Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)

August 29, 2025 updated by: Virginia Commonwealth University
This study is intended to calculate the core body temperature in patients who are having a Cesarean Section (C/S) and are kept warm with an Upper Body Forced Air Warming device (Bair Hugger) or underbody forced air warmer. These warming devices are approved and are a required item in many if not all surgical procedures. They are used daily throughout the hospital. The research question is: Where is the best place to position the warming blanket in pregnant mothers undergoing Cesarean section delivery. The researchers hope to compare post - operative core body temperatures in patients getting an Upper Body forced air device versus those getting an Underbody Body forced air warming device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age =/> 18 years
  • Elective non-emergent C-section

Exclusion Criteria:

  • BMI<18/>40
  • Bleeding Disorders e.g. hemophilia, coagulation abnormality, clotting disorders, bleeding diathesis
  • Perioperative hemorrhage >1500ml
  • Non-Singleton Pregnancies
  • Complicated Pregnancy (e.g. Eclampsia, Pre-eclampsia)
  • Conversion to Emergency C-section
  • Endocrine Pathology- e.g. Thyroid Disease, Insulin Dependent Diabetes
  • Inmates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Upper Body
Procedure: Upper Body Forced Air Warming device
Patients will have the Bair Hugger placed over the body
Other Names:
  • Bair Hugger
Active Comparator: Under body
Procedure: Under Body Forced Air Warming device
Patients will have the Bair Hugger placed under the body
Other Names:
  • Bair Hugger

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core body temperature
Time Frame: 1 hour post surgery
Maternal core temperatures will be measured using a temperature sensing Foley catheter
1 hour post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Fatoumata Kromah, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2022

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM20024184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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