Peri-Operative Forced Air Warming During Elective Cesarean Section Under Spinal Anesthesia Prevent Maternal and Fetal Hypothermia?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hamad Medical Corporation
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence of maternal hypothermia (<36°C)
Study Overview
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.
Detailed Description
Spinal anesthesia impairs thermoregulation by inhibiting vasoconstriction and redistributing core heat to peripheral compartments. As a result, parturients undergoing cesarean delivery are at increased risk of peri-operative hypothermia (<36°C). Even mild hypothermia is associated with shivering, increased oxygen consumption, and maternal discomfort.
This prospective randomized controlled trial compared preoperative forced-air warming with standard thermal care in term parturients undergoing elective cesarean delivery under spinal anesthesia.
The study was conducted between June 2023 and December 2025. A total of 120 participants were enrolled and randomized equally into two groups. Maternal core temperature trends, incidence of hypothermia, shivering, thermal comfort, and neonatal outcomes were analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors were blinded to treatment allocation. Participants, care providers, and investigators were aware of the assigned intervention.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •• Age ≥18 years
- •Term pregnancy (≥37 weeks' gestation)
- •Scheduled elective cesarean delivery
- •ASA physical status I-II
- •Undergoing spinal anesthesia
- •Provided written informed consent
Exclusion Criteria
- •• Emergency cesarean section
- •Preoperative fever (>38°C) or hypothermia
- •Thyroid or significant metabolic disorders
- •Known intrauterine infection
- •Contraindication to spinal anesthesia
- •Refusal to participate
Arms & Interventions
Perioperative Forced-Air Warming
Participants received perioperative forced-air warming during elective cesarean delivery under spinal anesthesia in addition to standard perioperative care.
Intervention: Forced-Air Warming (Device)
Standard Care
Participants received standard perioperative care without forced-air warming during elective cesarean delivery under spinal anesthesia.
Outcomes
Primary Outcomes
Incidence of maternal hypothermia (<36°C)
Time Frame: From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).
Maternal hypothermia is defined as a core body temperature \<36.0°C measured intraoperatively and in the immediate postoperative period.
Incidence of Maternal Hypothermia
Time Frame: From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).
Maternal hypothermia is defined as a core body temperature of \<36.0°C measured intraoperatively and in the immediate postoperative period.
Secondary Outcomes
- Maternal Shivering Score(This period extends from the preoperative phase through surgery and into the first hour in the post-anesthesia care unit (PACU).)
Investigators
Dr. Eynas Omer Ibrahim Abdalla
Consultant Anesthesiology
Hamad Medical Corporation