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

Sponsor

University of Pittsburgh (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04907578

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Growth Restriction

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 12, 2021

Actual Primary Completion Date :

Aug 12, 2021

Actual Study Completion Date :

Aug 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Dynamic hemostasis measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations [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.

Secondary Outcome Measures

Clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations [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.
Rate of clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)