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

NCT04907578 | Withdrawn

• 1 other identifier: STUDY21040124
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Growth Restriction

Keywords

Thromboelastography; Intrauterine Growth Restriction; Neonate; Gestational age; hemostasis; coagulopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately postpartum

Secondary Outcomes (2)

• Clot formation measured by Thromboelastography (TEG) in intrauterine growth restriction (IUGR) neonatal population verse non-IUGR populations

  Immediately postpartum

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

  Immediately postpartum

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Magee-Womens Hospital

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 32567712 RESULT

• Sayce AC, Neal MD, Leeper CM. Viscoelastic monitoring in trauma resuscitation. Transfusion. 2020 Oct;60 Suppl 6:S33-S51. doi: 10.1111/trf.16074.

  PMID: 33089933 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The investigators plan to collect discarded blood specimens (1-2 mL of placental umbilical vein blood following umbilical cord clamping) in order to perform TEG analysis, in duplicate when possible, immediately following the live birth of a viable neonate. No additional specimens will be collected for this study.

MeSH Terms

Conditions

Fetal Growth Retardation; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jonathan H. Waters, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: August 12, 2021
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

US (1)