Thromboelastogram in Postdelivery Preeclamptic Patients

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555630
• Other study ID #: [1167446
• Status: Completed
• Start date: May 22, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications

Intervention

Diagnostic Test:
• Thromboelastogram
Blood sample processing for thromboelastogram

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R time	Reaction time of whole blood	10 minutes
Secondary	K time	Activation time	10 minutes
Secondary	Maximum amplitude	Amplitude in relation to platelet count and function	10 minutes
Secondary	LY-30	Lysis at 30 minutes	30 minutes