Thromboelastogram in Postdelivery Preeclamptic Patients

Completed

• Conditions: Coagulation Disorder; Preeclampsia; Pregnancy Complications
• Interventions: Diagnostic Test: Thromboelastogram

• Registration Number: NCT03555630
• Lead Sponsor: Augusta University

Brief Summary

There are no studies evaluating the effect of aging on hemostasis of preeclamptic patients. Additionally, although there are some studies that establish normal reference values for TEG profiles in healthy term pregnant patients, conflicting results have been found in preeclampsia. Reference values are important to establish baseline parameters in cases of pre-eclampsia complicated by postpartum hemorrhage. The investigators will evaluate reference values for TEG in postdelivery preeclamptic patients and the difference between vaginal delivery and cesarean section.

Detailed Description

After approval by the Institutional Review Board and informed consent from participants, the investigators are obtaining blood samples for TEG processing, from pregnant patients admitted to the maternity unit of Augusta University Medical Center. Patients are being classified in 2 groups: term pregnant patients with diagnosis of pre-eclampsia who undergo cesarean section and those having spontaneous vaginal delivery. Each group will be divided into subgroups according to maternal age: 18-25 years, 26-35 years, \>36 years. Pre-eclampsia is defined and classified according to the definitions of the American College of Obstetricians and Gynecologists published in 2013.

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-13
• Primary Completion: 2019-10-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Age > 18 years Mental competence Gestational age > 37-week Informed consent Diagnosis of preeclampsia (with or without features of severity)

Exclusion Criteria

Gestational age < 37-week Known bleeding or thrombotic diathesis Use of aspirin or unfractionated or low-molecular weight heparin within the last 48 hours BMI > 35 Maternal comorbid conditions other than preeclampsia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-cesarean preeclampsia	Thromboelastogram	-
Post spontaneous vaginal delivery preeclampsia	Thromboelastogram	-

Primary Outcome Measures

Name	Time	Method
R time	10 minutes	Reaction time of whole blood

Secondary Outcome Measures

Name	Time	Method
LY-30	30 minutes	Lysis at 30 minutes
K time	10 minutes	Activation time
Maximum amplitude	10 minutes	Amplitude in relation to platelet count and function

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States