Thromboelastography (TEG) In the Intrauterine Growth Restriction (IUGR) Neonatal Population by Gestational Age
調査の概要
状態
条件
詳細な説明
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.
研究の種類
連絡先と場所
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC Magee-Womens Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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postpartum full term neonates
immediate postpartum full term neonates with no intrauterine growth restricted
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intrauterine growth restricted neonates
preterm or full-term intrauterine growth restricted neonates
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dynamic hemostasis measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
時間枠：Immediately postpartum
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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.
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Immediately postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
時間枠：Immediately postpartum
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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.
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Immediately postpartum
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Rate of clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
時間枠：Immediately postpartum
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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.
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Immediately postpartum
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jonathan H. Waters, MD、University of Pittsburgh
出版物と役立つリンク
一般刊行物
- Waters JH. The role of viscoelastic testing in the management of the parturient. Transfusion. 2020 Oct;60 Suppl 6:S70-S74. doi: 10.1111/trf.15928. Epub 2020 Jun 22.
- Sayce AC, Neal MD, Leeper CM. Viscoelastic monitoring in trauma resuscitation. Transfusion. 2020 Oct;60 Suppl 6:S33-S51. doi: 10.1111/trf.16074.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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