Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

Cedars-Sinai Medical Center

Status: Terminated

Conditions: Postoperative Hypothermia

Treatments: Device: VitaHeat underbody heating mattress

Study type: Interventional

Funder types: Other

Identifiers

NCT02837913

Pro00039382

Details and patient eligibility

About

The primary aim of the current study will be to determine if the use of an underbody heating mattress during cesarean sections will decrease the incidence of postoperative hypothermia, defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia. As part of the primary outcome the difference in the incidence of shivering, its severity, and need for treatment will be investigated. As a secondary goal other maternal perioperative outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to skin' contact. The relationship between maternal hypothermia and newborn outcomes of temperature and APGAR scores will also be evaluated.

Active preoperative and intraoperative warming may prevents inadvertent perioperative hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The underbody warming mattress may be a step towards finding a suitable form of warming that is comfortable for awake patients, does not interfere with skin to skin contact and maternal-fetal bonding.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• will be age >18 years,
• singleton pregnancy >37 weeks,
• neuraxial anesthesia,
• healthy afebrile patients.

Exclusion criteria

• • will be age >18 years,

  • singleton pregnancy >37 weeks,
  • neuraxial anesthesia,
  • healthy afebrile patients.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Underbody warmer on

Experimental group

Description:

Underbody warmer will be underneath the patient and turned on.

Treatment:

Device: VitaHeat underbody heating mattress

Underbody warmer off

Placebo Comparator group

Description:

Underbody warmer will be underneath the patient but not turned on.

Treatment:

Device: VitaHeat underbody heating mattress