Hypothermia; AnesthesiaNCT05015582

Perioperative Warming Measures in Cesarean Delivery

A study testing Pre op upper body forced air warming (32˚C), Pre op lower body forced air warming (32˚C) and Pre op fluids (45˚C) in people with Hypothermia; Anesthesia and Hypothermia, Newborn, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
What is being tested?: Pre op upper body forced air warming (32˚C), Pre op lower body forced air warming (32˚C) and Pre op fluids (45˚C)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 23 Aug 2021to 14 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

scheduled for elective cesarean section under neuraxial anesthesia
singleton pregnancy

Who cannot join

gestational age of less than 37 week
emergency cesarean

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery

The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby

Conditions: Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
Being tested: Pre op upper body forced air warming (32˚C), Pre op lower body forced air warming (32˚C), Pre op fluids (45˚C), Intra op upper body forced air warming (32˚C), Intra op fluids at room temperature
Medical subject headings: Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pre op upper body forced air warming (32˚C)Device
Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op lower body forced air warming (32˚C)Device
lower body forced air warming at ambient (32˚C) for at least 30 minutes
Pre op fluids (45˚C)Device
fluids from warmed cabinet set at 45˚C
Intra op upper body forced air warming (32˚C)Device
Use of upper body forced air warming intra-operative at ambient (32˚C)
Intra op fluids at room temperatureDevice
IV fluids at room temperature
Intra op upper body forced air warming at (32˚C)Device
upper body forced air warming intra-operative at ambient (32˚C)
Intra op upper body forced air warming at (42˚C)Device
upper body forced air warming intra-operative at ambient (42˚C)
Intra op lower body forced air warming at (32˚C)Device
Lower body forced air warming intra-operative at ambient (32˚C)
Intra op lower body forced air warming at (42˚C)Device
Lower body forced air warming intra-operative at ambient (42˚C)
Intra op fluid (42˚C)Device
IV fluids with hotline fluid warmer set at 42˚C

Study groups in NCT05015582
Study group	Role	What they receive
Treatment	Experimental	Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C Receives: Device: Pre op upper body forced air warming (32˚C); Device: Pre op lower body forced air warming (32˚C); Device: Pre op fluids (45˚C); Device: Intra op upper body forced air warming (32˚C); Device: Intra op upper body forced air warming at (32˚C); Device: Intra op upper body forced air warming at (42˚C); Device: Intra op lower body forced air warming at (32˚C); Device: Intra op lower body forced air warming at (42˚C); Device: Intra op fluid (42˚C)
Control Group	Active comparator	Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature Receives: Device: Pre op upper body forced air warming (32˚C); Device: Pre op lower body forced air warming (32˚C); Device: Pre op fluids (45˚C); Device: Intra op upper body forced air warming (32˚C); Device: Intra op fluids at room temperature; Device: Intra op upper body forced air warming at (32˚C)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maternal Core Body Temperature
Measured: preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia)
Number of Women With Hypothermia
Hypothermia is indicated as core temperature < 36 °C
Measured: preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Neonate Status as Determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score
The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.
Measured: 1 minutes after birth, 5 minutes after birth
Umbilical Artery pH
Measured: 10 minutes after birth
Maternal Coagulopathy
Measured: end of surgery (4 hours after anesthesia)

Secondary outcomes (8)

Degree of Shivering (Severity)
Degree of shivering is measured from 0(no shivering)-3(total body shivering), a higher score indicates greater shivering.
Measured: on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]
Number of Patients That Need Meperidine
Measured: on arrival to PACU [about 4 hours after anesthesia]
Number of Patients That Need Meperidine
Measured: after 30 minutes in PACU
Degree of Shivering (Severity)
Degree of shivering is measured from 0(no shivering)-3(total body shivering)
Measured: after administration of meperidine, if it applies (about 30 minutes in PACU)
Maternal Thermal Comfort
Maternal thermal comfort has a total score range from 0 to 10,a higher number indicating more thermal comfort
Measured: end of surgery (4 hours after anesthesia)
Perioperative Blood Loss
Measured: end of surgery (4 hours after anesthesia)
Hospital Length of Stay
Measured: Time of admission to time of discharge (about 72 hours after surgery)
Neonate Blood Sugar Level
Measured: 10 minutes after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 202114 Dec 2021

First posted20 Aug 2021
Study start23 Aug 2021
Primary completion14 Dec 2021
Study completion14 Dec 2021

Why it stopped: lack of support

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypothermia; AnesthesiaStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05015582
Sponsor's protocol ID: HSC-MS-21-0011
Status last verified: Mar 2026
First submitted: 22 Jul 2021
Last updated: 14 May 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Shivering, Hypothermia
Enrolling by invitationObservational study
Study of the Prevalence of Postoperative Hypothermia in Adults Undergoing Non-Cardiac Surgery in Spanish Post-Anesthesia Care Units
Hypothermia Following Anesthesia

