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临床试验/NCT07534891
NCT07534891已完成不适用

The Effect of Compression Stockings and Leg Elevation on Hemodynamic Stability in Elective Cesarean Sections Under Spinal Anesthesia: A Single-Blind Randomized Controlled Trial

Seçil Yavaş1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Maternal intraoperative hypotension

研究概览

简要总结

Aim:

This study aimed to evaluate the effects of compression stockings and leg elevation on maternal intraoperative hypotension, vasopressor requirement, and neonatal well-being parameters in women undergoing elective cesarean section spinal anesthesia.

Methods:

This single-blind randomized controlled experimental study was conducted in the obstetrics service and operating room of Afşin State Hospital between November 1, 2023, and February 20, 2025. A total of 90 pregnant women who met the inclusion criteria were randomly assigned into three groups: the compression stockings group (n=30), the leg elevation group (n=30), and the control group (n=30). Spinal anesthesia was administered to all participants according to a standardized protocol. Maternal systolic, diastolic, and mean arterial blood pressure, as well as heart rate, were monitored at regular intervals during the intraoperative period. The occurrence of hypotension, vasopressor use, and side effects such as nausea and vomiting were recorded. Neonatal outcomes included the 5-minute APGAR score and umbilical venous blood gas parameters (pH and base excess). Data were analyzed using appropriate statistical methods.

Results:

Intraoperative systolic, diastolic, and mean arterial blood pressure values were significantly higher in both the compression stockings and leg elevation groups compared to the control group (p<0.05). The rate of vasopressor use was significantly lower in both intervention groups compared to the control group (p<0.05). There were no statistically significant differences among the groups in terms of neonatal APGAR scores, umbilical venous pH, and base excess values (p>0.05).

Conclusion:

The use of compression stockings and leg elevation in women undergoing elective cesarean section تحت spinal anesthesia are effective, safe, and feasible non-pharmacological methods for maintaining maternal hemodynamic stability. These interventions reduce vasopressor requirements and hypotension-related side effects without adversely affecting short-term neonatal outcomes. The findings suggest that these methods can be integrated into clinical nursing practice for the prevention of spinal anesthesia-induced hypotension.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Gestational age between 37-40 weeks, Planned elective cesarean section, Maternal age between 19-40 years, Singleton pregnancy, Planned spinal anesthesia, Estimated fetal weight between 2500-4000 g.

排除标准

  • Known hypertensive disorders, History of severe lower extremity injury, History of deep vein thrombosis, Use of anticoagulant therapy, Placental invasion or placental localization abnormalities with a high risk of bleeding, Requirement for general anesthesia, Known fetal anomalies, Signs of acute or chronic fetal distress, Development of maternal complications during the operation.

研究组 & 干预措施

Compression stockings

Experimental

Moderate-pressure graduated compression stockings were applied

干预措施: compression stockings (Device)

Leg elevation

Experimental

After spinal anesthesia, a 30° leg elevation was applied to the patient throughout the surgery.

干预措施: Leg elevation (Other)

Control

No Intervention

Routine surgical preparation is performed.

结局指标

主要结局

Maternal intraoperative hypotension

时间窗: throughout the cesarean section

Maternal hypotension during spinal anesthesia

Maternal intraoperatif hipotansiyon

时间窗: throughout the cesarean section

Maternal intraoperatif hipotansiyon

次要结局

未报告次要终点

研究者

发起方
Seçil Yavaş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seçil Yavaş

UZMAN HEMŞİRE

TC Erciyes University

研究点 (1)

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