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Study will not commence
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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. |
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Inclusion Criteria:
Participants included for medical record data and blood sample collection will be:
Participants included for medical record review data collection ONLY will be:
Mothers of eligible neonates
Exclusion Criteria:
Fetal demise, death in the first week after birth, neonatal encephalopathy, meconium aspiration, and physical birth injuries (fractures and brachial plexus injuries)
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Participants will be recruited from Magee-Womens Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan H. Waters, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32567712 | Result | 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. | |
| 33089933 | Result | Sayce AC, Neal MD, Leeper CM. Viscoelastic monitoring in trauma resuscitation. Transfusion. 2020 Oct;60 Suppl 6:S33-S51. doi: 10.1111/trf.16074. |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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The investigators plan to collect discarded blood specimens (1-2 mL of placental umbilical vein blood following umbilical cord clamping) in order to perform TEG analysis, in duplicate when possible, immediately following the live birth of a viable neonate. No additional specimens will be collected for this study.
| 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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |