Electric Warming Mattress to Prevent IPH During LSCS

NCT01054209 | Completed Results DMC

• 1 other identifier: 09/165/HAR
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Anesthesia; Obstetric Anesthesia Problems

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• 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

• 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

Study Arms (2)

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

Device: Warming with warming mattress

Interventions

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

Also known as: Inditherm Alpha systems, OTM1: 1900mm x 585mm

B: electric warming mattress

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead

Study Sites (1)

Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, BN25BE, United Kingdom

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Mark Harper
• Organization: Brighton and Sussex University Hospitals Trust

mark.harper@bsuh.nhs.uk

01273696955

Study Officials

• Christopher M Harper, MBBS, FRCA

  BSUH NHS Trust, UK

  STUDY CHAIR

• Abhijoy Chakladar, MRCP, FRCA

  BSUH NHS Trust, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 28, 2020
• Results First Posted: November 5, 2018

Record last verified: 2020-07

Locations

GB (1)