Body Temperature RegulationNCT06725407
Maternal Body Temperature in Caesarean Section
An observational study of Body Temperature Regulation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The effect of maternal body temperature on the postpartum process and the newborn in innatal cesarean section is an important issue that needs to be emphasized. Hypothermia is defined as the patient's body temperature falling below 36.0 °C. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Regulation
- What is being tested?
- Cesarean section
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 10 Jan 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women between the ages of 18-45 who have been given the decision to have a planned caesarean section.
Who may be able to join
- Participants who are 18 years of age or older,
- Able to answer the research questions,
- Without any contagious disease including middle ear infection,
- Volunteer
Who cannot join
- Those with clotting disorders,
- Thyroid disease,
- Those with a body mass index below 18.5,
- Those with mental problems that prevent them from answering questions,
- Those whose babies were born with anomalies,
- Those who had a stillbirth,
- Those who were given special heated blankets and fluids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Maternal Body Temperature Levels on Postoperative Maternal and Neonatal Results: a Cross-Sectional Study
The effect of maternal body temperature on the postpartum process and the newborn in innatal cesarean section is an important issue that needs to be emphasized. Hypothermia is defined as the patient's body temperature falling below 36.0 °C. Because hypothermia and shivering are frequently undesirable morbidities that occur during cesarean section. It can lead to many problems such as coagulopathy, increased transfusion requirement, surgical site infection, delayed metabolism of drugs, prolonged recovery, shivering and thermal discomfort. Many randomized controlled studies have been conducted on the heat regulation processes of women who gave birth by cesarean section, and maternal shivering and infection have been compared with parameters such as neonatal Apgar, blood pH and hypothermia. However, it is observational; data on care, breastfeeding, maternal mobilization and comfort are limited. The aim of this study was to determine the postoperative maternal and neonatal effects of maternal body temperature after cesarean section. An analytical cross-sectional study design will be used. All samples meeting the inclusion criteria of the study will be reached between 10.01.2021-10.01.2022. Research data will be collected using the pregnancy information form, postoperative maternal-neonatal follow-up form, Facial Pain Scale and Temperature Comfort Perception Scale. Research data will be collected using the IBM SPSS Statistic program.
Read the detailed description
Research questions
- What is the prevalence of maternal hypothermia in women who deliver by cesarean section?
- What are the effects of maternal hypothermia on postoperative maternal vital signs, pain, mobilization, nutrition, digestive system, thermal comfort, and breastfeeding in women who deliver by cesarean section?
- What are the effects of maternal hypothermia on neonatal vital signs, Apgar score, first sucking activity, nutrition, oxygen, and intensive care unit requirements in women who deliver by cesarean section? The study will be conducted with an analytical cross-sectional design. The study population will consist of women who gave birth by planned cesarean section in a state hospital in Turkey between 10.01.2021 and 10.01.2022.
The data of the study will be collected using the Pregnant Women Information Form, Postoperative Maternal and Neonatal Follow-up Forms, Faces Pain Scale (FPS) and Thermal Comfort Perception Scale (TCPS).
Statistical analyzes of the data will be performed using IBM SPSS (IBM Corp., NY, USA). Descriptive statistics (number, percentage, mean, standard deviation) will be used to evaluate sociodemographic data. In the comparison of categorical variables, parametric tests (Chi-square, t test, etc.) will be used when the data are normally distributed, and nonparametric tests (Mann-Whitney U test, Kruskal-Walli test, etc.) and regression analysis will be used when the data are not normally distributed.
- Conditions
- Body Temperature Regulation
- Being tested
- Cesarean section
- Keywords
- Cesarean section, Birth, Body Temperature Regulation, Maternal Health, Newborn Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean sectionBehavioural
In the study, the participants' postoperative hypothermia development status was monitored.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Cesarean section Receives: Behavioral: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypothermia
Measured: Postoperative Day 0 (will be measured at 1st hour, 6th hour, 12th hour and 24th hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start10 Jan 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature RegulationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Dilek Aksoy, Kocaeli University
- Investigators
- Sena Dilek Aksoy, Associate Professor, Ph.D., Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725407
- Sponsor's protocol ID
- sdilek11
- Status last verified
- Jan 2021
- First submitted
- 26 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Maternal Body Temperature Levels on Postoperative Maternal and Neonatal Results: a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06725407
- Acronym / sponsor ID
- sdilek11
- Conditions
- Body Temperature Regulation
- Keywords
- Cesarean section, Birth, Body Temperature Regulation, Maternal Health, Newborn Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 10 Dec 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.
