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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for keeping patients warm during a Cesarean section (C-section) by using either an upper body or underbody warming device. Both devices are commonly used in surgeries to maintain body temperature. The researchers seek to identify if one method better stabilizes patients' core temperature after surgery. The study is recruiting pregnant women scheduled for a planned C-section who do not have certain medical conditions, such as bleeding disorders or a high-risk pregnancy. As an unphased trial, participants can help improve surgical care for future patients.

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 prior data suggests that these warming devices are safe for use during Cesarean sections?

Research has shown that the warming devices used in this study are safe for surgeries, including C-sections. Studies indicate these devices help maintain patient warmth, reducing the risk of shivering and very low body temperature during procedures. Importantly, using these devices does not increase infection risk, making them common in many surgeries. Both upper body and underbody warming devices offer similar benefits in keeping patients comfortable and maintaining stable body temperature. Overall, hospitals widely use these well-tolerated warming devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing upper body warming to under body warming during cesarean sections because it could enhance patient comfort and safety. Most current options for maintaining body temperature during surgery, like warmed IV fluids or blankets, might not be as effective or targeted. By investigating whether warming the upper or lower body is more beneficial, this trial seeks to optimize the warming technique, potentially leading to better outcomes such as reduced shivering and improved recovery times. This could represent a simple yet meaningful improvement in surgical care for mothers undergoing cesarean sections.

What evidence suggests that these warming devices are effective for maintaining core body temperature during Cesarean sections?

Research has shown that forced-air warming devices used during C-sections help maintain the mother's body temperature. This trial will compare two types of warming devices: the Upper Body Forced Air Warming device and the Under Body Forced Air Warming device. Studies have found that both types effectively reduce the risk of hypothermia and shivering. Specifically, patients using these devices experience less of a temperature drop and feel more comfortable during and after surgery. However, while these devices help keep the mother warm, they do not completely prevent hypothermia in newborns. Overall, both warming devices are effective in maintaining warmth during C-sections. ^{1 2 6 7 8}

Who Is on the Research Team?

Fatoumata Kromah, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4574493/

The Effect of patient warming during Caesarean delivery on ... Active warming for elective Caesarean delivery decreases perioperative temperature reduction and the incidence of hypothermia and shivering.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0104001421003961

Forced-air warming and continuous core temperature ... Forced-air warming decreases perioperative hypothermia in parturients undergoing cesarean section but does not entirely prevent hypothermia in newborns while ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70358

Effectiveness of active warming to prevent shivering during ... This study shows that women who receive commonly used AW techniques, either alone or in combination, have a lower risk of shivering and ...

4. jopan.org jopan.org/article/S1089-9472(23)00210-1/fulltext

Prewarming Parturients for Cesarean Section Does Not ... Prewarming before cesarean section under spinal anesthesia maintains core temperature and improves patient comfort but does not affect wound temperature.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04667000

The Effect of Forced Air Warming During Caseraen Section ... This study was planned as a parallel group randomized controlled study in order to determine the effect of heating different body parts using forced air warming ...

6. pssjournal.biomedcentral.com pssjournal.biomedcentral.com/articles/10.1186/s13037-020-00241-x

Improving intraoperative temperature management in elective ... Numerous publications have documented favorable outcomes with forced-air warming, underbody warming blankets, and warmed intravenous/irrigation ...

7. heraldopenaccess.us heraldopenaccess.us/openaccess/efficacy-and-safety-of-forced-air-warming-system-versus-passive-warming-measures-in-major-surgeries-a-systematic-review

Efficacy and Safety of Forced-Air Warming System versus ... Compared to passive warming, Bair Hugger has significant advantages in hypothermia protection and further reduces the risk of incision chills and prolonged ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03581721

Prevention of Maternal Hypothermia After Scheduled ... Intraoperative forced air-warming during cesarean delivery under spinal anesthesia does not prevent maternal hypothermia. Anesth Analg. 2007 Nov;105(5):1413 ...