HypothermiaNCT06259942
Impact of Active Heating on Maternal and Neonatal Well-being
A study testing İntervention 1 group (underbody heater group only) and İntervention 2 group (group using both underbody heater and heated iv liquid) in people with Hypothermia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- İntervention 1 group (underbody heater group only) and İntervention 2 group (group using both underbody heater and heated iv liquid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2022to 22 Sep 2022
- 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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective cesarean section with spinal anesthesia,
- 37 weeks of gestation and above,
- with ASA I and ASA II scores,
- Pregnant women with a healthy fetus,
- The preoperative fasting period is between 2 to 12 hours,
- Pregnant women who were normothermic (36 to 37.5°C) preoperatively
Who cannot join
- Those requiring emergency delivery or with comorbidities
- Multiple pregnancies,
- Anemic pregnant women with a hemoglobin value below 11 g/dl according to the World Health Organization (2001),
- Central body temperature above 37.5°C and below 36°C on the morning of surgery
- Pregnant women with a history of malnutrition, thyroid function and other endocrine disorders, Parkinson's disease, peripheral circulatory disorders, diabetes mellitus, heart disease and stroke,
- Pregnant women with chronic bowel problems and urinary system problems were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Usıng Heated Intravenous Fluıds wıth Underbody Warmers on Maternal and Neonatal Well-Beıng in Cesarean Sectıon Operatıons
This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being
Read the detailed description
This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being.
The study was conducted in a university hospital with a total of 105 women who gave birth by cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35 intervention 2 (both underbody heater and heated IV fluid group) and 35 control group. The research data were collected with the Individual Information Form, Patient Follow-up Form and Visual Analog Scale. APGAR score, body temperature, cortisol and glucose levels were evaluated in the infant and body temperature, intraoperative bleeding, shivering, postoperative pain, gas and urination were evaluated in the mother between the three groups.
Descriptive statistics, Chi-square, Shapiro Wilks, Friedman, Wilxocon, Kuruskal Wallis and Mann Whitney U test were used in the evaluation of the data and significance level p<0.05 was accepted.
- Conditions
- Hypothermia
- Being tested
- İntervention 1 group (underbody heater group only), İntervention 2 group (group using both underbody heater and heated iv liquid), Control Group
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntervention 1 group (underbody heater group only)Other
Also called MEDWARM W-300 IM-190MS
Resistive heaters can be set to 38-40°C and are used together with the control unit to which they are connected. In the study, an underbody heater (MEDWARM W 300 IM 190MS branded) system measuring 1900x500x40mm was used. In this study, the underbody heater was set to 38°C for patients. Before use, a surgical drape was placed over it to prevent direct patient contact.
İntervention 2 group (group using both underbody heater and heated iv liquid)Other
Also called MEDWARM W-300 IM-190MS, QW3 Blood and Serum Warmer
IV fluids should be warmed to protect patients from unwanted hypothermia during surgery. One liter of saline solution given at room temperature decreases body temperature by 0.25˚C in adults. Therefore, the fluids given to the patient should be heated to 33 40˚C. In the guideline published by the Turkish Anesthesia Society, it is stated that if more than 1000 2000 mL of fluid is to be given to patients, it should be heated at 37°C (TARD, 2013). In this study, both IV fluids were heated between 37 and 39°C and given to the patient and heated with carbon fiber underbody heaters.
Control GroupOther
Also called group without active heating
no active heating treatment was applied in this group
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 group | Experimental | only the group heated throughout surgery with carbon fiber underbody heaters Receives: Other: İntervention 1 group (underbody heater group only); Other: Control Group |
| Intervention 2 group | Active comparator | the group that was both warmed throughout the operation with carbon fiber underbody heaters and given warmed intravenous fluids Receives: Other: İntervention 2 group (group using both underbody heater and heated iv liquid) |
| Control group | No intervention | routine practice of the hospital where the surgery was performed (no heater applied group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal well- being
body temperature( degrees cantigrade), intraoperative bleeding (hemoglobin) , shivering(0-10) , postoperative pain (0-10), gas and urination
Measured: two day
Secondary outcomes (1)
Newborn well- being
body tempereture (degrees cantigrade), APGAR score , cortisol and glucose levels
Measured: two day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start19 Jun 2022
- Primary completion20 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Talhaoglu, Osmaniye Korkut Ata University
- Investigators
- Dilek TALHAOĞLU, PhD, Principal investigator, She was a doctoral student at Erciyes University, Institute of Health Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259942
- Sponsor's protocol ID
- Surgery-01
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: December 2025
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Usıng Heated Intravenous Fluıds wıth Underbody Warmers on Maternal and Neonatal Well-Beıng in Cesarean Sectıon Operatıons
- ClinicalTrials.gov ID
- NCT06259942
- Acronym / sponsor ID
- Surgery-01
- Conditions
- Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 14 Feb 2024 (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.
