Measuring core body temperature during Cesarean sections with different warming methods
Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)
NA · Virginia Commonwealth University · NCT05314075
This study is testing whether warming patients' upper or lower body during a Cesarean section helps keep their core body temperature more stable after the surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Virginia Commonwealth University (other) |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05314075 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the most effective placement of forced air warming devices for maintaining core body temperature in patients undergoing elective Cesarean sections. Participants will be randomly assigned to receive either upper body or underbody warming during the procedure. The primary focus is to compare postoperative core body temperatures between the two groups to identify which method is more effective. The study utilizes approved warming devices that are commonly used in surgical settings.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older scheduled for elective non-emergent Cesarean sections.
Not a fit: Patients with extreme BMI, bleeding disorders, complicated pregnancies, or those requiring emergency C-sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient comfort and safety during Cesarean sections by optimizing temperature management.
How similar studies have performed: While the use of forced air warming devices is common, this specific comparison of upper versus underbody placement is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Fatoumata Kromah, MD — Virginia Commonwealth University
- Study coordinator: Fatoumata Kromah, MD
- Email: fatoumata.kromah@vcuhealth.org
- Phone: 804-828-5021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cesarean Section, Thermoregulation, Forced air warming, upper or lower body forced air cover, core body temperature