Perioperative Warming Measures in Cesarean Delivery

Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery

The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby

Study Overview

• Status: Terminated
• Conditions: Hypothermia; Anesthesia; Hypothermia, Newborn; Hypothermia, Sequela
• Intervention / Treatment: Device: Pre op upper body forced air warming (32˚C); Device: Pre op lower body forced air warming (32˚C); Device: Pre op fluids (45˚C); Device: Intra op upper body forced air warming (32˚C); Device: Intra op upper body forced air warming at (32˚C); Device: Intra op upper body forced air warming at (42˚C); Device: Intra op lower body forced air warming at (32˚C); Device: Intra op lower body forced air warming at (42˚C); Device: Intra op fluid (42˚C); Device: Intra op fluids at room temperature

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• scheduled for elective cesarean section under neuraxial anesthesia
• singleton pregnancy

Exclusion Criteria:

• gestational age of less than 37 week
• emergency cesarean

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C	Device: Pre op upper body forced air warming (32˚C); Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes; Device: Pre op lower body forced air warming (32˚C); lower body forced air warming at ambient (32˚C) for at least 30 minutes; Device: Pre op fluids (45˚C); fluids from warmed cabinet set at 45˚C; Device: Intra op upper body forced air warming (32˚C); Use of upper body forced air warming intra-operative at ambient (32˚C); Device: Intra op upper body forced air warming at (32˚C); upper body forced air warming intra-operative at ambient (32˚C); Device: Intra op upper body forced air warming at (42˚C); upper body forced air warming intra-operative at ambient (42˚C); Device: Intra op lower body forced air warming at (32˚C); Lower body forced air warming intra-operative at ambient (32˚C); Device: Intra op lower body forced air warming at (42˚C); Lower body forced air warming intra-operative at ambient (42˚C); Device: Intra op fluid (42˚C); IV fluids with hotline fluid warmer set at 42˚C
Active Comparator: Control Group; Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature	Device: Pre op upper body forced air warming (32˚C); Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes; Device: Pre op lower body forced air warming (32˚C); lower body forced air warming at ambient (32˚C) for at least 30 minutes; Device: Pre op fluids (45˚C); fluids from warmed cabinet set at 45˚C; Device: Intra op upper body forced air warming (32˚C); Use of upper body forced air warming intra-operative at ambient (32˚C); Device: Intra op upper body forced air warming at (32˚C); upper body forced air warming intra-operative at ambient (32˚C); Device: Intra op fluids at room temperature; IV fluids at room temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Core Body Temperature		preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia)
Number of Women With Hypothermia	Hypothermia is indicated as core temperature < 36 °C	preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Neonate Status as Determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score	The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.	1 minutes after birth, 5 minutes after birth
Umbilical Artery pH		10 minutes after birth
Maternal Coagulopathy		end of surgery (4 hours after anesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay		Time of admission to time of discharge (about 72 hours after surgery)
Degree of Shivering (Severity)	Degree of shivering is measured from 0(no shivering)-3(total body shivering), a higher score indicates greater shivering.	on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]
Number of Patients That Need Meperidine		on arrival to PACU [about 4 hours after anesthesia]
Number of Patients That Need Meperidine		after 30 minutes in PACU
Degree of Shivering (Severity)	Degree of shivering is measured from 0(no shivering)-3(total body shivering)	after administration of meperidine, if it applies (about 30 minutes in PACU)
Maternal Thermal Comfort	Maternal thermal comfort has a total score range from 0 to 10,a higher number indicating more thermal comfort	end of surgery (4 hours after anesthesia)
Perioperative Blood Loss		end of surgery (4 hours after anesthesia)
Neonate Blood Sugar Level		10 minutes after birth

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Stacy Norrell, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): December 14, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypothermia
• Other Study ID Numbers: HSC-MS-21-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No