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Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837913
Recruitment Status : Terminated (Difficulty recruiting study subjects)
First Posted : July 20, 2016
Results First Posted : October 18, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Zakowski MD, Cedars-Sinai Medical Center

Brief Summary:

The primary aim of the current study will be to determine if the use of an underbody heating mattress during cesarean sections will decrease the incidence of postoperative hypothermia, defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia. As part of the primary outcome the difference in the incidence of shivering, its severity, and need for treatment will be investigated. As a secondary goal other maternal perioperative outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to skin' contact. The relationship between maternal hypothermia and newborn outcomes of temperature and APGAR scores will also be evaluated.

Active preoperative and intraoperative warming may prevents inadvertent perioperative hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The underbody warming mattress may be a step towards finding a suitable form of warming that is comfortable for awake patients, does not interfere with skin to skin contact and maternal-fetal bonding.


Condition or disease Intervention/treatment Phase
Postoperative Hypothermia Device: VitaHeat underbody heating mattress Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Underbody warmer on
Underbody warmer will be underneath the patient and turned on.
Device: VitaHeat underbody heating mattress
Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively

Placebo Comparator: Underbody warmer off
Underbody warmer will be underneath the patient but not turned on.
Device: VitaHeat underbody heating mattress
Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively




Primary Outcome Measures :
  1. Temperature [ Time Frame: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit ]
    Temperature at time of post anesthesia care unit admission


Secondary Outcome Measures :
  1. Number of Participants With Shivering [ Time Frame: 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit ]
    Shivering at time of post anesthesia care unit admission

  2. Vitals: Heart Rate [ Time Frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals ]
    Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit

  3. Blood Loss [ Time Frame: Documented at the end of 2 hour surgical procedure ]
    Estimated blood loss with and without warming

  4. Time to Neonatal Bonding [ Time Frame: time from delivery to first maternal contact during the 2 hour surgical procedure ]
    time to neonatal bonding as skin to skin

  5. Thermal Comfort Visual Analog Scale [ Time Frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals ]
    Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold

  6. Vitals: Oxygen Saturation [ Time Frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals ]
    Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit

  7. Vitals: Blood Pressure [ Time Frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals ]
    Vitals: blood pressure as mean arterial pressure



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • will be age >18 years,
  • singleton pregnancy >37 weeks,
  • neuraxial anesthesia,
  • healthy afebrile patients.

Exclusion Criteria:

  • • will be age >18 years,

    • singleton pregnancy >37 weeks,
    • neuraxial anesthesia,
    • healthy afebrile patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837913


Locations
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United States, California
Cedars Sinai
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Mark Zakowski MD, Cedars-Sinai Medical Center:
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Responsible Party: Mark Zakowski MD, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02837913    
Other Study ID Numbers: Pro00039382
First Posted: July 20, 2016    Key Record Dates
Results First Posted: October 18, 2018
Last Update Posted: September 18, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mark Zakowski MD, Cedars-Sinai Medical Center:
Perioperative Warming
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms