Clinical trial NCT02837913: Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
Official title: Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postoperative Hypothermia
Keywords: Perioperative Warming
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Temperature
timeFrame: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
Secondary outcomes:
measure: Number of Participants With Shivering
timeFrame: 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit
measure: Vitals: Heart Rate
timeFrame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
measure: Blood Loss
timeFrame: Documented at the end of 2 hour surgical procedure
measure: Time to Neonatal Bonding
timeFrame: time from delivery to first maternal contact during the 2 hour surgical procedure
measure: Thermal Comfort Visual Analog Scale
timeFrame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
measure: Vitals: Oxygen Saturation
timeFrame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
measure: Vitals: Blood Pressure
timeFrame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
Study officials:
References: