Perioperative Warming Measures in Cesarean Delivery
Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery
1 other identifier
interventional
100
1 country
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
August 20, 2021
CompletedStudy Start
First participant enrolled
August 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJanuary 10, 2023
January 1, 2023
1.9 years
July 22, 2021
January 6, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Change in 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
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
Neonate status as determined by Umbilical Artery PH
determined by lab value
10 minutes after birth
Maternal Coagulopathy
determined by lab value
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]
Degree of shivering (severity)
after 30 minutes in PACU
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)
- +3 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALPreop: 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
Control Group
ACTIVE COMPARATORPreop: 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
Interventions
Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
lower body forced air warming at ambient (32˚C) for at least 30 minutes
Use of upper body forced air warming intra-operative at ambient (32˚C)
upper body forced air warming intra-operative at ambient (32˚C)
upper body forced air warming intra-operative at ambient (42˚C)
Lower body forced air warming intra-operative at ambient (32˚C)
Lower body forced air warming intra-operative at ambient (42˚C)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacy Norrell, MD
The University of Texas Health Science Center, Houston
Central Study Contacts
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
August 1, 2023
Study Completion
August 1, 2023
Last Updated
January 10, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share