Thromboelastogram in Postdelivery Preeclamptic Patients

Effect of Age on Reference Values for Thromboelastography in Pregnant Women With Pre-eclampsia

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; Coagulation Disorder; Preeclampsia
• Intervention / Treatment: Diagnostic test: Thromboelastogram

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Term pregnant patients with preeclampsia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-cesarean preeclampsia	Diagnostic test: Thromboelastogram; Blood sample processing for thromboelastogram
Post spontaneous vaginal delivery preeclampsia	Diagnostic test: Thromboelastogram; Blood sample processing for thromboelastogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R time	Reaction time of whole blood	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K time	Activation time	10 minutes
Maximum amplitude	Amplitude in relation to platelet count and function	10 minutes
LY-30	Lysis at 30 minutes	30 minutes

Collaborators and Investigators

• Sponsor: Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hypertension, Pregnancy-Induced; Hemostatic Disorders; Blood Coagulation Disorders; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: [1167446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No