Cesarean SectionNCT05314075
Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)
A study testing Upper Body Forced Air Warming device and Under Body Forced Air Warming device in people with Cesarean Section, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Upper Body Forced Air Warming device and Under Body Forced Air Warming device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age =/> 18 years
- Elective non-emergent C-section
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Cesarean Section
- Being tested
- Upper Body Forced Air Warming device, Under Body Forced Air Warming device
- Keywords
- Thermoregulation, Forced air warming, upper or lower body forced air cover, core body temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Body Forced Air Warming deviceProcedure or surgery
Also called Bair Hugger
Patients will have the Bair Hugger placed over the body
Under Body Forced Air Warming deviceProcedure or surgery
Also called Bair Hugger
Patients will have the Bair Hugger placed under the body
| Study group | Role | What they receive |
|---|---|---|
| Upper Body | Active comparator | Not described Receives: Procedure: Upper Body Forced Air Warming device |
| Under body | Active comparator | Not described Receives: Procedure: Under Body Forced Air Warming device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature
Maternal core temperatures will be measured using a temperature sensing Foley catheter
Measured: 1 hour post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start27 Dec 2022
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatoumata Kromah, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314075
- Sponsor's protocol ID
- HM20024184
- Status last verified
- Aug 2025
- First submitted
- 29 Mar 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)
- ClinicalTrials.gov ID
- NCT05314075
- Acronym / sponsor ID
- HM20024184
- Conditions
- Cesarean Section
- Keywords
- Thermoregulation, Forced air warming, upper or lower body forced air cover, core body temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Body | Active comparator | Procedure: Upper Body Forced Air Warming device |
| Under body | Active comparator | Procedure: Under Body Forced Air Warming device |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age =/> 18 years
- Elective non-emergent C-section
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Body Forced Air Warming deviceAlso: Bair HuggerPatients will have the Bair Hugger placed over the body | Procedure or surgery | Upper Body |
| Under Body Forced Air Warming deviceAlso: Bair HuggerPatients will have the Bair Hugger placed under the body | Procedure or surgery | Under body |
Primary outcome
Core body temperature
Time frame: 1 hour post surgery
Maternal core temperatures will be measured using a temperature sensing Foley catheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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Implementation of a Disparities in Labor Outcomes Dashboard
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatoumata Kromah, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Body Forced Air Warming device and Under Body Forced Air Warming device in people with Cesarean Section, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core body temperature (time frame: 1 hour post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.