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临床试验/NCT06857162
NCT06857162尚未招募不适用

Comparison of Maternal Hemodynamics During Spinal Anesthesia with Different Cesarean Delivery Positioning

Aswan University1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2025年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
216
试验地点
1
主要终点
To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery.

研究概览

简要总结

Cesarean delivery is a common surgical procedure, and maintaining maternal hemodynamic stability during the procedure is crucial for both maternal and fetal outcomes . Hemodynamic instability, such as hypotension following spinal anesthesia, is a frequent complication and can lead to adverse maternal and neonatal outcomes. Traditionally, after spinal anesthesia, women are positioned supine, sometimes with a slight left lateral tilt to mitigate the risk of aortocaval compression . However, recent studies and clinical observations suggest that delayed supine positioning-keeping the patient in a sitting or semi-sitting position for a period following spinal anesthesiamay improve hemodynamic stability. These alternative positions may help to mitigate the abrupt drop in blood pressure commonly seen after spinal anesthesia by allowing for a more gradual redistribution of blood volume . Understanding the optimal positioning strategy could lead to improved clinical protocols that enhance maternal and fetal safety. By comparing immediate supine positioning with delayed supine positioning (in sitting and semi-sitting positions), this study aims to provide evidence on which positioning strategy offers the best hemodynamic outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • •Pregnant women scheduled for elective cesarean delivery.
  • •Age between 18 and 40 years.
  • •ASA (American Society of Anesthesiologists) physical status II.

排除标准

  • •Emergency cesarean delivery.
  • •Pre-existing cardiovascular disease.
  • •Severe preeclampsia or eclampsia.
  • •Multiple pregnancies.
  • •Known fetal anomalies.

研究组 & 干预措施

Group A (N=72): Immediate Supine Position

Active Comparator

干预措施: Positioninng during Cs (Behavioral)

Group В (N=72): Sitting Position

Experimental

干预措施: Positioninng during Cs (Behavioral)

Group С (N=72): Semi-Sitting Position

Experimental

干预措施: Positioninng during Cs (Behavioral)

结局指标

主要结局

To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery.

时间窗: 9 Months

次要结局

未报告次要终点

研究者

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

Ahmed Yousef Mohamed

Resident of Anethesia and Intensive Care

Aswan University

研究点 (1)

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