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Completed

NCT Number: NCT03555630

Thromboelastogram in Postdelivery Preeclamptic Patients

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.

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Key information

Conditions

Preeclampsia Cardiovascular Diseases Coagulation Disorder Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Augusta University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thromboelastogram

Diagnostic Test

Blood sample processing for thromboelastogram

Primary outcomes

  1. R time

    Time frame: 10 minutes

    Reaction time of whole blood

Secondary outcomes

  1. K time

    Time frame: 10 minutes

    Activation time

  2. Maximum amplitude

    Time frame: 10 minutes

    Amplitude in relation to platelet count and function

  3. LY-30

    Time frame: 30 minutes

    Lysis at 30 minutes

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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