Perioperative Forced-Air Warming During Elective Cesarean Delivery Under Spinal Anesthesia

NCT07757009 | Completed DMC

• 1 other identifier: MRC-01-19-378
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative hypothermia is common during cesarean delivery under spinal anesthesia and contributes to maternal discomfort, shivering, and metabolic stress. Active warming systems such as forced-air warming are recommended in perioperative guidelines; however, their effectiveness in obstetric anesthesia remains variably documented. This randomized controlled trial evaluated whether perioperative forced-air warming reduces maternal hypothermia and shivering during elective cesarean section under spinal anesthesia without adversely affecting neonatal outcomes.

Conditions

Perioperative Hypothermia; Maternal Hypothermia

Keywords

Cesarean Section; Elective Cesarean Delivery; Spinal Anesthesia; Maternal Hypothermia; Perioperative Hypothermi; Forced-Air Warming; Active Warming; Maternal Temperature; Shivering; Thermal Comfort; Obstetric Anesthesia; Neonatal Outcomes

Outcome Measures

Primary Outcomes (2)

• Incidence of maternal hypothermia (<36°C)

  Maternal hypothermia is defined as a core body temperature \<36.0°C measured intraoperatively and in the immediate postoperative period.

  From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).

• Incidence of Maternal Hypothermia

  Maternal hypothermia is defined as a core body temperature of \<36.0°C measured intraoperatively and in the immediate postoperative period.

  From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).

Secondary Outcomes (1)

• Maternal Shivering Score

  This period extends from the preoperative phase through surgery and into the first hour in the post-anesthesia care unit (PACU).

Other Outcomes (1)

• Neonatal Temperature at Birth

  Immediately after birth

Study Arms (2)

Perioperative Forced-Air Warming

EXPERIMENTAL

Participants received perioperative forced-air warming during elective cesarean delivery under spinal anesthesia in addition to standard perioperative care.

Device: Forced-Air Warming

Standard Care

NO INTERVENTION

Participants received standard perioperative care without forced-air warming during elective cesarean delivery under spinal anesthesia.

Interventions

Forced-Air Warming DEVICE

Perioperative forced-air warming was administered using a forced-air warming device during elective cesarean delivery under spinal anesthesia to maintain maternal normothermia.

Perioperative Forced-Air Warming

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Term pregnancy (≥37 weeks' gestation)
• Scheduled elective cesarean delivery
• ASA physical status I-II
• Undergoing spinal anesthesia
• Provided written informed consent

You may not qualify if:

• Emergency cesarean section
• Preoperative fever (\>38°C) or hypothermia
• Thyroid or significant metabolic disorders
• Known intrauterine infection
• Contraindication to spinal anesthesia
• Refusal to participate

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Al Rayyan, Baladiyat ad Dawhah, 3050, Qatar

Location

Study Officials

• Dr Eynas Omer Ibrahim Abdalla, Arab Board

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to treatment allocation. Participants, care providers, and investigators were aware of the assigned intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiology

Model Details: Participants were randomized in a 1:1 ratio to receive either perioperative forced-air warming or standard perioperative care during elective cesarean delivery under spinal anesthesia. Participants remained in their assigned group throughout the study.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 11, 2026
• Study Start: June 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)