Maternal Postop Temperature After Cesarean Delivery

NCT05661136 | Completed DMC

• 1 other identifier: CTIL - 0562-22-TLV -
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Temperature Change, Body; Cesarean Delivery; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maternal hypothermia

  60 minutes following spinal anesthesia

• Shivering

  Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge)

• 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)

• Meperidine

  Postoperative - up to two hours during PACU recovery after the procedure

• Apgar

  1 and 5 minutes after newborn delivery

Study Arms (2)

Warm air blower

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Warm air blower DEVICE

Lower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position

Warm air blower

Control: Lower body blanket not attached to warm air blower OTHER

Control: Lower body blanket placed, not attached to warm air blower

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Known allergy to local anesthetics
• Contraindication for spinal anesthesia
• Patient refusal
• Bleeding diathesis
• Neuropathy

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv SMO

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postanesthesia care unit nurses assess primary outcome and will not know the group assignment Sample size was calculated for the primary outcome of difference between the groups in maternal temperature on arrival to the post-anesthesia care unit. We calculated the a priori sample size, WinPepi, based upon a prior publication that compared Active-Warming versus No-Warming, mean(standard deviation) 35.9(0.5)0 C versus 35.5(0.5), power 90%, 0.05 two-sided significance (Cobb et al). For clinical significance we calculated sample size with a mean difference of 0.50 C, with SD 0.5, power 90%, two sided significance with potential for 10% dropouts, total 66 women, 33 per group, and without dropouts, 22 per group total 44 women.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: two arms: lower body forced air warming versus none

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 22, 2022
• Study Start: December 13, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 9, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)