Evaluation of Novel Point of Care Coagulation System in Pregnant Women

Study Overview
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Brief Summary
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In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.

Detailed Description
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Unexpected bleeding continues to be an issue that confronts anesthesiologists. Obstetric bleeding spearheads as the leading cause of maternal mortality and morbidity. One of the hurdles that clinicians confront is a lack of point of care coagulation system that can hasten the clinical management strategy in the right direction. Conventional methods take considerable time to obtain results. TEG and ROTEM are currently doing the job however these two modalities requires expertise and proficient training to perform test and interpret results. The level of expertise to run the TEG and ROTEM poses hurdles for providing coagulation around the clock as it requires trained operators. What is currently required for efficient and effective management of obstetric hemorrhage is a point of care coagulation system in the operating room and or labor and delivery suite that is user friendly, easy and quick to perform. In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer system to assess coagulation rapidly with ease.

Official Title
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Evaluation of Novel Point of Care Coagulation System in Pregnant Women

Conditions
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Hemorrhage, Coagulation Delay

Intervention / Treatment
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* Device: Quantra Analyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman at 37-41 weeks gestation Exclusion Criteria: Hypertension Preeclampsia Gestational diabetes Preexisting coagulopathy History of deep vein thrombosis (DVT) Medications that impair coagulation History of pulmonary embolism or thrombosis Women in active labor receiving intravenous fluids or oxytocin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pregnant Women<br>All subjects will have the same intervention. Samples will be taken and manipulated in the laboratory for use of the Hemosonic Qauntra Analyzer | Device: Quantra Analyzer<br>* Subjects blood will be manipulated in the lab and will be tested with the Quantra Analyzer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of coagulation using Quantra system. | How Fibrinogen level of the patient is reflected by FCS (Fibrinogen Clot Strength of Quantra) | Baseline | 
| Determine how other conventional tests such as PT, PTT, and INR relate to clotting time of Quantra. | How PT, PTT, and INR level of the patient is reflected by Clot Strength of Quantra | Baseline |