Temperature Change, BodyNCT05661136
Maternal Postop Temperature After Cesarean Delivery
A study testing Warm air blower in people with Temperature Change, Body and Cesarean Delivery, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
It is unclear whether routine addition of intra-operative forced-air warming in addition to warmed intravenous fluids during cesarean delivery under spinal anesthesia is beneficial. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Temperature Change, Body, Cesarean Delivery, Spinal Anesthesia
- What is being tested?
- Warm air blower
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Dec 2022to 9 Mar 2023
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent
- Age between 18-50 years old
- American Society of Anesthesiologists (ASA) physical status 2-3
- Gestational age greater than 37 completed weeks
- Singleton pregnancy
- Elective cesarean delivery.
Who cannot join
- Known allergy to local anesthetics
- Contraindication for spinal anesthesia
- Patient refusal
- Bleeding diathesis
- Neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Postoperative Temperature After Cesarean Delivery Under Spinal Anesthesia With Warmed Intravenous Fluids: Randomized Controlled Trial With Versus Without Lower Body Forced Air Warming
It is unclear whether routine addition of intra-operative forced-air warming in addition to warmed intravenous fluids during cesarean delivery under spinal anesthesia is beneficial. In this single-center randomized trial, we aim to test the primary null hypothesis that our current protocol of warmed intravenous fluids is similar to a combination of warmed intravenous fluids with intra-operative lower-body forced-air warming to maintain maternal temperature after cesarean delivery under spinal anesthesia.
We also aim to assess the rate of maternal shivering during and after the procedure between the two groups, the maternal thermal comfort score, neonatal Apgar scores and umbilical pH levels. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to continue our current protocol of warmed intravenous fluids only during cesarean delivery.
Read the detailed description
Primary aim Investigate whether a combination of intra-operative lower-body forced-air warming and warmed IV fluids is superior to our current standard of warmed IV fluids alone in influencing maternal core temperature following spinal anesthesia for cesarean delivery.
Secondary aim
- To compare mean core temperature on arrival to post-anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare incidence of hypothermia among women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare incidence of shivering following recovery in post anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare thermal comfort levels for women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare use of meperidine in post anesthesia care unit (PACU) to treat postoperative shivering, in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare newborn outcomes (rectal temperature at birth, umbilical vein pH \& Apgar scores post-delivery) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- Being tested
- Warm air blower, Control: Lower body blanket not attached to warm air blower
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm air blowerDevice
Lower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position
Control: Lower body blanket not attached to warm air blowerOther
Control: Lower body blanket placed, not attached to warm air blower
| Study group | Role | What they receive |
|---|---|---|
| Warm air blower | Experimental | Intra-operative lower-body forced-air warming after spinal anesthesia and co-loading 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia Receives: Device: Warm air blower |
| Control | Active comparator | Co-loading of 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia Receives: Other: Control: Lower body blanket not attached to warm air blower |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean core temperature
The primary aim is the mean core temperature on arrival to PACU. The means for the two groups will be compared.
Measured: baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge)
Secondary outcomes (7)
Maternal hypothermia
Maternal hypothermia yes/no defined as core body temperature <36°C
Measured: 60 minutes following spinal anesthesia
Shivering
Shivering score - 0 - no shivering
- - One or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity
- - Visible muscular activity confined to one muscle group
- - Visible muscular activity in more than one muscle group
- - Gross muscular activity involving the whole body
Measured: Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge)
Maternal thermal comfort
Maternal thermal comfort scores (• Thermal comfort scale - a 0 to 10 scale will be used with the descriptors to a single question - "How warm or cold are you?
- "Worst imaginable cold", " thermally neutral, " and " insufferably hot " representing the 0, 5, and 10 of the scale, respectively) will be obtained at baseline, 30 minutes during surgery, and on admission to PACU
Measured: baseline, immediately before spinal anesthesia , 60 minutes following spinal anesthesia, and then every 30 minutes for 2 hours (last measurement prior to discharge)
Meperidine
Meperidine administration (timing and dose) used to treat shivering
Measured: Postoperative - up to two hours during PACU recovery after the procedure
Apgar
Apgar scores (at 1 and 5 minutes) will be determined by the pediatrician (not involved in the study)
Measured: 1 and 5 minutes after newborn delivery
Newborn Temperature
Newborn rectal temperature
Measured: Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery
Umbilical vein pH
venous blood gases will be obtained for analysis from a double-clamped segment of umbilical cord
Measured: Immediately following placenta removal intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start13 Dec 2022
- Primary completion8 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two arms: lower body forced air warming versus none
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661136
- Sponsor's protocol ID
- CTIL - 0562-22-TLV -
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2022
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Publications
Haim S, Cohen B, Lustig A, Greenberger C, Aptekman B, Weiniger CF. Lower-body warming and postoperative temperature in cesarean delivery under spinal anesthesia: a randomized controlled trial. Int J Obstet Anesth. 2024 May;58:103990. doi: 10.1016/j.ijoa.2024.103990. Epub 2024 Mar 21. No abstract available.
