Upper Body Warming vs Under Body Warming for Cesarean Section

Overseen By Donna Ells

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Bmi<18/>40, Bleeding disorders, Complicated pregnancy, Endocrine pathology, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Under Body Forced Air Warming device and Upper Body Forced Air Warming device for preventing hypothermia during cesarean section?

Research shows that forced-air warming, whether applied to the full body, upper body, or lower body, significantly reduces the incidence of hypothermia and shivering in women undergoing cesarean sections, compared to those who do not receive this treatment. ^{1 2 3 4 5}

Is forced-air warming safe for use in surgeries?

Research shows that forced-air warming devices, used to keep patients warm during surgery, do not increase the risk of infections and are considered safe for use in various surgical procedures. ^{2 4 5 6 7}

How does the treatment of upper body warming vs under body warming for cesarean section differ from other treatments?

This treatment is unique because it uses forced-air warming devices to target specific body areas, either the upper or under body, to prevent hypothermia (dangerously low body temperature) during cesarean sections. Unlike other methods, it focuses on maintaining body temperature by warming specific regions, which can reduce shivering and improve thermal comfort during and after surgery. ^{1 2 4 8 9}

Research Team

Fatoumata Kromah, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for women over 18 years old having a planned Cesarean Section without emergency complications. Candidates must not have bleeding disorders, extreme body weight, multiple pregnancies, severe pregnancy-related conditions like eclampsia or pre-eclampsia, or significant hormonal diseases.

Inclusion Criteria

Age greater than or equal to 18 years

Elective non-emergent C-section

Exclusion Criteria

Bleeding Disorders such as hemophilia, coagulation abnormality, clotting disorders, or bleeding diathesis

You weigh too little or too much for your height.

You are currently in jail or prison.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo Cesarean Section with either Upper Body or Underbody Forced Air Warming device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for core body temperature 1 hour post-surgery

1 hour

1 visit (in-person)

Treatment Details

Interventions

• Under Body Forced Air Warming device
• Upper Body Forced Air Warming device

Trial Overview The study compares the effectiveness of two types of warming devices during C-sections: one that warms the upper body and another that warms underneath the body. The goal is to determine which positioning results in better post-operative core body temperature maintenance.

Participant Groups

Group I: Upper Body Active Control 1 Intervention

Group II: Under body Active Control 1 Intervention

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of forced-air warming in the cesarean section on maternal hypothermia, shivering, and thermal comfort: A randomized controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of forced-air warming systems with upper body blankets using a copper manikin of the human body. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial. [2016]

4. France pubmed.ncbi.nlm.nih.gov

Preoperative warming and undesired surgical and anesthesia outcomes in pediatric spinal surgery-a retrospective cohort study. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Randomised trial comparing forced-air warming to the upper or lower body to prevent hypothermia during thoracoscopic surgery in the lateral decubitus position. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

No Evidence of Increased Infection Risk with Forced-Air Warming Devices: A Systematic Review. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of resistive polymer versus forced air warming in total joint surgery. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

An evaluation of a full-access underbody forced-air warming system during near-normothermic, on-pump cardiac surgery. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Preventing Hypothermia during Cesarean Birth: An Integrative Review. [2020]