Clinical trial NCT06962241: Effect of Maintenance of Intraoperative Normothermia in Cesarean Section on Thermal Comfort, Serum Cortisol and Apgar Score: A Randomized Controlled Trial
Official title: Effect of Maintenance of Intraoperative Normothermia in Cesarean Section on Thermal Comfort, Serum Cortisol and Apgar Score: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: PREGNANCY
NORMOTERMIA
APGAR SCORE
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Concerns of pregnant women who are warmed by a heating pad
timeFrame: Questions will be asked half an hour before the caesarean section
Secondary outcomes:
measure: Thermal Comfort of Pregnant Women Warmed with a Heating Pad
timeFrame: will be measured half an hour after the cesarean section
Other outcomes:
measure: The effect of warming pregnant women with a heating pad on the Apgar scores of their babies
timeFrame: The Apgar score of the baby born after cesarean section will be evaluated at the 1st and 5th minutes.
measure: Effect of heating pad on shivering of pregnant women
timeFrame: will be measured half an hour before and half an hour after the caesarean section
measure: warming affects serum cortisol level of newborns
timeFrame: After birth, blood will be taken from the umbilical cord and serum cortisol levels will be checked.
Locations:
Study officials:
References:
citation: 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.