Effect of Maintenance of Intraoperative Normothermia in Cesarean Section on Thermal Comfort, Serum Cortisol and Apgar Score: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Concerns of pregnant women who are warmed by a heating pad
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
Warming group
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.
干预措施: Warming group (Other)
Control Group
The patients in this group are given routine care practices of the clinic.
结局指标
主要结局
Concerns of pregnant women who are warmed by a heating pad
时间窗: 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".
次要结局
- Thermal Comfort of Pregnant Women Warmed with a Heating Pad(will be measured half an hour after the cesarean section)
研究者
Sinem Öztürkler
Lecturer Dr
Kocaeli University