NCT02837913

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

June 5, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 18, 2018

Completed
Last Updated

September 18, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

July 6, 2016

Results QC Date

August 23, 2018

Last Update Submit

August 26, 2019

Conditions

Postoperative Hypothermia

Keywords

Perioperative Warming

Outcome Measures

Primary Outcomes (1)

  • Temperature

    Temperature at time of post anesthesia care unit admission

    15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit

Secondary Outcomes (7)

  • Number of Participants With Shivering

    15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit

  • Vitals: Heart Rate

    Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals

  • Blood Loss

    Documented at the end of 2 hour surgical procedure

  • Time to Neonatal Bonding

    time from delivery to first maternal contact during the 2 hour surgical procedure

  • Thermal Comfort Visual Analog Scale

    Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals

  • +2 more secondary outcomes

Study Arms (2)

Underbody warmer on

EXPERIMENTAL

Underbody warmer will be underneath the patient and turned on.

Device: VitaHeat underbody heating mattress

Underbody warmer off

PLACEBO COMPARATOR

Underbody warmer will be underneath the patient but not turned on.

Device: VitaHeat underbody heating mattress

Interventions

VitaHeat underbody heating mattressDEVICE

Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively

Underbody warmer offUnderbody warmer on

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

Results Point of Contact

Title
Dr. Mark Zakowski
Organization
Cedars-Sinai Medical Center
mark.zakowski@cshs.org
310-423-5841

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 20, 2016

Study Start

June 5, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

September 18, 2019

Results First Posted

October 18, 2018

Record last verified: 2019-08

Locations

US(1)