Maternal Postop Temperature After Cesarean Delivery

Not Applicable

Completed

• Conditions: Temperature Change, Body; Cesarean Delivery; Spinal Anesthesia
• Interventions: Device: Warm air blower

• Registration Number: NCT05661136
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-12-06
• Study Start: 2022-12-13
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2022-12-22
• Primary Completion: 2023-03-08
• Study Completion: 2023-03-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm air blower	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maternal thermal comfort	baseline, immediately before spinal anesthesia , 60 minutes following spinal anesthesia, and then every 30 minutes for 2 hours (last measurement prior to discharge)	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
Apgar	1 and 5 minutes after newborn delivery	Apgar scores (at 1 and 5 minutes) will be determined by the pediatrician (not involved in the study)
Newborn Temperature	Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery	Newborn rectal temperature
Maternal hypothermia	60 minutes following spinal anesthesia	Maternal hypothermia yes/no defined as core body temperature \<36°C
Shivering	Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge)	Shivering score - 0 - no shivering; 1. - One or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity; 2. - Visible muscular activity confined to one muscle group; 3. - Visible muscular activity in more than one muscle group; 4. - Gross muscular activity involving the whole body
Umbilical vein pH	Immediately following placenta removal intraoperatively	venous blood gases will be obtained for analysis from a double-clamped segment of umbilical cord
Meperidine	Postoperative - up to two hours during PACU recovery after the procedure	Meperidine administration (timing and dose) used to treat shivering

Trial Locations

Locations (1)

Tel Aviv SMO; 🇮🇱 Tel Aviv, Israel