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临床试验/NCT05191251
NCT05191251已完成不适用

Retrospective Assessment of the Risk of Peripartum Hemorrhage in Pregnant Women : Retrospective Assessment of the Diagnostic Performance of the HEMSTOP Standardized Questionnaire

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 3,588 人开始时间: 2022年1月13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
3,588
试验地点
1
主要终点
Sensitivity and specificity lab tests

研究概览

简要总结

The diagnostic performance of the HEMSTOP (Hematoma, hEmorrhage, Menorrhagia, Surgery, Tooth extraction, Obstetrics, Parents) standardized questionnaire collected during the preoperative anesthesia consultation in order to detect a deficit in hemostasis associated with the risk of hemorrhage in pregnant women will be analyzed. The primary aim of the study is to assess the sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests. The second aim of the study is to assess the sensitivity and specificity of the HEMSTOP questionnaire in predicting postpartum hemorrhage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Full-term pregnant women who have given birth vaginally or by cesarean section. Patients for whom a HEMSTOP questionnaire could be carried out in prepartum, during the pre-delivery anesthesia consultation.
  • Patients who received follow-up during pregnancy as recommended. Age over 18

排除标准

  • Patients age under the age of 18 Patients who did not have follow-up during pregnancy as recommended Patients taking long-term anticoagulants and/or antiaggregants Patients with a language barrier

结局指标

主要结局

Sensitivity and specificity lab tests

时间窗: 24 hours

Sensitivity and the specificity of the HEMSTOP questionnaire to identity patients with an abnormal first-line hemostasis test requiring further development by performing second-line hemostasis tests will be calculated. Firstline hemostasis tests are aPTT, PT, INR, fibrinogen level and platelet count.

次要结局

  • Sensitivity and specificity hemorrhage(24 hours)

研究者

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

Denis SCHMARTZ

Head, department of Anesthesiology

Brugmann University Hospital

研究点 (1)

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