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Electric Warming Mattress to Prevent IPH During LSCS

NCT01054209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2020-07-28

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Brighton and Sussex University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Christopher M Harper, MBBS, FRCA · BSUH NHS Trust, UK

  • Abhijoy Chakladar, MRCP, FRCA · BSUH NHS Trust, UK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054209 on ClinicalTrials.gov