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临床试验/NCT06991985
NCT06991985尚未招募不适用

Analysis of Factors Associated With The Occurrence of Amniotic Fluid Entry in Patients Undergoing Caesarean Section

Second Hospital of Shanxi Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
STN

研究概览

简要总结

To compare serum STN (Neuraminic acid-N-acetylgalactose)antigen concentrations in patients undergoing cesarean section and to study the factors associated with amniotic fluid entry.Compare the serum complement C4 concentration in patients in the amniotic fluid admission group with those in the non-admission group to study whether amniotic fluid admission triggers the body's immune response.To record the patients' blood pressure, heart rate, blood oxygen, and the occurrence of related symptoms and adverse reactions at the time of admission, at the time of blood collection, at the time of discharge from the room, and at the time of the occurrence of haemodynamic changes.

详细描述

All patients were routinely fasted for 8 h and abstained from drinking for 4 h. After entering the operating theatre, intravenous access was opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation and patient's symptoms were continuously monitored during the operation. After obtaining informed consent for anaesthesia from the patient and his family, intrathecal anaesthesia or general anaesthesia was administered according to the situation. Venous blood was drawn from the patient 30 min after the foetus was dissected out, and samples were preserved to measure the concentration of serum STN antigen and the concentration of complement C4; data were collected through the resident workstation system and the manual anaesthesia system, and the patient's information included age, history of allergy, number of deliveries, and history of combining with other illnesses; and the pregnancy information included Placenta type, amniotic fluid, hypertensive disorders of pregnancy, and whether or not the pregnancy was multiple; delivery data included whether or not elective caesarean section was performed, operator factors, intensity of contractions, method of rupture of membranes, and anaesthesia method.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Approved consent and informed consent of the patient by the Ethics Committee of the Second Hospital of Shanxi Medical University;
  • •ASA classification of I-III;
  • •Age 20-50 years old;
  • •No previous history of psychiatric diseases or psychotropic drugs;

排除标准

  • •Suffer from diseases of the cardiorespiratory system;
  • •Those with communication difficulties who were unable to complete the screening questionnaire;

结局指标

主要结局

STN

时间窗: 24 hours

Serum STN levels

C4

时间窗: 24 hours

Serum C4 levels

次要结局

未报告次要终点

研究者

发起方
Second Hospital of Shanxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zheng Guo

professor

Second Hospital of Shanxi Medical University

研究点 (1)

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