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PregnancyNCT06962241

Effect of Maintenance of Intraoperative Normothermia in Cesarean Section on Thermal Comfort, Serum Cortisol and Apgar Score: A Randomized Controlled Trial

A study testing Warming group in people with Pregnancy, run by Kocaeli University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Cesarean section is a common method of delivery worldwide today. According to WHO, cesarean section accounts for more than 1 in 5 (21%) of all births, and it is predicted that approximately one-third (29%) of births will be by cesarean section by 2030. Read more about this study

Who is it for?
Ages 19 to 39 years, women only
Conditions the study is for
Pregnancy
What is being tested?
Warming group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Jun 2025to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 39 years
  • Women only
  • No healthy volunteers
  • Adult

Inclusion Criteria:• Being 19 years of age or older pregnant

  • Being at least a primary school graduate
  • Having an elective cesarean section with spinal/epidural anesthesia
  • Being at or above the 38th week of pregnancy
  • Being in the ASA I (Normal, healthy person with no disease or systemic problem other than surgical pathology that does not cause a systemic disorder) class
  • Not being diagnosed with high-risk pregnancy (such as oligodydroamnios, premature membrane rupture, gestational diabetes mellitus, preeclampsia, fetal tachycardia, nonreactive NST, intrauterine growth retardation)
  • Having a body mass index of >19 kg/m2 and <40 kg/m2
  • Having a singleton pregnancy
  • Having a healthy fetus
  • Having a fasting period of 2-6 hours before surgery
  • Being normothermic (36-37.5°C) (tympanic measurement) before surgery

Exclusion Criteria: •Having comorbidities that require emergency delivery or accompany it (severe preeclampsia, bleeding placenta previa, abruption placenta, cord prolapse, fetal distress)

  • Need for intensive care in the mother or newborn after cesarean section
  • Being anemic with a hemoglobin value below 10 g/dl according to the World Health Organization (2001)
  • Not having platelet values within the reference values
  • Having any disease that will disrupt the bleeding clotting mechanism (hemophilia, liver failure, vitamin K deficiency, etc.)
  • Having a body core temperature above 37.5°C and below 36°C on the morning of surgery
  • Having malnutrition, thyroid function and other endocrine disorders, Parkinson's, peripheral circulatory disorders, Diabetes Mellitus, heart disease and a history of stroke
  • Having any deterioration on the skin surface of the arms and legs (ecchymosis, edema, urticaria, etc.)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

SİNEM ÖZTÜRKLER contact

+90 262 4759

sinem.ozturkler@kocaeli.edu.tr

About this study

Cesarean section is a common method of delivery worldwide today. According to WHO, cesarean section accounts for more than 1 in 5 (21%) of all births, and it is predicted that approximately one-third (29%) of births will be by cesarean section by 2030. Although cesarean section is a vital and life-saving surgery, it can unnecessarily put mothers and babies at risk for short- and long-term health problems when performed without a medical necessity. Unintended perioperative hypothermia, defined as the inadvertent lowering of core temperature below 36°C during surgery, is a well-known complication of anesthesia. Hypothermia can increase the risk of infection by suppressing the immune system, prolonging the recovery process, and triggering postpartum complications. Maintaining maternal body temperature during cesarean section helps reduce postoperative complications, reduce the risk of infection, and accelerate the recovery process. It is also critical for the health of the baby. Keeping the newborn's body temperature stable can help minimize risks such as hypoxia at birth. However, there are increasing studies showing that temperature control is not only limited to maternal health but also has serious effects on the baby after birth. Therefore, it is understood that maintaining body temperature during cesarean section is an important factor in improving the quality of life for both individuals. This article aims to deeply examine the role of temperature control during cesarean section on maternal and fetal health and the benefits of this intervention.

Conditions
Pregnancy
Being tested
Warming group
Keywords
PREGNANCY, NORMOTERMIA, APGAR SCORE

What participants receive

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

  • Warming groupOther

    When the pregnant women in the experimental group were laid on the operating table, they were heated from the back with a heating pad. The heating pad remained on the pregnant woman's back throughout the cesarean section. The cesarean section took an average of 35 minutes from the first surgical incision to the completion of the incision after spinal/epidural anesthesia.

Study groups in NCT06962241
Study groupRoleWhat they receive
Warming groupExperimentalWhen the pregnant women in the experimental group were laid on the operating table, they were heated from the back with a heating pad. The heating pad remained on the pregnant woman's back throughout the cesarean section. The cesarean section took an average of 35 minutes from the first surgical incision to the completion of the incision after spinal/epidural anesthesia.
Receives: Other: Warming group
Control GroupNo interventionThe patients in this group are given routine care practices of the clinic.

What is being measured

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

  1. Concerns of pregnant women who are warmed by a heating pad

    Anxiety of pregnant women warmed with a heating pad will be measured with the Trait Anxiety Inventory (STAI). It is indicated by selecting one of the following options: "(1) None, (2) A Little, (3) A Lot and (4) Completely".

    Measured: Questions will be asked half an hour before the caesarean section

Secondary outcomes (1)

  1. Thermal Comfort of Pregnant Women Warmed with a Heating Pad

    The Thermal Comfort scale will be used to measure the pregnant women's comfort after the Caesarean section, which was warmed with a heating pad.

    Measured: will be measured half an hour after the cesarean section

Timeline

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

  1. First posted8 May 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06962241
Sponsor's protocol ID
41380
Status last verified
Apr 2025
First submitted
29 Apr 2025
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Munday J, Osborne S, Yates P, Sturgess D, Jones L, Gosden E. Preoperative Warming Versus no Preoperative Warming for Maintenance of Normothermia in Women Receiving Intrathecal Morphine for Cesarean Delivery: A Single-Blinded, Randomized Controlled Trial. Anesth Analg. 2018 Jan;126(1):183-189. doi: 10.1213/ANE.0000000000002026.

    PubMed 28514320

  • Ozturkler S, Ozhanli Y, Sahin A, Simsek A, Cakir A. Effect of Active Rewarming on Normothermia, Maternal and Neonatal Outcomes in Elective Cesarean Section: A Randomized Controlled Trial. J Perianesth Nurs. 2026 Jun 19:S1089-9472(26)00184-X. doi: 10.1016/j.jopan.2026.05.029. Online ahead of print.

    PubMed 42322342

Questions about this trial

What is this clinical trial studying?

A study testing Warming group in people with Pregnancy, run by Kocaeli University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SİNEM ÖZTÜRKLER (+90 262 4759, sinem.ozturkler@kocaeli.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concerns of pregnant women who are warmed by a heating pad (time frame: Questions will be asked half an hour before the caesarean section). 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 NCT06962241, which also lists 2 linked publications.

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 8 May 2025.

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