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NCT Number: NCT06962241

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

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.

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Key information

Conditions

Pregnancy

Age range

19 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Warming group

Other

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.

Primary outcomes

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

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

    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".

Secondary outcomes

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

    Time frame: will be measured half an hour after the cesarean section

    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.

Other outcomes

  1. The effect of warming pregnant women with a heating pad on the Apgar scores of their babies

    Time frame: The Apgar score of the baby born after cesarean section will be evaluated at the 1st and 5th minutes.

  2. Effect of heating pad on shivering of pregnant women

    Time frame: will be measured half an hour before and half an hour after the caesarean section

    The heating pad will be measured with the shivering scale in pregnant women. Zero means no shake, while 3 means the worst possible shake.

  3. warming affects serum cortisol level of newborns

    Time frame: After birth, blood will be taken from the umbilical cord and serum cortisol levels will be checked.

Study contacts

Contact information is provided by the study sponsor or research team.

SİNEM ÖZTÜRKLER

CONTACT

[email protected]

+90 262 4759

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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