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Thromboelastography (TEG) In the Intrauterine Growth Restriction (IUGR) Neonatal Population by Gestational Age

2021年8月12日 更新者:Jonathan H. Waters、University of Pittsburgh
The investigators aim to improve the understanding of TEG in this population in an effort to improve outcomes in a population at high risk in both the presence and absence of blood product transfusions.

研究概览

地位

撤销

详细说明

The investigators plan to 1.) examine dynamic hemostasis as measured by TEG in the intrauterine growth restriction (IUGR) neonatal population due to a high risk of requiring blood transfusions, 2.) determine the influence of gestational age on TEG in this population, and 3.) examine the utility of TEG as a tool for identifying coagulopathy in IUGR neonates.

The investigators hypothesize that thromboelastography parameters will change with gestational age in the IUGR population in a manner similar to non-IUGR populations and that neonatal comorbidities, maternal factors, and socioeconomic status will influence TEG values; TEG is likely a useful marker of dynamic hemostasis in this neonatal subpopulation.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • UPMC Magee-Womens Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Participants will be recruited from Magee-Womens Hospital

描述

Inclusion Criteria:

Participants included for medical record data and blood sample collection will be:

  • Neonates diagnosed with intrauterine growth restriction, defined as a weight below the estimated 10th percentile and accordingly identified as such in any peripartum evaluation AND
  • May have additional comorbidities AND
  • Full term IUGR neonates will be have a gestational age of 37 weeks or greater OR
  • Preterm IUGR neonates will have a gestational age less than 37 weeks OR
  • Preterm IUGR neonates will have a gestational age less than 37 weeks

Participants included for medical record review data collection ONLY will be:

Mothers of eligible neonates

Exclusion Criteria:

  • Constitutionally (familial) low birth weight, i.e. small for gestational age, babies OR
  • Born to women with life threatening coexisting morbidities (this may include severe pre-eclampsia, diabetes or suspected infections including HIV or herpes) OR
  • Neonates with an abnormal delivery or perinatal course including:

Fetal demise, death in the first week after birth, neonatal encephalopathy, meconium aspiration, and physical birth injuries (fractures and brachial plexus injuries)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
postpartum full term neonates
immediate postpartum full term neonates with no intrauterine growth restricted
intrauterine growth restricted neonates
preterm or full-term intrauterine growth restricted neonates

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Dynamic hemostasis measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
大体时间:Immediately postpartum
Discarded blood specimens (1-2 mL of placental umbilical vein blood following umbilical cord clamping) will be needed to perform TEG analysis, in duplicate when possible, immediately following the live birth of a viable neonate. The output of the TEG will include maximum amplitude (mm), which is a reflection of clot strength and a function of the maximum dynamic properties of fibrin and platelet bonding and correlates to platelet function.
Immediately postpartum

次要结果测量

结果测量
措施说明
大体时间
Clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
大体时间:Immediately postpartum
Discarded blood specimens (1-2 mL of placental umbilical vein blood following umbilical cord clamping) will be needed to perform TEG analysis, in duplicate when possible, immediately following the live birth of a viable neonate. The output of the TEG will include R time (min), which represents a period of latency from start to initial fibrin formation.
Immediately postpartum
Rate of clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
大体时间:Immediately postpartum
Discarded blood specimens (1-2 mL of placental umbilical vein blood following umbilical cord clamping) will be needed to perform TEG analysis, in duplicate when possible, immediately following the live birth of a viable neonate. The output of the TEG will include α-Angle (degree), which measures the speed at which fibrin build-up and cross-linking takes place, assesses the rate of clot formation.
Immediately postpartum

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jonathan H. Waters, MD、University of Pittsburgh

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年8月12日

初级完成 (实际的)

2021年8月12日

研究完成 (实际的)

2021年8月12日

研究注册日期

首次提交

2021年5月25日

首先提交符合 QC 标准的

2021年5月25日

首次发布 (实际的)

2021年5月28日

研究记录更新

最后更新发布 (实际的)

2021年8月18日

上次提交的符合 QC 标准的更新

2021年8月12日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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