Maternal Postop Temperature After Cesarean Delivery

Maternal Postoperative Temperature After Cesarean Delivery Under Spinal Anesthesia With Warmed Intravenous Fluids: Randomized Controlled Trial With Versus Without Lower Body Forced Air Warming

It is unclear whether routine addition of intra-operative forced-air warming in addition to warmed intravenous fluids during cesarean delivery under spinal anesthesia is beneficial. In this single-center randomized trial, we aim to test the primary null hypothesis that our current protocol of warmed intravenous fluids is similar to a combination of warmed intravenous fluids with intra-operative lower-body forced-air warming to maintain maternal temperature after cesarean delivery under spinal anesthesia.

We also aim to assess the rate of maternal shivering during and after the procedure between the two groups, the maternal thermal comfort score, neonatal Apgar scores and umbilical pH levels. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to continue our current protocol of warmed intravenous fluids only during cesarean delivery.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Temperature Change, Body; Cesarean Delivery
• Intervention / Treatment: Device: Warm air blower; Other: Control: Lower body blanket not attached to warm air blower

Detailed Description

Primary aim Investigate whether a combination of intra-operative lower-body forced-air warming and warmed IV fluids is superior to our current standard of warmed IV fluids alone in influencing maternal core temperature following spinal anesthesia for cesarean delivery.

Secondary aim

1. To compare mean core temperature on arrival to post-anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
2. To compare incidence of hypothermia among women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
3. To compare incidence of shivering following recovery in post anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
4. To compare thermal comfort levels for women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
5. To compare use of meperidine in post anesthesia care unit (PACU) to treat postoperative shivering, in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
6. To compare newborn outcomes (rectal temperature at birth, umbilical vein pH & Apgar scores post-delivery) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv SMO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent
2. Age between 18-50 years old
3. American Society of Anesthesiologists (ASA) physical status 2-3
4. Gestational age greater than 37 completed weeks
5. Singleton pregnancy
6. Elective cesarean delivery.

Exclusion Criteria:

1. Known allergy to local anesthetics

2. Contraindication for spinal anesthesia

   1. Patient refusal
   2. Bleeding diathesis
   3. Neuropathy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warm air blower; Intra-operative lower-body forced-air warming after spinal anesthesia and co-loading 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia	Device: Warm air blower; Lower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position
Active Comparator: Control; Co-loading of 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia	Other: Control: Lower body blanket not attached to warm air blower; Control: Lower body blanket placed, not attached to warm air blower

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean core temperature	The primary aim is the mean core temperature on arrival to PACU. The means for the two groups will be compared.	baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal hypothermia	Maternal hypothermia yes/no defined as core body temperature <36°C	60 minutes following spinal anesthesia
Shivering	Shivering score - 0 - no shivering; - One or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity; - Visible muscular activity confined to one muscle group; - Visible muscular activity in more than one muscle group; - Gross muscular activity involving the whole body	Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge)
Maternal thermal comfort	Maternal thermal comfort scores (• Thermal comfort scale - a 0 to 10 scale will be used with the descriptors to a single question - "How warm or cold are you? o "Worst imaginable cold", " thermally neutral, " and " insufferably hot " representing the 0, 5, and 10 of the scale, respectively) will be obtained at baseline, 30 minutes during surgery, and on admission to PACU	baseline, immediately before spinal anesthesia , 60 minutes following spinal anesthesia, and then every 30 minutes for 2 hours (last measurement prior to discharge)
Meperidine	Meperidine administration (timing and dose) used to treat shivering	Postoperative - up to two hours during PACU recovery after the procedure
Apgar	Apgar scores (at 1 and 5 minutes) will be determined by the pediatrician (not involved in the study)	1 and 5 minutes after newborn delivery
Newborn Temperature	Newborn rectal temperature	Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery
Umbilical vein pH	venous blood gases will be obtained for analysis from a double-clamped segment of umbilical cord	Immediately following placenta removal intraoperatively

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): March 8, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: CTIL - 0562-22-TLV -

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No