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临床试验/NCT01506102
NCT01506102
Unknown
不适用

Determination of Thromboelastography Values in Pregnancy and After Delivery

Città di Roma Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年11月最近更新:

概览

阶段
不适用
发起方
Città di Roma Hospital
入组人数
120
试验地点
1
主要终点
TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy

概览

简要总结

The purpose of this study is to establish reference values for thromboelastography (TEM-A) in healthy pregnant women during labor and 2 hours and 24 hours after delivery.

详细描述

Previous, preliminary investigations by using thromboelastography, confirmed that pregnancy is a hypercoaguable state which remains in the first 24 hours postdelivery. Unfortunately results obtained by the existing studies that attempted to establish reference values for TEG suffer considerable bias.

The aim of this study will be to determine the range values for thomboelastography in pregnant women. Since there is no available information on the expected distribution of the outcome, a sequential design will be used. The main endpoint of the analysis will be a reliable estimate for the outcome expected in healthy women after labor. The investigators will state their target estimate as being reliable when the ratio between the estimate and its standard error is smaller than 2.

During labor, 2 hours after delivery and 24 hours postpartum, a venous blood sample will be taken from eligible women for thromboelastographic determination. Whole blood nonadditive TEM will be performed on the TEM-A automated thromboelastometer (Framar Biomedica,Rome, Italy) to obtain the four classical TEM parameters: reaction (R) time, k time, alpha angle and maximum amplitude (MA).

Inclusion criteria Healthy parturients in labor Exclusion criteria parturients who will eventually had: operative or instrumental vaginal delivery, estimated blood loss greater than 500 mL, the occurrence of II and III degree perineal lacerations, any coagulation disorder or anticoagulant therapy

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Participant)

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

  • healthy parturients in labor

排除标准

  • parturients with coagulation defects or anticoagulant therapy

结局指标

主要结局

TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy

时间窗: 24 hours postpartum

To determine the physiological reference individual values of maternal thromboelastography TEM-A during labor, immediately afeter delivery and in the postpartum period.

次要结局

未报告次要终点

研究者

发起方
Città di Roma Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Stirparo

Staff Anesthesiologist

Città di Roma Hospital

研究点 (1)

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