Status:
UNKNOWN
Thromboelastographic Profile in Healthy Newborns and Infants of Diabetic Mothers Using TEG6s
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Conditions:
Thromboelastography
Coagulation; Fetus or Newborn
Eligibility:
All Genders
Up to 2 years
Brief Summary
Thromboelastography (TEG) is a laboratory technique used to examine the process of clot formation and degradation by measuring and reporting the kinetic changes, the rate of clot formation, clot stren...
Detailed Description
Thromboelastography (TEG), is a laboratory technique used to examine the process of clot formation and degradation by measuring and reporting the kinetic changes, the rate of clot formation, clot stre...
Eligibility Criteria
Inclusion
- Control Group: Healthy term neonates
- Infants born at 37 weeks gestational age or greater born to mothers of any age with uncomplicated pregnancies
- Comparison Group: Term infants of diabetic mothers
- Infants born at 37 weeks gestational age or greater to mothers of any age with gestational diabetes or Type 1 or Type 2 diabetes, managed with either diet or insulin
Exclusion
- For Both Groups:
- Infants \<37 weeks gestational age
- Multiple gestation pregnancies
- Maternal thrombocytopenia
- Known fetal anomalies
- Known maternal blood clotting disorders or history of thrombosis
- Known family history of clotting disorders
- Chorioamnionitis (diagnosed prior to delivery)
- For "Healthy Term Neonates"
- Intrauterine growth restriction
- Gestational hypertension, chronic hypertension, pre-eclampsia, and/or eclampsia
- Any other major complication of pregnancy or major medical history
Key Trial Info
Start Date :
August 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04917965
Start Date
August 1 2021
End Date
June 30 2023
Last Update
July 23 2021
Active Locations (1)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202