An observational study in Intrauterine Growth Restriction, sponsored by University of Pittsburgh. Withdrawn at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by University of Pittsburgh · Observational
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
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Participants will be recruited from Magee-Womens Hospital
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)
immediate postpartum full term neonates with no intrauterine growth restricted
preterm or full-term intrauterine growth restricted neonates
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.
Time frame: Immediately postpartum
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.
Time frame: 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.
Time frame: Immediately postpartum
This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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