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

Peri-Operative Forced Air Warming During Elective Cesarean Section Under Spinal Anesthesia Prevent Maternal and Fetal Hypothermia?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07757009
Acronym
FAM
Enrollment
120
Registered
2026-08-11
Start date
2023-06-01
Completion date
2025-12-31
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Hypothermia, Perioperative 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

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.

Interventions

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

Sponsors

Hamad Medical Corporation
Lead SponsorINDUSTRY

Study design

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of maternal hypothermia (<36°C)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 HypothermiaFrom 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

MeasureTime frameDescription
Maternal Shivering ScoreThis period extends from the preoperative phase through surgery and into the first hour in the post-anesthesia care unit (PACU).Maternal shivering will be assessed using a four-point shivering scale ranging from 0 to 3: 0 = no shivering; 1 = intermittent, low-intensity shivering; 2 = moderate shivering; and 3 = continuous, intense shivering. Higher scores indicate greater severity of shivering.

Countries

Qatar

Contacts

PRINCIPAL_INVESTIGATORDr Eynas Omer Ibrahim Abdalla, Arab Board

Hamad Medical Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026