Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

NCT ID: NCT02837913

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2018-01-01

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.

Conditions

Postoperative Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Underbody warmer on

Underbody warmer will be underneath the patient and turned on.

Group Type: EXPERIMENTAL

VitaHeat underbody heating mattress

Intervention Type: DEVICE

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

Underbody warmer off

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

Group Type: PLACEBO_COMPARATOR

VitaHeat underbody heating mattress

Intervention Type: DEVICE

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

Interventions

VitaHeat underbody heating mattress

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mark Zakowski MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cedars Sinai

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00039382

Identifier Type: -

Identifier Source: org_study_id