PubMed 38614895
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Postoperative Temperature After Cesarean Delivery Under Spinal Anesthesia With Warmed Intravenous Fluids: Randomized Controlled Trial With Versus Without Lower Body Forced Air Warming
- ClinicalTrials.gov ID
- NCT05661136
- Acronym / sponsor ID
- CTIL - 0562-22-TLV -
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 22 Dec 2022 (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.
It is unclear whether routine addition of intra-operative forced-air warming in addition to warmed intravenous fluids during cesarean delivery under spinal anesthesia is beneficial. In this single-center randomized trial, we aim to test the primary null hypothesis that our current protocol of warmed intravenous fluids is similar to a combination of warmed intravenous fluids with intra-operative lower-body forced-air warming to maintain maternal temperature after cesarean delivery under spinal anesthesia.
We also aim to assess the rate of maternal shivering during and after the procedure between the two groups, the maternal thermal comfort score, neonatal Apgar scores and umbilical pH levels. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to continue our current protocol of warmed intravenous fluids only during cesarean delivery.
Detailed description
Primary aim Investigate whether a combination of intra-operative lower-body forced-air warming and warmed IV fluids is superior to our current standard of warmed IV fluids alone in influencing maternal core temperature following spinal anesthesia for cesarean delivery.
Secondary aim
- To compare mean core temperature on arrival to post-anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare incidence of hypothermia among women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare incidence of shivering following recovery in post anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare thermal comfort levels for women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare use of meperidine in post anesthesia care unit (PACU) to treat postoperative shivering, in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
- To compare newborn outcomes (rectal temperature at birth, umbilical vein pH \& Apgar scores post-delivery) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two arms: lower body forced air warming versus none
| Arm | Type | Receives |
|---|---|---|
| Warm air blower | Experimental | Device: Warm air blowerIntra-operative lower-body forced-air warming after spinal anesthesia and co-loading 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia |
| Control | Active comparator | Other: Control: Lower body blanket not attached to warm air blowerCo-loading of 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent
- Age between 18-50 years old
- American Society of Anesthesiologists (ASA) physical status 2-3
- Gestational age greater than 37 completed weeks
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Known allergy to local anesthetics
- Contraindication for spinal anesthesia
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 |
|---|---|---|
| Warm air blowerLower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position | Device | Warm air blower |
| Control: Lower body blanket not attached to warm air blowerControl: Lower body blanket placed, not attached to warm air blower | Other | Control |
Primary outcome
The mean core temperature
Time frame: baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge)
The primary aim is the mean core temperature on arrival to PACU. The means for the two groups will be compared.
7 secondary outcomes
Maternal hypothermia
Time frame: 60 minutes following spinal anesthesia
Shivering
Time frame: Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge)
Maternal thermal comfort
Time frame: baseline, immediately before spinal anesthesia , 60 minutes following spinal anesthesia, and then every 30 minutes for 2 hours (last measurement prior to discharge)
Meperidine
Time frame: Postoperative - up to two hours during PACU recovery after the procedure
Apgar
Time frame: 1 and 5 minutes after newborn delivery
Newborn Temperature
Time frame: Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery
Umbilical vein pH
Time frame: Immediately following placenta removal intraoperatively
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 14 Feb 2025.
- Derived from this study: PubMed 38614895Haim S, Cohen B, Lustig A, Greenberger C, Aptekman B, Weiniger CF. Lower-body warming and postoperative temperature in cesarean delivery under spinal anesthesia: a randomized controlled trial. Int J Obstet Anesth. 2024 May;58:103990. doi: 10.1016/j.ijoa.2024.103990. Epub 2024 Mar 21. No abstract available.
- Individual participant dataSharing planned: No. no plan
Related trials for Temperature Change, Body
Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
RecruitingObservational study
Diagnosis and Management of Inflammatory and Infectious Diseases
Infection, Inflammation
Not yet recruiting
Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever
Fever, Temperature Monitoring
Recruiting
Thermal Therapies in the Treatment of Muscle Injuries
Hamstring Injuries, Hamstring Muscle Repair
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm air blower in people with Temperature Change, Body and Cesarean Delivery, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 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 14 Feb 2025. 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 Israel. 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?
The mean core temperature (time frame: baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661136, which also lists 1 linked publication.
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 14 Feb 2025.