Perioperative Warming Measures in Cesarean Delivery

NCT05015582 | Terminated Results FDA Device

• 1 other identifier: HSC-MS-21-0011
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothermia, Newborn; Hypothermia, Sequela; Hypothermia; Anesthesia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Degree of Shivering (Severity)

  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)

  after administration of meperidine, if it applies (about 30 minutes in PACU)

• Maternal Thermal Comfort

  end of surgery (4 hours after anesthesia)

Study Arms (2)

Treatment

EXPERIMENTAL

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); 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)

Control Group

ACTIVE COMPARATOR

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); 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 fluids at room temperature; Device: Intra op upper body forced air warming at (32˚C)

Interventions

Pre op upper body forced air warming (32˚C) DEVICE

Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes

Control Group; Treatment

Pre op lower body forced air warming (32˚C) DEVICE

lower body forced air warming at ambient (32˚C) for at least 30 minutes

Control Group; Treatment

Pre op fluids (45˚C) DEVICE

fluids from warmed cabinet set at 45˚C

Control Group; Treatment

Intra op upper body forced air warming (32˚C) DEVICE

Use of upper body forced air warming intra-operative at ambient (32˚C)

Control Group; Treatment

Intra op fluids at room temperature DEVICE

IV fluids at room temperature

Control Group

Intra op upper body forced air warming at (32˚C) DEVICE

upper body forced air warming intra-operative at ambient (32˚C)

Control Group; Treatment

Intra op upper body forced air warming at (42˚C) DEVICE

upper body forced air warming intra-operative at ambient (42˚C)

Treatment

Intra op lower body forced air warming at (32˚C) DEVICE

Lower body forced air warming intra-operative at ambient (32˚C)

Treatment

Intra op lower body forced air warming at (42˚C) DEVICE

Lower body forced air warming intra-operative at ambient (42˚C)

Treatment

Intra op fluid (42˚C) DEVICE

IV fluids with hotline fluid warmer set at 42˚C

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• gestational age of less than 37 week
• emergency cesarean

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stacy Norrell, MD
• Organization: The University of Texas Health Science Center at Houston

Stacy.Norrell@uth.tmc.edu

713-500-6200

Study Officials

• Stacy Norrell, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 20, 2021
• Study Start: August 23, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: May 14, 2026
• Results First Posted: May 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)