All Hypothermia; Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery
ClinicalTrials.gov ID: NCT05015582
Acronym / sponsor ID: HSC-MS-21-0011
Conditions: Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
Study type: Interventional
Recruitment status: TerminatedReason stopped: lack of support
Enrolment: 16 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 23 Aug 2021 (actual)
Primary completion: 14 Dec 2021 (actual)
Study completion: 14 Dec 2021 (actual)
First posted: 20 Aug 2021 (actual)
Results: Posted 14 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Device: Pre op upper body forced air warming (32˚C), Device: Pre op lower body forced air warming (32˚C), Device: Pre op fluids (45˚C), Device: Intra op upper body forced air warming (32˚C), Device: Intra op upper body forced air warming at (32˚C), Device: Intra op upper body forced air warming at (42˚C), Device: Intra op lower body forced air warming at (32˚C), Device: Intra op lower body forced air warming at (42˚C), Device: Intra op fluid (42˚C)Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C
Control Group	Active comparator	Device: Pre op upper body forced air warming (32˚C), Device: Pre op lower body forced air warming (32˚C), Device: Pre op fluids (45˚C), Device: Intra op upper body forced air warming (32˚C), Device: Intra op fluids at room temperature, Device: Intra op upper body forced air warming at (32˚C)Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

scheduled for elective cesarean section under neuraxial anesthesia
singleton pregnancy

Key exclusion criteria (2 listed)

gestational age of less than 37 week
emergency cesarean

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
Pre op upper body forced air warming (32˚C)Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes	Device	Control Group, Treatment
Pre op lower body forced air warming (32˚C)lower body forced air warming at ambient (32˚C) for at least 30 minutes	Device	Control Group, Treatment
Pre op fluids (45˚C)fluids from warmed cabinet set at 45˚C	Device	Control Group, Treatment
Intra op upper body forced air warming (32˚C)Use of upper body forced air warming intra-operative at ambient (32˚C)	Device	Control Group, Treatment
Intra op fluids at room temperatureIV fluids at room temperature	Device	Control Group
Intra op upper body forced air warming at (32˚C)upper body forced air warming intra-operative at ambient (32˚C)	Device	Control Group, Treatment
Intra op upper body forced air warming at (42˚C)upper body forced air warming intra-operative at ambient (42˚C)	Device	Treatment
Intra op lower body forced air warming at (32˚C)Lower body forced air warming intra-operative at ambient (32˚C)	Device	Treatment
Intra op lower body forced air warming at (42˚C)Lower body forced air warming intra-operative at ambient (42˚C)	Device	Treatment
Intra op fluid (42˚C)IV fluids with hotline fluid warmer set at 42˚C	Device	Treatment

Primary outcome

Maternal Core Body Temperature
Time frame: preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia)
Number of Women With Hypothermia
Time frame: preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
Hypothermia is indicated as core temperature < 36 °C
Neonate Status as Determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score
Time frame: 1 minutes after birth, 5 minutes after birth
The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.
Umbilical Artery pH
Time frame: 10 minutes after birth
Maternal Coagulopathy
Time frame: end of surgery (4 hours after anesthesia)

8 secondary outcomes

Degree of Shivering (Severity)
Time frame: on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]
Number of Patients That Need Meperidine
Time frame: on arrival to PACU [about 4 hours after anesthesia]
Number of Patients That Need Meperidine
Time frame: after 30 minutes in PACU
Degree of Shivering (Severity)
Time frame: after administration of meperidine, if it applies (about 30 minutes in PACU)
Maternal Thermal Comfort
Time frame: end of surgery (4 hours after anesthesia)
Perioperative Blood Loss
Time frame: end of surgery (4 hours after anesthesia)
Hospital Length of Stay
Time frame: Time of admission to time of discharge (about 72 hours after surgery)
Neonate Blood Sugar Level
Time frame: 10 minutes after birth

Results and safety

Results posted to the registry on 14 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	10	9
Control Group	6	6

Primary outcome: Maternal Core Body Temperature

Time frame: preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia). Mean (Standard Deviation). Unit: degrees Fahrenheit

Measure	Treatment n = 10	Control Group n = 6
preoperative/beginning of surgery	96.48 (1.28)	96.48 (1.40)
postoperative/end of surgery (4 hours after anesthesia)	97.33 (1.33)	97.3 (0.98)

Primary outcome: Number of Women With Hypothermia

Time frame: preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia). Count of participants. Unit: Participants

Measure	Treatment n = 10	Control Group n = 6
preoperative/beginning of surgery	5	2
postoperative/end of surgery (4 hours after anesthesia)	4	1

Primary outcome: Neonate Status as Determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score

Time frame: 1 minutes after birth, 5 minutes after birth. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment n = 8	Control Group n = 2
1 minute after birth	8.1 (0.64)	8 (0)
5 minutes after birth	8.6 (0.51)	8 (0)

Population analysed: Data were collected and analyzed only from participants who had an Apgar score recorded by study personnel on the data collection form at the time after birth.

Primary outcome: Umbilical Artery pH

Time frame: 10 minutes after birth. Mean (Standard Deviation). Unit: pH

Measure	Treatment n = 1	Control Group n = 2
Value	7.24	7.17 (0.084)

Population analysed: Data were collected only from participants who had an Umbilical Artery pH recorded by study personnel on the data collection form at the time of birth.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 72 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment: Mothers	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Control Group: Mothers	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Treatment: Infants	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Control Group: Infants	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hypothermia; Anesthesia

Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Shivering, Hypothermia
Enrolling by invitationObservational study
Study of the Prevalence of Postoperative Hypothermia in Adults Undergoing Non-Cardiac Surgery in Spanish Post-Anesthesia Care Units
Hypothermia Following Anesthesia

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.

Stacy Norrell, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 May 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 United States. 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?

Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maternal Core Body Temperature (time frame: preoperative/beginning of surgery, postoperative/end of surgery (4 hours after anesthesia)). The study lists 5 primary outcomes in all. 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 NCT05015582.

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 May 2026.