This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being
Detailed description
This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being.
The study was conducted in a university hospital with a total of 105 women who gave birth by cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35 intervention 2 (both underbody heater and heated IV fluid group) and 35 control group. The research data were collected with the Individual Information Form, Patient Follow-up Form and Visual Analog Scale. APGAR score, body temperature, cortisol and glucose levels were evaluated in the infant and body temperature, intraoperative bleeding, shivering, postoperative pain, gas and urination were evaluated in the mother between the three groups.
Descriptive statistics, Chi-square, Shapiro Wilks, Friedman, Wilxocon, Kuruskal Wallis and Mann Whitney U test were used in the evaluation of the data and significance level p<0.05 was accepted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 group | Experimental | Other: İntervention 1 group (underbody heater group only), Other: Control Grouponly the group heated throughout surgery with carbon fiber underbody heaters |
| Intervention 2 group | Active comparator | Other: İntervention 2 group (group using both underbody heater and heated iv liquid)the group that was both warmed throughout the operation with carbon fiber underbody heaters and given warmed intravenous fluids |
| Control group | No intervention | –routine practice of the hospital where the surgery was performed (no heater applied group) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Elective cesarean section with spinal anesthesia,
- 37 weeks of gestation and above,
- with ASA I and ASA II scores,
- Pregnant women with a healthy fetus,
- The preoperative fasting period is between 2 to 12 hours,
Key exclusion criteria (6 listed)
- Those requiring emergency delivery or with comorbidities
- Multiple pregnancies,
- Anemic pregnant women with a hemoglobin value below 11 g/dl according to the World Health Organization (2001),
- Central body temperature above 37.5°C and below 36°C on the morning of surgery
- Pregnant women with a history of malnutrition, thyroid function and other endocrine disorders, Parkinson's disease, peripheral circulatory disorders, diabetes mellitus, heart disease and stroke,
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 |
|---|---|---|
| İntervention 1 group (underbody heater group only)Also: MEDWARM W-300 IM-190MSResistive heaters can be set to 38-40°C and are used together with the control unit to which they are connected. In the study, an underbody heater (MEDWARM W 300 IM 190MS branded) system measuring 1900x500x40mm was used. In this study, the underbody heater was set to 38°C for patients. Before use, a surgical drape was placed over it to prevent direct patient contact. | Other | Intervention 1 group |
| İntervention 2 group (group using both underbody heater and heated iv liquid)Also: MEDWARM W-300 IM-190MS, QW3 Blood and Serum WarmerIV fluids should be warmed to protect patients from unwanted hypothermia during surgery. One liter of saline solution given at room temperature decreases body temperature by 0.25˚C in adults. Therefore, the fluids given to the patient should be heated to 33 40˚C. In the guideline published by the Turkish Anesthesia Society, it is stated that if more than 1000 2000 mL of fluid is to be given to patients, it should be heated at 37°C (TARD, 2013). In this study, both IV fluids were heated between 37 and 39°C and given to the patient and heated with carbon fiber underbody heaters. | Other | Intervention 2 group |
| Control GroupAlso: group without active heatingno active heating treatment was applied in this group | Other | Intervention 1 group |
Primary outcome
Maternal well- being
Time frame: two day
body temperature( degrees cantigrade), intraoperative bleeding (hemoglobin) , shivering(0-10) , postoperative pain (0-10), gas and urination
1 secondary outcome
Newborn well- being
Time frame: two day
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 2024.
- Individual participant dataSharing planned: No. December 2025
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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.
Dilek TALHAOĞLU, PhD principal investigator
She was a doctoral student at Erciyes University, Institute of Health Sciences.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İntervention 1 group (underbody heater group only) and İntervention 2 group (group using both underbody heater and heated iv liquid) in people with Hypothermia, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 14 Feb 2024. 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 Turkey (Türkiye). 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?
Maternal well- being (time frame: two day). 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 14 Feb 2024.