Thromboelastography in Non-elective Cesarean Delivery

Study Overview
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Brief Summary
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The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

Detailed Description
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The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). TEG is a point- of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.

Official Title
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Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery

Conditions
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Bleeding

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstetric in-patients Laboring patients with Epidurals for Labor Analgesia going for non-elective Cesarean Patients of all ethnic backgrounds will be included Singleton pregnancy ASA 1 or 2 Exclusion Criteria: Patients with underlying coagulation disorders. Patients with thrombocytopenia (platelet count <100). Patients with pregnancy-induced hypertension, pre-eclampsia. Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants. Patients requiring elective Cesarean delivery. Patients with significant obstetric or medical disease. No patients <18 years of age will be recruited.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-elective Cesarean Delivery<br>We will only enroll patients undergoing non-elective CS with an 'epidural top-up' for surgical anesthesia. By definition, our study will only apply to laboring women with working labor epidurals (which were provided for labor analgesia). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated blood loss; Coagulation data (Thromboelastography, Laboratory) | This study will allow us to collect more information about the hemostatic effects that occur during non-elective Cesarean delivery. This information will add to current knowledge base (which we have published) about coagulation changes in the peripartum period in patients undergoing non-elective Cesarean section. | pre and post cesarean delivery, an expected average of 75 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic indices | Hematologic indices will include: Hemoglobin concentration and platelet count. | Pre and post cesarean delivery, an expected average of 75 minutes |