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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-12

Study Completion Date

2021-08-12

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.

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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.

Conditions

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Intrauterine Growth Restriction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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postpartum full term neonates

immediate postpartum full term neonates with no intrauterine growth restricted

No interventions assigned to this group

intrauterine growth restricted neonates

preterm or full-term intrauterine growth restricted neonates

No interventions assigned to this group

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)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes