IPH During LSCS (NCT NCT01054209)

Results Overview

IPH (body temperature of less than 36.0ºC)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

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

Results posted on

2020-07-28

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	A Control: Standard Care Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician	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
Overall Study STARTED	58	58
Overall Study COMPLETED	58	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electric Warming Mattress to Prevent IPH During LSCS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A Control: Standard Care n=58 Participants Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician	B Intervention: Warming Mattress n=58 Participants 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 n=116 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 5.8 • n=39 Participants	34.3 years STANDARD_DEVIATION 5.9 • n=41 Participants	34.0 years STANDARD_DEVIATION 5.8 • n=35 Participants
Sex: Female, Male Female	58 Participants n=39 Participants	58 Participants n=41 Participants	116 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United Kingdom	58 participants n=39 Participants	58 participants n=41 Participants	116 participants n=35 Participants
Incidence IPH	58 participants n=39 Participants	58 participants n=41 Participants	116 participants n=35 Participants

PRIMARY outcome

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

IPH (body temperature of less than 36.0ºC)

Outcome measures

Outcome measures
Measure	A: Control Arm: Standard Care n=58 Participants Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician	B: Intervention: Warming Mattress n=58 Participants 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
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.	58 participants Interval 57.0 to 59.0	58 participants Interval 57.0 to 59.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of the Caesarean section - time variable

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From immediately post-operative till 1 month post procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Worked out reterospectively post-discharge from hospital patient notes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs

Outcome measures

Outcome data not reported

Adverse Events

A Control: Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B Intervention: Warming Mattress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mark Harper

Brighton and Sussex University Hospitals Trust

Phone: 01273696955

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place