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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05015582
Other study ID # HSC-MS-21-0011
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 23, 2021
Est. completion date August 1, 2023

Study information

Verified date January 2023
Source The University of Texas Health Science Center, Houston
Contact Stacy Norrell, MD
Phone (713) 500-6200
Email Stacy.Norrell@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - scheduled for elective cesarean section under neuraxial anesthesia - singleton pregnancy Exclusion Criteria: - gestational age of less than 37 week - emergency cesarean

Study Design


Related Conditions & MeSH terms


Intervention

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
Pre op lower body forced air warming (32°C)
lower body forced air warming at ambient (32°C) for at least 30 minutes
Pre op fluids (45°C)
fluids from warmed cabinet set at 45°C
Intra op upper body forced air warming (32°C)
Use of upper body forced air warming intra-operative at ambient (32°C)
Intra op fluids at room temperature
IV fluids at room temperature
Intra op upper body forced air warming at (32°C)
upper body forced air warming intra-operative at ambient (32°C)
Intra op upper body forced air warming at (42°C)
upper body forced air warming intra-operative at ambient (42°C)
Intra op lower body forced air warming at (32°C)
Lower body forced air warming intra-operative at ambient (32°C)
Intra op lower body forced air warming at (42°C)
Lower body forced air warming intra-operative at ambient (42°C)
Intra op fluid (42°C)
IV fluids with hotline fluid warmer set at 42°C

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in maternal core body temperature preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Primary 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)
Primary Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score Five criteria are scored and each one is scored form 0-2 with a total score of 10, a higher score indicating a better outcome. 10 minutes after birth
Primary Neonate status as determined by Umbilical Artery PH determined by lab value 10 minutes after birth
Primary Maternal Coagulopathy determined by lab value end of surgery (4 hours after anesthesia)
Secondary Degree of shivering (severity) Degree of shivering is measured from 0(no shivering)-3(total body shivering) on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]
Secondary Number of patients that need meperidine on arrival to PACU [about 4 hours after anesthesia]
Secondary Degree of shivering (severity) Degree of shivering is measured from 0(no shivering)-3(total body shivering) after 30 minutes in PACU
Secondary Number of patients that need meperidine after 30 minutes in PACU
Secondary 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)
Secondary Number of patients that show Maternal thermal comfort scored form 0-10,a higher number indicating more thermal comfort end of surgery (4 hours after anesthesia)
Secondary Perioperative blood loss end of surgery (4 hours ater anesthesia)
Secondary Hospital Length of Stay Time of admission to time of discharge (about 72 hours after surgery)
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