The effect of maternal body temperature on the postpartum process and the newborn in innatal cesarean section is an important issue that needs to be emphasized. Hypothermia is defined as the patient's body temperature falling below 36.0 °C. Because hypothermia and shivering are frequently undesirable morbidities that occur during cesarean section. It can lead to many problems such as coagulopathy, increased transfusion requirement, surgical site infection, delayed metabolism of drugs, prolonged recovery, shivering and thermal discomfort. Many randomized controlled studies have been conducted on the heat regulation processes of women who gave birth by cesarean section, and maternal shivering and infection have been compared with parameters such as neonatal Apgar, blood pH and hypothermia. However, it is observational; data on care, breastfeeding, maternal mobilization and comfort are limited. The aim of this study was to determine the postoperative maternal and neonatal effects of maternal body temperature after cesarean section. An analytical cross-sectional study design will be used. All samples meeting the inclusion criteria of the study will be reached between 10.01.2021-10.01.2022. Research data will be collected using the pregnancy information form, postoperative maternal-neonatal follow-up form, Facial Pain Scale and Temperature Comfort Perception Scale. Research data will be collected using the IBM SPSS Statistic program.
Detailed description
Research questions
- What is the prevalence of maternal hypothermia in women who deliver by cesarean section?
- What are the effects of maternal hypothermia on postoperative maternal vital signs, pain, mobilization, nutrition, digestive system, thermal comfort, and breastfeeding in women who deliver by cesarean section?
- What are the effects of maternal hypothermia on neonatal vital signs, Apgar score, first sucking activity, nutrition, oxygen, and intensive care unit requirements in women who deliver by cesarean section? The study will be conducted with an analytical cross-sectional design. The study population will consist of women who gave birth by planned cesarean section in a state hospital in Turkey between 10.01.2021 and 10.01.2022.
The data of the study will be collected using the Pregnant Women Information Form, Postoperative Maternal and Neonatal Follow-up Forms, Faces Pain Scale (FPS) and Thermal Comfort Perception Scale (TCPS).
Statistical analyzes of the data will be performed using IBM SPSS (IBM Corp., NY, USA). Descriptive statistics (number, percentage, mean, standard deviation) will be used to evaluate sociodemographic data. In the comparison of categorical variables, parametric tests (Chi-square, t test, etc.) will be used when the data are normally distributed, and nonparametric tests (Mann-Whitney U test, Kruskal-Walli test, etc.) and regression analysis will be used when the data are not normally distributed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Cesarean sectionCesarean section |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women between the ages of 18-45 who have been given the decision to have a planned caesarean section.
Key inclusion criteria (4 listed)
- Participants who are 18 years of age or older,
- Able to answer the research questions,
- Without any contagious disease including middle ear infection,
- Volunteer
Key exclusion criteria (7 listed)
- Those with clotting disorders,
- Thyroid disease,
- Those with a body mass index below 18.5,
- Those with mental problems that prevent them from answering questions,
- Those whose babies were born with anomalies,
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 |
|---|---|---|
| Cesarean sectionIn the study, the participants' postoperative hypothermia development status was monitored. | Behavioural | Group 1 |
Primary outcome
Postoperative hypothermia
Time frame: Postoperative Day 0 (will be measured at 1st hour, 6th hour, 12th hour and 24th hour)
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 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Sena Dilek Aksoy, Associate Professor, Ph.D. principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Temperature Regulation, run by Kocaeli 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 4 inclusion and 7 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 10 Dec 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?
Postoperative hypothermia (time frame: Postoperative Day 0 (will be measured at 1st hour, 6th hour, 12th hour and 24th hour)). 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 10 Dec 2024.