Status:
WITHDRAWN
Thromboelastography (TEG) In the Intrauterine Growth Restriction (IUGR) Neonatal Population by Gestational Age
Lead Sponsor:
University of Pittsburgh
Conditions:
Intrauterine Growth Restriction
Eligibility:
FEMALE
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 transfusion...
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.) de...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 12 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04907578
Start Date
August 12 2021
End Date
August 12 2021
Last Update
August 18 2021
Active Locations (1)
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1
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213