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临床试验/NCT06259942
NCT06259942已完成不适用

The Effect of Usıng Heated Intravenous Fluıds wıth Underbody Warmers on Maternal and Neonatal Well-Beıng in Cesarean Sectıon Operatıons

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2022年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
Maternal well- being

研究概览

简要总结

This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being

详细描述

This study was conducted to determine the effects of actively warming the patient and using warmed intravenous (IV) fluid during cesarean section on maternal and infant well-being.

The study was conducted in a university hospital with a total of 105 women who gave birth by cesarean section randomly selected from 35 intervention 1 (only underbody heater group), 35 intervention 2 (both underbody heater and heated IV fluid group) and 35 control group. The research data were collected with the Individual Information Form, Patient Follow-up Form and Visual Analog Scale. APGAR score, body temperature, cortisol and glucose levels were evaluated in the infant and body temperature, intraoperative bleeding, shivering, postoperative pain, gas and urination were evaluated in the mother between the three groups.

Descriptive statistics, Chi-square, Shapiro Wilks, Friedman, Wilxocon, Kuruskal Wallis and Mann Whitney U test were used in the evaluation of the data and significance level p<0.05 was accepted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

women undergoing elective caesarean section

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective cesarean section with spinal anesthesia,
  • 37 weeks of gestation and above,
  • with ASA I and ASA II scores,
  • Pregnant women with a healthy fetus,
  • The preoperative fasting period is between 2 to 12 hours,
  • Pregnant women who were normothermic (36 to 37.5°C) preoperatively

排除标准

  • Those requiring emergency delivery or with comorbidities
  • Multiple pregnancies,
  • Anemic pregnant women with a hemoglobin value below 11 g/dl according to the World Health Organization (2001),
  • Central body temperature above 37.5°C and below 36°C on the morning of surgery
  • Pregnant women with a history of malnutrition, thyroid function and other endocrine disorders, Parkinson's disease, peripheral circulatory disorders, diabetes mellitus, heart disease and stroke,
  • Pregnant women with chronic bowel problems and urinary system problems were not included in the study.

结局指标

主要结局

Maternal well- being

时间窗: two day

body temperature( degrees cantigrade), intraoperative bleeding (hemoglobin) , shivering(0-10) , postoperative pain (0-10), gas and urination

次要结局

  • Newborn well- being(two day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Talhaoglu

principal investigator

Osmaniye Korkut Ata University

研究点 (1)

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