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Completed

NCT Number: NCT07757009

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

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.

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Key information

Conditions

Perioperative Hypothermia Maternal Hypothermia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hamad Medical Corporation

Al Rayyan, Baladiyat ad Dawhah, 3050, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Maternal Shivering Score

    Time frame: This 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.

Other outcomes

  1. Neonatal Temperature at Birth

    Time frame: Immediately after birth

    Neonatal axillary temperature measured immediately after delivery.

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Acronym: FAM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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