Thromboelastogram in Postdelivery Preeclamptic Patients

NCT ID: NCT03555630

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Preeclampsia Coagulation Disorder Pregnancy Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Post-cesarean preeclampsia

Thromboelastogram

Intervention Type DIAGNOSTIC_TEST

Blood sample processing for thromboelastogram

Post spontaneous vaginal delivery preeclampsia

Thromboelastogram

Intervention Type DIAGNOSTIC_TEST

Blood sample processing for thromboelastogram

Interventions

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Thromboelastogram

Blood sample processing for thromboelastogram

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Efrain Riveros Perez, MD

Assistant Professor Department of Anesthesiology and Perioperative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Augusta University

Augusta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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[1167446

Identifier Type: -

Identifier Source: org_study_id

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