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Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT02837913
Recruitment Status : Terminated (Difficulty recruiting study subjects)
First Posted : July 20, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Geller, 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

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 over 2 hours ]

Secondary Outcome Measures :
  1. Shivering [ Time Frame: Continuous monitoring up to 4 hours ]
  2. Vitals: Heart rate, blood pressure, oxygen saturation, respiratory rate [ Time Frame: 3 minute intervals for up to 2 hours ]
  3. Blood loss [ Time Frame: Documented at the end of 2 hour surgical procedure ]
  4. Time to neonatal bonding [ Time Frame: time from delivery to first maternal contact during the 2 hour surgical procedure ]
  5. Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort [ Time Frame: at 15 minute intervals during the cesarean section ]


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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
United States, California
Cedars Sinai
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center

Responsible Party: Andrew Geller, Co-Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02837913     History of Changes
Other Study ID Numbers: Pro00039382
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Andrew Geller, Cedars-Sinai Medical Center:
Perioperative Warming

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms