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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intrauterine Growth Restriction

Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| postpartum full term neonates<br>immediate postpartum full term neonates with no intrauterine growth restricted | |
| intrauterine growth restricted neonates<br>preterm or full-term intrauterine growth restricted neonates | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic hemostasis measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboelastography, Intrauterine Growth Restriction, Neonate, Gestational age, hemostasis, coagulopathy