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

Kocaeli University

Status: Not yet enrolling

Conditions: Pregnancy

Treatments: Other: Warming group

Study type: Interventional

Funder types: Other

Identifiers

NCT06962241

41380

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 19 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Warming group

Experimental group

Description:

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.

Treatment:

Other: Warming group

Control Group

No Intervention group

Description:

The patients in this group are given routine care practices of the clinic.