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

NCT ID: NCT05314075

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-27

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Upper Body

Group Type ACTIVE_COMPARATOR

Upper Body Forced Air Warming device

Intervention Type PROCEDURE

Patients will have the Bair Hugger placed over the body

Under body

Group Type ACTIVE_COMPARATOR

Under Body Forced Air Warming device

Intervention Type PROCEDURE

Patients will have the Bair Hugger placed under the body

Interventions

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Upper Body Forced Air Warming device

Patients will have the Bair Hugger placed over the body

Intervention Type PROCEDURE

Under Body Forced Air Warming device

Patients will have the Bair Hugger placed under the body

Intervention Type PROCEDURE

Other Intervention Names

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Bair Hugger Bair Hugger

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fatoumata Kromah, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM20024184

Identifier Type: -

Identifier Source: org_study_id

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