NCT05314075

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

December 27, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

March 29, 2022

Last Update Submit

August 29, 2025

Conditions

Cesarean Section

Keywords

ThermoregulationForced air warmingupper or lower body forced air covercore body temperature

Outcome Measures

Primary Outcomes (1)

  • Core body temperature

    Maternal core temperatures will be measured using a temperature sensing Foley catheter

    1 hour post surgery

Study Arms (2)

Upper Body

ACTIVE COMPARATOR
Procedure: Upper Body Forced Air Warming device

Under body

ACTIVE COMPARATOR
Procedure: Under Body Forced Air Warming device

Interventions

Upper Body Forced Air Warming devicePROCEDURE

Patients will have the Bair Hugger placed over the body

Also known as: Bair Hugger
Upper Body
Under Body Forced Air Warming devicePROCEDURE

Patients will have the Bair Hugger placed under the body

Also known as: Bair Hugger
Under body

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Fatoumata Kromah, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

December 27, 2022

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)