Perioperative HypothermiaFAMNCT07757009
Perioperative Forced-Air Warming During Elective Cesarean Delivery Under Spinal Anesthesia
A study testing Forced-Air Warming in people with Perioperative Hypothermia and Maternal Hypothermia, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perioperative Hypothermia, Maternal Hypothermia
- What is being tested?
- Forced-Air Warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteQatar
- Study dates
- 1 Jun 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age ≥18 years
- Term pregnancy (≥37 weeks' gestation)
- Scheduled elective cesarean delivery
- ASA physical status I-II
- Undergoing spinal anesthesia
- Provided written informed consent
Who cannot join
- • Emergency cesarean section
- Preoperative fever (>38°C) or hypothermia
- Thyroid or significant metabolic disorders
- Known intrauterine infection
- Contraindication to spinal anesthesia
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-Operative Forced Air Warming During Elective Cesarean Section Under Spinal Anesthesia Prevent Maternal and Fetal Hypothermia?
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.
Read the 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.
- Conditions
- Perioperative Hypothermia, Maternal Hypothermia
- Being tested
- Forced-Air Warming
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced-Air WarmingDevice
Perioperative forced-air warming was administered using a forced-air warming device during elective cesarean delivery under spinal anesthesia to maintain maternal normothermia.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Forced-Air Warming | Experimental | Participants received perioperative forced-air warming during elective cesarean delivery under spinal anesthesia in addition to standard perioperative care. Receives: Device: Forced-Air Warming |
| Standard Care | No intervention | Participants received standard perioperative care without forced-air warming during elective cesarean delivery under spinal anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).
Secondary outcomes (1)
Maternal Shivering Score
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.
Measured: This period extends from the preoperative phase through surgery and into the first hour in the post-anesthesia care unit (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Jun 2023
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative HypothermiaStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Eynas Omer Ibrahim Abdalla, Hamad Medical Corporation
- Investigators
- Dr Eynas Omer Ibrahim Abdalla, Arab Board, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757009
- Sponsor's protocol ID
- MRC-01-19-378
- Acronym
- FAM
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Operative Forced Air Warming During Elective Cesarean Section Under Spinal Anesthesia Prevent Maternal and Fetal Hypothermia?
- ClinicalTrials.gov ID
- NCT07757009
- Acronym / sponsor ID
- FAM / MRC-01-19-378
- Conditions
- Perioperative Hypothermia, Maternal Hypothermia
- Keywords
- Cesarean Section, Elective Cesarean Delivery, Spinal Anesthesia, Maternal Hypothermia, Perioperative Hypothermi, Forced-Air Warming, Active Warming, Maternal Temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Perioperative Forced-Air Warming | Experimental | Device: Forced-Air WarmingParticipants received perioperative forced-air warming during elective cesarean delivery under spinal anesthesia in addition to standard perioperative care. |
| Standard Care | No intervention | –Participants received standard perioperative care without forced-air warming during elective cesarean delivery under spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Age ≥18 years
Key exclusion criteria (6 listed)
- • Emergency cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced-Air WarmingPerioperative forced-air warming was administered using a forced-air warming device during elective cesarean delivery under spinal anesthesia to maintain maternal normothermia. | Device | Perioperative Forced-Air Warming |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery
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Goal-Directed Temperature Management During Prolonged Abdominal Surgery
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Intraoperative Temperature Monitoring, Body Temperature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Eynas Omer Ibrahim Abdalla, Arab Board principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced-Air Warming in people with Perioperative Hypothermia and Maternal Hypothermia, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of maternal hypothermia (<36°C) (time frame: From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.