Clinical trial NCT04907578: Thromboelastography (TEG) In the Intrauterine Growth Restriction (IUGR) Neonatal Population by Gestational Age
Official title: Thromboelastography (TEG) In the Intrauterine Growth Restriction (IUGR) Neonatal Population by Gestational Age
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intrauterine Growth Restriction
Keywords: Thromboelastography
Intrauterine Growth Restriction
Neonate
Gestational age
hemostasis
coagulopathy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from Magee-Womens Hospital

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Dynamic hemostasis measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
timeFrame: Immediately postpartum
Secondary outcomes:
measure: Clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
timeFrame: Immediately postpartum
measure: Rate of clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations
timeFrame: Immediately postpartum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jonathan H. Waters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sayce AC, Neal MD, Leeper CM. Viscoelastic monitoring in trauma resuscitation. Transfusion. 2020 Oct;60 Suppl 6:S33-S51. doi: 10.1111/trf.16074.