Perioperative Warming Measures in Cesarean Delivery

Not Applicable

Recruiting

• Conditions: Hypothermia; Anesthesia; Hypothermia, Sequela; Hypothermia, Newborn

• Registration Number: NCT05015582
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-20
• Study Start: 2021-08-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in maternal core body temperature	preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Number of women with hypothermia	preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)	Hypothermia is indicated as core temperature \< 36 °C
Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score	10 minutes after birth	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.
Neonate status as determined by Umbilical Artery PH	10 minutes after birth	determined by lab value
Maternal Coagulopathy	end of surgery (4 hours after anesthesia)	determined by lab value

Secondary Outcome Measures

Name	Time	Method
Degree of shivering (severity)	after administration of meperidine, if it applies (about 30 minutes in PACU)	Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Number of patients that need meperidine	after 30 minutes in PACU
Number of patients that show Maternal thermal comfort	end of surgery (4 hours after anesthesia)	scored form 0-10,a higher number indicating more thermal comfort
Perioperative blood loss	end of surgery (4 hours ater anesthesia)
Hospital Length of Stay	Time of admission to time of discharge (about 72 hours after surgery)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States